{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2960-s1", "verdict_number": "2960", "title": "Diabetic macular edema with already impaired vision × Anti-VEGF treatment", "view_version": "1.0", "view_created_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "The existing record concerns anti-VEGF treatment in eyes with already impaired vision; the Korean/English text mentions benefits in VISTA/VIVID and Protocol T for diabetic macular edema with vision of 20/50 or worse. Exact baseline vision, disease/edema, eligibility and group denominators in each trial are unverified because direct materials are absent. Protocol V populations/denominators with vision of 20/25 or better are not transferred.", "intervention": "The original description of anti-VEGF treatment benefit in separate trials is preserved. Drugs/formulations, doses, initial/subsequent strategies and actual exposure in each trial are unverified. Immediate aflibercept in Protocol V is not used as the verified intervention in all impaired vision trials, and no new treatment selection or dosing guidance is created.", "dose": "Doses, injection intervals/counts, adherence/changes/discontinuation and individual exposure in each impaired vision trial are absent from the current stored review summary and unverified. Protocol V rescue criteria, 34%/25% and two years are not assigned to impaired vision trials; no new conversion or implementation guidance is created.", "comparator": "Comparators, subsequent/rescue treatment, crossover and actual concurrent exposure in each separate impaired vision trial are unverified. Protocol V initial observation/rescue treatment and laser comparator specifications concern a different visual acuity population/question.", "endpoint": "The selected existing B/note is an original record stating that this is outside the verdict and benefits were established in separate trials. Actual endpoints, time points, change/final values/loss/response, group values/effects/CIs/P values, prespecified important differences, denominators/missingness/models in each trial are unverified because direct materials are absent. Two-year five-letter events, RR 0.83, risk difference −3 percentage points and P=.79 in Protocol V are not identical effect/null-effect values for treatment with impaired vision.", "duration": "Treatment/follow-up durations, actual visits/exposures and observations/missingness in each impaired vision trial are unverified. Two years/104 weeks in Protocol V and two/four years in Protocol W are connected only as preserved context for other trials.", "excluded_extensions": [ "Mixing populations, drugs, comparisons, later strategies, denominators or outcomes from preemptive treatment at 20/25 or better with treatment of already impaired vision at 20/50 or worse", "Turning original observation/rescue into an abandoned-care/no-treatment control, or original worsening criteria into personal treatment/injection-start guidance", "Treating randomized 226/240/236, observed 205/212/208, people/eyes and ITT/imputation as the same complete-case denominators, or calculating new missing/event totals, percentages or intervals", "Turning original RR 0.83, risk difference −3 percentage points/P=.79 and “same three strategies” wording into a newly established exactly zero effect, equivalence or exclusion of all important benefit", "Calculating new injection-start participant counts, injection counts or percentages from observation 34%, laser 25% and about two thirds", "Creating invented direct bibliographies, reports, effects, intervals or independent-replication certification from narrative mentions of VISTA/VIVID or Protocol T/W", "Adding the same Protocol V people/eyes, three arms/sites, time points/outcomes, bibliography/registration or sibling sheets as new independent trials or participants", "Transferring Protocol V funding/product support, company/Network roles, B0/registration or harms to separate trials in impaired vision", "Turning ATC/pressure findings, small event counts or possible visit-related detection bias into safety certification, established harm or new treatment methods", "Inheriting parent scores/axes, historical cross-checks or original narratives as subclaim scores, current review or external reading", "Creating new calculations, invented values, effects/intervals, grades, independence certification or injection/treatment-choice/dosing instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected treatment with impaired vision · Existing subclaim B", "needed": "Distinction between the selected existing question, grade/note and parent scope", "role": "Required", "role_reason": "Preparation item distinguishing Distinction between the selected existing question, grade/note and parent scope to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Distinction between the selected existing question, grade/note and parent scope must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are internally designed; M04 §4.5, §4.6.3; Limitations of the current material conversion follow the review scope and internal design; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed update research connecting the original question with separate evidence; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Anti-VEGF treatment in eyes with already impaired vision has an existing B grade. The original note states that it is outside this verdict and benefit was established in separate trials. No new B assessment or certification is made.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. The subclaim has no score, status or assessment axes; parent D30/axes are not used to fill them. The content and identity of direct trial materials remain separately unverified. Content review remains incomplete.", "missingness": "The subclaim has no score, status or assessment axes; parent D30/axes are not used to fill them. The content and identity of direct trial materials remain separately unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selected record, parent context and separate trial materials" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Already impaired vision · Mention of 20/50", "needed": "Visual acuity range, disease stage and actual recruitment criteria", "role": "Required", "role_reason": "Preparation item distinguishing Visual acuity range, disease stage and actual recruitment criteria to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Visual acuity range, disease stage and actual recruitment criteria must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on visual acuity and the scope of evidence applicability; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing Korean/English text mentions benefits in VISTA/VIVID and Protocol T for diabetic macular edema with vision already reduced to 20/50 or worse. This is not extended to all impaired vision ranges or other diseases.