{"type":"trials","record":{"id":28333,"source_id":"clinicaltrials-gov","external_id":"NCT04567303","title":"Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration","brief_summary":"This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD).","overall_status":"Completed","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":177,"countries":["United States","Puerto Rico"],"start_date":"2020-10-28","completion_date":"2026-08-25","last_update_date":"2026-09-14","source_url":"https://clinicaltrials.gov/study/NCT04567303","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.08831+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"BURGUNDY","age_range":"50 Years","comparator":"Part 3: PD With Ranibizumab","organization":"Hoffmann-La Roche","interventions":["Zifibancimig","Ranibizumab","Port Delivery Platform"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percentage of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) — Part 1: Baseline up to Week 24;…","Percentage of Participants With Ocular AEs During the Post-operative and Follow-up Periods — Parts 2 and 3: From Day 1…","Percentage of Participants With Adverse Events of Special Interest (AESIs) Including Ocular AESIs — Part 1: Baseline up…","Percentage of Participants With Ocular AESIs During the Post-operative and Follow-up Periods — Parts 2 and 3: From Day…","Duration of Ocular AESIs — Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 48","Duration of Ocular AESIs During the Post-operative and Follow-up Periods — Parts 2 and 3: From Day 1 to Week 4 and duri…","Percentage of Participants With Adverse Device Effects (ADEs) — Parts 2 and 3: Baseline up to Week 48","Duration of ADEs — Parts 2 and 3: Baseline up to Week 48","Percentage of Participants With Anticipated Serious ADEs (ASADEs) — Parts 2 and 3: Baseline up to Week 48","Duration of ASADEs — Parts 2 and 3: Baseline up to Week 48","Change From Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score at…","Maximum Observed Concentration (Cmax) of Zifibancimig in Blood and Aqueous Humor (AH) — Part 1: Baseline up to Week 24;…","Time of Maximum Concentration Observed (Tmax) of Zifibancimig in Blood and AH — Part 1: Baseline up to Week 24; Parts 2…","Concentration at the End of a Dosing Interval Before the Next Dose Administration (Ctrough) of Zifibancimig in Blood an…","Area Under the Curve (AUC) of Zifibancimig in Blood and AH — Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up…","Percentage of Participants Who did not Meet Supplemental Treatment Criteria for the PD Implant With Zifibancimig — Part…","Percentage of Participants Who Gained or Lost ≥15, ≥10 ≥5 or ≥0 Letters in ETDRS-BCVA Score From Baseline to Week 48 —…","Change From Baseline in Central Subfield Thickness (CST) at Week 48 — Part 3: Baseline, and Week 48","Change From Baseline Over Time in CST — Part 3: Baseline to end of follow-up period (up to Week 144)"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Macular Degeneration","Zifibancimig","Ranibizumab","Port Delivery Platform"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"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:nct04567303","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-10-28 to 2026-08-25","comparator":"Part 3: PD With Ranibizumab","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":"2026-09-25T06:20:47.798Z","intervention":["Zifibancimig","Ranibizumab","Port Delivery Platform"],"participants":177,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, PHASE2","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":["Percentage of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) — Part 1: Baseline up to Week 24;…","Percentage of Participants With Ocular AEs During the Post-operative and Follow-up Periods — Parts 2 and 3: From Day 1…","Percentage of Participants With Adverse Events of Special Interest (AESIs) Including Ocular AESIs — Part 1: Baseline up…","Percentage of Participants With Ocular AESIs During the Post-operative and Follow-up Periods — Parts 2 and 3: From Day…","Duration of Ocular AESIs — Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 48","Duration of Ocular AESIs During the Post-operative and Follow-up Periods — Parts 2 and 3: From Day 1 to Week 4 and duri…","Percentage of Participants With Adverse Device Effects (ADEs) — Parts 2 and 3: Baseline up to Week 48","Duration of ADEs — Parts 2 and 3: Baseline up to Week 48","Percentage of Participants With Anticipated Serious ADEs (ASADEs) — Parts 2 and 3: Baseline up to Week 48","Duration of ASADEs — Parts 2 and 3: Baseline up to Week 48","Change From Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score at…","Maximum Observed Concentration (Cmax) of Zifibancimig in Blood and Aqueous Humor (AH) — Part 1: Baseline up to Week 24;…","Time of Maximum Concentration Observed (Tmax) of Zifibancimig in Blood and AH — Part 1: Baseline up to Week 24; Parts 2…","Concentration at the End of a Dosing Interval Before the Next Dose Administration (Ctrough) of Zifibancimig in Blood an…","Area Under the Curve (AUC) of Zifibancimig in Blood and AH — Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up…","Percentage of Participants Who did not Meet Supplemental Treatment Criteria for the PD Implant With Zifibancimig — Part…","Percentage of Participants Who Gained or Lost ≥15, ≥10 ≥5 or ≥0 Letters in ETDRS-BCVA Score From Baseline to Week 48 —…","Change From Baseline in Central Subfield Thickness (CST) at Week 48 — Part 3: Baseline, and Week 48","Change From Baseline Over Time in CST — Part 3: Baseline to end of follow-up period (up to Week 144)"],"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.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","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/28333","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}