{"type":"trials","record":{"id":41967,"source_id":"clinicaltrials-gov","external_id":"NCT04964089","title":"A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)","brief_summary":"This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Kodiak Sciences Inc","enrollment":557,"countries":["United States","Puerto Rico"],"start_date":"2021-06-23","completion_date":"2023-04-06","last_update_date":"2024-07-03","source_url":"https://clinicaltrials.gov/study/NCT04964089","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"DAYLIGHT","age_range":"50 Years","comparator":"Aflibercept (Treatment Group B)","organization":"Kodiak Sciences Inc","interventions":["KSI-301","Aflibercept","Sham Procedure"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44…","Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time — Day 1 to Week 48","Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time — Day 1 to Week 48","Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time — Day 1 to Week 48","Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) — Day 1 to Wee…","Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) — Day 1 to Wee…","Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Ove…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":true},"controlled_terms":["Wet Age-related Macular Degeneration","KSI-301","Aflibercept","Sham Procedure"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04964089","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-06-23 to 2023-04-06","comparator":"Aflibercept (Treatment Group B)","confidence":"structured-source","population":"ALL · 50 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.901Z","intervention":["KSI-301","Aflibercept","Sham Procedure"],"participants":557,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44…","Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time — Day 1 to Week 48","Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time — Day 1 to Week 48","Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time — Day 1 to Week 48","Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) — Day 1 to Wee…","Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) — Day 1 to Wee…","Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Ove…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41967","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}