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. Each trial’s exact baseline visual acuity distribution, eligibility, edema/treatment history and group populations are unverified. Protocol V populations with 20/25 or better vision are not transferred. Content review remains incomplete.", "missingness": "Each trial’s exact baseline visual acuity distribution, eligibility, edema/treatment history and group populations are unverified. Protocol V populations with 20/25 or better vision are not transferred.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visual acuity/disease, recruitment and baseline materials for each separate trial" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Anti-VEGF · Formulation/strategy", "needed": "Drug, dose and initial/subsequent strategy in each separate trial", "role": "Required", "role_reason": "Preparation item distinguishing Drug, dose and initial/subsequent strategy in each separate trial to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Drug, dose and initial/subsequent strategy in each separate trial must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing formulation/strategy and question scope; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing question concerns anti-VEGF treatment in eyes with impaired vision. The formulation/strategy of immediate aflibercept in Protocol V is not assigned to all separate trials.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Drugs/formulations, doses, intervals, initial/subsequent strategies and actual exposure in VISTA/VIVID and Protocol T are unverified in the current stored review summary. No treatment or dosing guidance is created. Content review remains incomplete.", "missingness": "Drugs/formulations, doses, intervals, initial/subsequent strategies and actual exposure in VISTA/VIVID and Protocol T are unverified in the current stored review summary. No treatment or dosing guidance is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intervention, drug/formulation, original strategy and exposure materials for each trial" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Separate trial comparators · Rescue treatment", "needed": "Actual comparator and subsequent treatment in each impaired vision trial", "role": "Required", "role_reason": "Preparation item distinguishing Actual comparator and subsequent treatment in each impaired vision trial to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Actual comparator and subsequent treatment in each impaired vision trial must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; M03 §3.2.3, M08 §8.2.2–8.2.3; CHAMGAP adaptation; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing comparison strategies and subsequent treatment; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original mentions names of separate trials and benefits. Protocol V observation/rescue treatment or laser arms are not used as verified comparators for these separate trials.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Comparators, rescue treatment, crossover/additional treatment, sensory matching and actual exposure in each trial are unverified. Content review remains incomplete.", "missingness": "Comparators, rescue treatment, crossover/additional treatment, sensory matching and actual exposure in each trial are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Comparator/subsequent strategy and actual implementation materials for separate trials" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Direct bibliography · VISTA/VIVID/T", "needed": "Trial/report identity, originals and correspondence to the selected question", "role": "Required", "role_reason": "Preparation item distinguishing Trial/report identity, originals and correspondence to the selected question to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Trial/report identity, originals and correspondence to the selected question must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research connecting textual mentions with actual trials/reports; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "VISTA/VIVID and Protocol T are separate trial mentions in the Korean/English text. Baker 2019 Protocol V, the sole report in the existing evidence/citation lists, concerns an initial strategy with vision of 20/25 or better.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. Direct citations/URLs, registrations, report versions and originals for each impaired vision trial are absent from the current stored review summary. No invented report or new reading of originals is created. Content review remains incomplete.", "missingness": "Direct citations/URLs, registrations, report versions and originals for each impaired vision trial are absent from the current stored review summary. No invented report or new reading of originals is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct bibliography, registration/original reports and question correspondence for each separate trial" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Impaired vision benefit · Endpoint", "needed": "Selected outcome definition, units and direction in separate trials", "role": "Required", "role_reason": "Preparation item distinguishing Selected outcome definition, units and direction in separate trials to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Selected outcome definition, units and direction in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4; custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on population/endpoint specifications and effects; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing note and text stating established anti-VEGF benefit in separate trials are preserved. Two-year loss of five letters in Protocol V is not used as a verified identical endpoint in each separate trial.