{"type":"trials","record":{"id":41681,"source_id":"clinicaltrials-gov","external_id":"NCT04522167","title":"Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration","brief_summary":"This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Bioeq GmbH","enrollment":434,"countries":["Bulgaria","Czechia","Hungary","Israel","Italy","Japan","Poland","Russia","Ukraine"],"start_date":"2020-07-21","completion_date":"2023-05-18","last_update_date":"2025-11-13","source_url":"https://clinicaltrials.gov/study/NCT04522167","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":"MAGELLAN-AMD","age_range":"50 Years","comparator":"Eylea® (Aflibercept)","organization":"Bioeq GmbH","interventions":["FYB203 (Proposed aflibercept biosimilar)","Eylea® (Aflibercept)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy…","Evaluate and Compare Functional Changes of the Retina by BCVA Over Time — Through study completion, until Week 56 (Visi…","Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness — Through study completion, until Week 56 (…","Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy S…","Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time — Through study completion, until We…","Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm) — A…","Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Func…","Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum — Through study completion, until W…","Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) — Through study completion, unti…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration","FYB203 (Proposed aflibercept biosimilar)","Eylea® (Aflibercept)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct04522167","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-07-21 to 2023-05-18","comparator":"Eylea® (Aflibercept)","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":"2026-09-25T06:20:47.852Z","intervention":["FYB203 (Proposed aflibercept biosimilar)","Eylea® (Aflibercept)"],"participants":434,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","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":["Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy…","Evaluate and Compare Functional Changes of the Retina by BCVA Over Time — Through study completion, until Week 56 (Visi…","Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness — Through study completion, until Week 56 (…","Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy S…","Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time — Through study completion, until We…","Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm) — A…","Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Func…","Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum — Through study completion, until W…","Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) — Through study completion, unti…"],"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.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","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/41681","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}