{"type":"trials","record":{"id":28317,"source_id":"clinicaltrials-gov","external_id":"NCT07614776","title":"A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration","brief_summary":"The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)","overall_status":"Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Amgen","enrollment":304,"countries":["United States","Czechia","Japan","Latvia","Poland","Slovakia"],"start_date":"2026-05-27","completion_date":"2028-01-12","last_update_date":"2026-09-17","source_url":"https://clinicaltrials.gov/study/NCT07614776","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Recruiting. 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":null,"age_range":"50 Years","comparator":"Aflibercept (US) 8 mg","organization":"Amgen","interventions":["ABP 938 8 mg","Aflibercept (US) 8 mg"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score — Baseline…","Percentage of Participants With Absence of Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) in the Center Subfield,…","Change from Baseline in BCVA as measured by ETDRS letter score — Baseline to Week 48","Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24 — Baseline to Week 24","Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48 — Baseline to Week 48","Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA) — Base…","Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT — Baseline to Week 48","Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imag…","Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs) — Baseline up to Week 48","Number of Participants Who Experienced Non-Ocular TEAEs — Baseline up to Week 48","Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI) — Baseline up to Week 48","Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs) — Baseline up to Week 48","Number of Participants Who Developed Binding Antidrug Antibodies (ADAs) — Baseline up to Week 48","Free serum concentrations of ABP 938 8 mg — Week 16, week 24 and 48 (End of Study)","Free serum concentrations of Aflibercept (US) 8 mg — Week 16, week 24, and 48 (End of Study)","Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a…","Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","nAMD","ABP 938 8 mg","Aflibercept (US) 8 mg"],"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:nct07614776","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-05-27 to 2028-01-12","comparator":"Aflibercept (US) 8 mg","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":"2026-09-25T06:20:47.795Z","intervention":["ABP 938 8 mg","Aflibercept (US) 8 mg"],"participants":304,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","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 BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score — Baseline…","Percentage of Participants With Absence of Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) in the Center Subfield,…","Change from Baseline in BCVA as measured by ETDRS letter score — Baseline to Week 48","Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24 — Baseline to Week 24","Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48 — Baseline to Week 48","Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA) — Base…","Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT — Baseline to Week 48","Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imag…","Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs) — Baseline up to Week 48","Number of Participants Who Experienced Non-Ocular TEAEs — Baseline up to Week 48","Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI) — Baseline up to Week 48","Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs) — Baseline up to Week 48","Number of Participants Who Developed Binding Antidrug Antibodies (ADAs) — Baseline up to Week 48","Free serum concentrations of ABP 938 8 mg — Week 16, week 24 and 48 (End of Study)","Free serum concentrations of Aflibercept (US) 8 mg — Week 16, week 24, and 48 (End of Study)","Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a…","Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose…"],"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/28317","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}