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Vision/function, change/loss/response, prespecified endpoint hierarchy, definitions and units in each trial are unverified. Content review remains incomplete.", "missingness": "Vision/function, change/loss/response, prespecified endpoint hierarchy, definitions and units in each trial are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original endpoint, measurement, analysis and hierarchy materials for each trial" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Effect size · CI · Clinical meaning", "needed": "Original estimate/CI and important difference for separate impaired vision comparisons", "role": "Required", "role_reason": "Preparation item distinguishing Original estimate/CI and important difference for separate impaired vision comparisons to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Original estimate/CI and important difference for separate impaired vision comparisons must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is Chamgap’s own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research examining precision and meaning for the same question; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "RR 0.83, risk difference −3 percentage points and P=.79 in the parent/sibling checklist concern a different strategy comparison in eyes with good vision; they are not impaired vision effect values.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Group values, between-group effects/CIs/P values, models and prespecified important differences in each selected-question trial are unverified in the current stored review summary. No new effect or confirmation is created. Content review remains incomplete.", "missingness": "Group values, between-group effects/CIs/P values, models and prespecified important differences in each selected-question trial are unverified in the current stored review summary. No new effect or confirmation is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original between-group values, CIs, models and important difference materials for each impaired vision trial" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "People/eyes · Denominators/missingness", "needed": "Randomized, observed and analyzed denominators and missingness in separate trials", "role": "Required", "role_reason": "Preparation item distinguishing Randomized, observed and analyzed denominators and missingness in separate trials to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Randomized, observed and analyzed denominators and missingness in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing populations/denominators and missingness assumptions; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "702 people/702 eyes, 226/240/236 and 205/212/208 are Protocol V data. They are not transferred as people/eyes or denominators for separate impaired vision trials.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Group randomized/observed/analyzed populations, people/eyes, duplication, withdrawals/missingness and ITT/PP materials in each trial are unverified. Content review remains incomplete.", "missingness": "Group randomized/observed/analyzed populations, people/eyes, duplication, withdrawals/missingness and ITT/PP materials in each trial are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "People/eyes, group flow, analysis and missingness materials for each trial" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Duration · Visits · Exposure", "needed": "Follow-up/exposure and measurement time points in separate trials", "role": "Required", "role_reason": "Preparation item distinguishing Follow-up/exposure and measurement time points in separate trials to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Follow-up/exposure and measurement time points in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing exposure/time points and selected outcomes; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Two years/104 weeks, rescue criteria and injection initiation proportions in Protocol V are not verified durations/exposures for each impaired vision trial.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Treatment/follow-up, visits/assessment windows, injection counts/adherence, discontinuation and additional treatment in each impaired vision trial are unverified. No new duration/exposure conversion or dosing guidance is made. Content review remains incomplete.", "missingness": "Treatment/follow-up, visits/assessment windows, injection counts/adherence, discontinuation and additional treatment in each impaired vision trial are unverified. No new duration/exposure conversion or dosing guidance is made.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original duration, visits/exposure and actual implementation materials for separate trials" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Allocation · Concealment · Masking", "needed": "Design/allocation and measurement/analysis procedures in separate trials", "role": "Required", "role_reason": "Preparation item distinguishing Design/allocation and measurement/analysis procedures in separate trials to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Design/allocation and measurement/analysis procedures in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on procedures and observed outcomes in each trial; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original citation of web allocation/permuted blocks and masked annual examiners in Protocol V belongs to the parent strategy trial context.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Allocation units, sequence generation/concealment, masking by role, and measurement/assessment/analysis originals for separate impaired vision trials are unverified. Protocol V B0 is not inherited. Content review remains incomplete.", "missingness": "Allocation units, sequence generation/concealment, masking by role, and measurement/assessment/analysis originals for separate impaired vision trials are unverified. Protocol V B0 is not inherited.