{"type":"trials","record":{"id":42179,"source_id":"clinicaltrials-gov","external_id":"NCT05587062","title":"Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration","brief_summary":"The purpose of this study is to evaluate the efficacy and safety of Aflibercept (produced by CinnaGen Co, Iran) compared with Eylea® (Regeneron, USA) in subjects with Neovascular Age-related Macular Degeneration (nAMD). All the participants will receive one of the following regimens: Aflibercept (CinnaGen Co, Iran) or Eylea® (Regeneron, USA), 2 mg (vial 0.05 ml) by intravitreal injection every 4 weeks for the first 3 injections, followed by 2 mg every 8 weeks until week 48 of study. The primary objective of this study is to verify the non-inferiority of Aflibercept (CinnaGen Co, Iran) versus Eylea® (Regeneron, USA) in achieving maintaining vision (losing\\<15 letter on ETDRS chart) at week 52 in comparison to week 0 in participants with Neovascular AMD.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Cinnagen","enrollment":168,"countries":["Iran"],"start_date":"2019-10-01","completion_date":"2022-07-31","last_update_date":"2023-02-14","source_url":"https://clinicaltrials.gov/study/NCT05587062","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":"55 Years to 80 Years","comparator":"Aflibercept (Regeneron, USA)","organization":"Cinnagen","interventions":["Aflibercept (CinnaGen Co, Iran)","Aflibercept (Regeneron, USA)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The proportion of patients achieving maintaining vision at week 52 — At week 52","Mean changes in the Best-Corrected Visual Acuity Index from week 0 to week 52 — Baseline and at week 52","The percentage of patients who have increase of ≥15 score in ETDRS at week 52 compared to week 0 — Baseline and at week…","The mean change in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) at week 52 compared to week 0 — Ba…","Mean changes in central retinal thickness at week 52 compared to the screening visit — Baseline and at week 52","The percentage of patients without intra-retinal fluid and subretinal fluid at week 52 — Baseline and at week 52","Number of participants with Adverse Events (AEs) — Baseline up to Week 52"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","Neovascular Age-related Macular Degeneration","Aflibercept (CinnaGen Co, Iran)","Aflibercept (Regeneron, USA)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"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:nct05587062","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-10-01 to 2022-07-31","comparator":"Aflibercept (Regeneron, USA)","confidence":"structured-source","population":"ALL · 55 Years to 80 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":"2026-09-25T06:20:47.931Z","intervention":["Aflibercept (CinnaGen Co, Iran)","Aflibercept (Regeneron, USA)"],"participants":168,"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":["The proportion of patients achieving maintaining vision at week 52 — At week 52","Mean changes in the Best-Corrected Visual Acuity Index from week 0 to week 52 — Baseline and at week 52","The percentage of patients who have increase of ≥15 score in ETDRS at week 52 compared to week 0 — Baseline and at week…","The mean change in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) at week 52 compared to week 0 — Ba…","Mean changes in central retinal thickness at week 52 compared to the screening visit — Baseline and at week 52","The percentage of patients without intra-retinal fluid and subretinal fluid at week 52 — Baseline and at week 52","Number of participants with Adverse Events (AEs) — Baseline up to Week 52"],"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/42179","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}