{"type":"trials","record":{"id":42043,"source_id":"clinicaltrials-gov","external_id":"NCT04450329","title":"A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)","brief_summary":"This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Samsung Bioepis Co., Ltd.","enrollment":449,"countries":["United States","Croatia","Czechia","Estonia","Hungary","Japan","Latvia","Poland","Russia","South Korea"],"start_date":"2020-06-23","completion_date":"2022-03-16","last_update_date":"2024-02-05","source_url":"https://clinicaltrials.gov/study/NCT04450329","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":null,"age_range":"50 Years","comparator":"Eylea (Aflibercept)","organization":"Samsung Bioepis Co., Ltd.","interventions":["SB15 (Proposed aflibercept biosimilar)","Eylea (Aflibercept)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change From Baseline in Best Corrected Visual Acuity (BCVA) — Baseline and Week 8"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration","SB15 (Proposed aflibercept biosimilar)","Eylea (Aflibercept)"],"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:nct04450329","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-06-23 to 2022-03-16","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":"2026-09-25T06:20:47.911Z","intervention":["SB15 (Proposed aflibercept biosimilar)","Eylea (Aflibercept)"],"participants":449,"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":["Change From Baseline in Best Corrected Visual Acuity (BCVA) — Baseline and Week 8"],"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/42043","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}