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation, masking/measurement and analysis records for each separate trial" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Registration · Prespecified endpoints/SAP", "needed": "Registration, prespecified plans and changes in separate trials", "role": "Required", "role_reason": "Preparation item distinguishing Registration, prespecified plans and changes in separate trials to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Registration, prespecified plans and changes in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research connecting prespecified plans and direct reports; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "NCT01909791 and the prespecified two-year five-letter event, ITT and imputation are original Protocol V descriptions. They are not transferred as separate trial plans.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Registration identities, protocols/SAPs, hierarchy/multiplicity, changes and reporting dates of each impaired vision trial are unread. Content review remains incomplete.", "missingness": "Registration identities, protocols/SAPs, hierarchy/multiplicity, changes and reporting dates of each impaired vision trial are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration histories, protocols/SAPs and report correspondence for each trial" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Concurrent care · Treatment attribution", "needed": "Concurrent exposures, crossover and adherence in separate trials", "role": "Required", "role_reason": "Preparation item distinguishing Concurrent exposures, crossover and adherence in separate trials to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Concurrent exposures, crossover and adherence in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on concurrent exposure and effect attribution; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected question’s scope is preserved as treatment with impaired vision.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Glucose/blood pressure management, other ophthalmic treatment/drugs, non-study eyes, adherence/crossover/rescue treatment in separate trials are unverified. No new care or treatment guidance is created. Content review remains incomplete.", "missingness": "Glucose/blood pressure management, other ophthalmic treatment/drugs, non-study eyes, adherence/crossover/rescue treatment in separate trials are unverified. No new care or treatment guidance is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent exposures, care/adherence and additional treatment materials by trial arm" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Protocol V with good vision · Context", "needed": "Populations, comparisons and outcomes of the parent/sibling strategy question and the selected question", "role": "Required", "role_reason": "Preparation item distinguishing Populations, comparisons and outcomes of the parent/sibling strategy question and the selected question to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Populations, comparisons and outcomes of the parent/sibling strategy question and the selected question must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing baseline visual acuity and strategy differences; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Protocol V compared immediate injection, laser and observation/rescue strategies in eyes with vision of 20/25 or better. Original two-year results of 16%/17%/19%, RR 0.83 (0.55–1.27), original risk difference −3 percentage points (−11 to 4) and P=.79 are connected only as context for another question.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. These are not converted into a null effect, effect size or direct independent replication for treatment with impaired vision. Correspondence to actual other trials/populations is unverified. Content review remains incomplete.", "missingness": "These are not converted into a null effect, effect size or direct independent replication for treatment with impaired vision. Correspondence to actual other trials/populations is unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Question/population/strategy correspondence between Protocol V and separate impaired vision trials" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Protocol W · Other outcomes", "needed": "Preventive strategies, anatomy/vision in another trial and the selected question", "role": "Required", "role_reason": "Preparation item distinguishing Preventive strategies, anatomy/vision in another trial and the selected question to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Preventive strategies, anatomy/vision in another trial and the selected question must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.4; CHAMGAP’s boundary for extensions; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on prevention/treatment and anatomical/vision outcome differences; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The textual mention of reduced anatomical complications and no vision benefit at two/four years in Protocol W is context for a separate preventive question. It is not used as the same effect of anti-VEGF treatment with impaired vision.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. Original reports, populations, formulations/strategies, endpoints/denominators, time-specific estimates and relationships are unverified. Content review remains incomplete.", "missingness": "Original reports, populations, formulations/strategies, endpoints/denominators, time-specific estimates and relationships are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct Protocol W reports and population/endpoint/strategy materials" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Separate trial funding · Product support", "needed": "Funding/products and analysis/writing/publication support in separate trials", "role": "Required", "role_reason": "Preparation item distinguishing Funding/products and analysis/writing/publication support in separate trials to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Funding/products and analysis/writing/publication support in separate trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing individual support and report relationships; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "NEI/NIDDK and Regeneron product/site-cost support are original Protocol V descriptions. They are not transferred to each selected impaired vision trial.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Funding, donated products, analysis/writing/publication costs, contracts and roles in each separate trial are unverified in the current stored review summary. Content review remains incomplete.", "missingness": "Funding, donated products, analysis/writing/publication costs, contracts and roles in each separate trial are unverified in the current stored review summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/product, analysis/writing/publication support disclosures for each trial" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Separate trial authors/company · COI", "needed": "Employee/affiliation, contributions, COI and data control in each trial", "role": "Required", "role_reason": "Preparation item distinguishing Employee/affiliation, contributions, COI and data control in each trial to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Employee/affiliation, contributions, COI and data control in each trial must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on author/company roles and report relationships; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Descriptions of company/Network roles in Protocol V are context for the parent strategy report. They do not verify identical independence/relationships for each impaired vision trial.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Author affiliations/employment, contributions, company involvement, data/editorial/submission authority and COI disclosures for each trial are unread. Content review remains incomplete.", "missingness": "Author affiliations/employment, contributions, company involvement, data/editorial/submission authority and COI disclosures for each trial are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author-level contributions, employment/COI and control-role materials for each trial" }, { "item_id": "N17", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Impaired vision harms · Follow-up", "needed": "Safety collection/denominators and observation scope in separate treatment trials", "role": "Supplementary", "role_reason": "Preparation item distinguishing Safety collection/denominators and observation scope in separate treatment trials to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Safety collection/denominators and observation scope in separate treatment trials must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on treatment outcomes and observed harms in each population; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ATC vascular events, intraocular pressure and possible visit-related detection bias in Protocol V are harm descriptions from a trial of different populations/strategies.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Harm definitions, collection/events/denominators, discontinuation/relatedness, visits/follow-up and vulnerable population materials in each impaired vision trial are unverified. No safety or established-harm certification is created. Content review remains incomplete.", "missingness": "Harm definitions, collection/events/denominators, discontinuation/relatedness, visits/follow-up and vulnerable population materials in each impaired vision trial are unverified. No safety or established-harm certification is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm populations, events/assessment/visits and follow-up materials for each trial" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Independent trials · Bibliography · Population relationships", "needed": "Mentioned trials/reports, actual populations/endpoints and independent replication", "role": "Required", "role_reason": "Preparation item distinguishing Mentioned trials/reports, actual populations/endpoints and independent replication to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Mentioned trials/reports, actual populations/endpoints and independent replication must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linkage is Chamgap's own application; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research distinguishing identical reports/populations from separate evidence; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing record describes benefits in separate trials, while the gap in direct reports remains. Names, arms/time points, the same people/eyes and sibling checklists are not arbitrarily summed to certify independent replication.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. Trial/registration/report relationships, participant/eye and endpoint-specific duplication/follow-up relationships and independence have not been compared with external originals. Content review remains incomplete.", "missingness": "Trial/registration/report relationships, participant/eye and endpoint-specific duplication/follow-up relationships and independence have not been compared with external originals.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct bibliography/registration, trial/population/endpoint relationships and separate replication materials" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Generalization to other vision, drugs/durations", "needed": "Application beyond the selected population, formulation and duration", "role": "Required", "role_reason": "Preparation item distinguishing Application beyond the selected population, formulation and duration to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Application beyond the selected population, formulation and duration must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.4; custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up research on the selected question and other conditions; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Treatment of diabetic macular edema with already impaired baseline vision is distinguished from an initial strategy in eyes with good vision. It is not extended to efficacy or null effects for all visual acuities, eye diseases, drugs or regimens.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. Exact specifications for each separate trial, other populations/drugs/durations and long-term vision/clinical outcomes/harms are unverified. No treatment selection or implementation guidance is created. Content review remains incomplete.", "missingness": "Exact specifications for each separate trial, other populations/drugs/durations and long-term vision/clinical outcomes/harms are unverified. No treatment selection or implementation guidance is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct materials by visual acuity/disease, drug/strategy and duration" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Original subclaim B · Parent D30/history", "needed": "Original subclaim values, parent axes/Korean-English text, dates/corrections and history", "role": "Required", "role_reason": "Preparation item distinguishing Original subclaim values, parent axes/Korean-English text, dates/corrections and history to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Original subclaim values, parent axes/Korean-English text, dates/corrections and history must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed update research distinguishing original material changes and production versions; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Subclaim B/note, parent D30/Caution, existing assessment axes/Korean-English text, 2026-08-26 and empty correction/deliberation values are preserved in the complete stored summary. Parent null-effect and out-of-scope subclaim descriptions are distinguished.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. Absent subclaim score/status/assessment axes and absent parent classification information are not filled. Historical cross-checks/registration/B0 and separate benefit descriptions are not new reading of originals, content review or independence certification. Content review remains incomplete.", "missingness": "Absent subclaim score/status/assessment axes and absent parent classification information are not filled. Historical cross-checks/registration/B0 and separate benefit descriptions are not new reading of originals, content review or independence certification.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict, corrected/changed text and user feedback" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Summary/links · Gap in direct materials", "needed": "Actual reading, URLs/identity and additional material scope for each material", "role": "Required", "role_reason": "Preparation item distinguishing Actual reading, URLs/identity and additional material scope for each material to connect materials needed for the selected question with the materials currently available.", "application_exception": "The scope preserves the selected impaired vision treatment’s existing B/note and separate trial mentions. The current gap in direct impaired vision bibliography/results remains; good-vision initial strategies, values, support and harms in Protocol V do not replace direct evidence for this treatment, and no new treatment or dosing guidance is created.", "criterion": "Original source materials and the relevant analysis scope for Actual reading, URLs/identity and additional material scope for each material must be available, and unresolved issues must be distinguishable. Here preserved wording is connected; content review remains incomplete.", "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose scoped update research based on materials actually acquired; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The stored summary and parent Protocol V bibliography/PMID 31037289 URL are connected. These do not replace direct stored summaries/bibliographic links for each impaired vision trial.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials are unread and content review is incomplete. Direct bibliography, papers/registrations/plans/disclosures for each separate trial and external Protocol V originals are unread; access has not been attempted. Link clicks or checks do not upgrade their status. Content review remains incomplete.", "missingness": "Direct bibliography, papers/registrations/plans/disclosures for each separate trial and external Protocol V originals are unread; access has not been attempted. Link clicks or checks do not upgrade their status.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reports/registrations/plans/disclosures for each direct trial and user comments" } ], "reports": [ { "report_id": "S01", "title": "Baker CW et al. 2019 DRCR Protocol V", "url": "https://pubmed.ncbi.nlm.nih.gov/31037289/", "report_type": "Three-arm multicenter randomized clinical trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2960-PROTOCOL-V", "independent_replication": null, "observed_result": "Preserved results in this report concern initial strategies in eyes with good vision: 16%/17%/19%; immediate injection versus observation RR 0.83 (95% CI 0.55–1.27), risk difference −3 percentage points (−11 to 4), P=0.79. These are not direct result values for the selected anti-VEGF treatment with already impaired vision. Only the existing B/note and textual description of benefit in separate trials are preserved; direct bibliography, population/intervention/comparator, endpoints/denominators and values/CIs remain unverified.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31037289/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Baker 2019/NCT01909791 Protocol V compares initial immediate aflibercept, laser and observation strategies for eyes with diabetic macular edema and vision of 20/25 or better. Distinguish 702 participants/702 eyes randomized at 91 sites (226/240/236) from two-year observed denominators (205/212/208). Preserve loss of at least five letters: 33/205 (16%), 36/212 (17%), 39/208 (19%), immediate versus observation RR 0.83 (0.55–1.27), original risk difference −3 percentage points (−11 to 4), P=.79. Controls include rescue aflibercept under prespecified worsening criteria; preserve observation 34%/laser 25% injection starts and about two thirds receiving no injection. Narrative mentions of benefits in already impaired vision at 20/50 or worse in VISTA/VIVID or Protocol T, and of Protocol W, concern other questions/trials without direct bibliographies/results here. Do not transfer the good-vision Protocol V effect/denominators to impaired-vision treatment. Do not add the same people/eyes, arms/sites, time points/injections, vision/harms, reports/registration or sibling sheets as new independent trials or participants. Report/material-slot counts are not totals of unique clinical trials, participants or independent replications; no new summation or independence certification is performed." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and materials were prepared from the existing 21 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }