{"type":"trials","record":{"id":42214,"source_id":"clinicaltrials-gov","external_id":"NCT04684394","title":"A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration","brief_summary":"This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.","overall_status":"Terminated","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Gemini Therapeutics, Inc.","enrollment":50,"countries":["United States"],"start_date":"2020-12-29","completion_date":"2022-02-18","last_update_date":"2022-10-31","source_url":"https://clinicaltrials.gov/study/NCT04684394","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Terminated. 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":null,"organization":"Gemini Therapeutics, Inc.","interventions":["GEM103","Aflibercept","Sham"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) — Baseline up to Week 48","Number of Participants With Non-ocular TEAEs — Baseline up to Week 48","Number of Participants With Abnormal Ophthalmic Examination Findings — Baseline up to Week 48","Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected…","Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance V…","Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48 — Baseline, Week 48","Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor — Baseline, Week 32","Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA)…","Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF) — Baseline up to Week 48"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration","Retinal Disease","Retinal Degeneration","Macular Degeneration","GEM103","Aflibercept","Sham"],"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:nct04684394","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-12-29 to 2022-02-18","comparator":null,"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":"2026-09-25T06:20:47.936Z","intervention":["GEM103","Aflibercept","Sham"],"participants":50,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"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":["Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) — Baseline up to Week 48","Number of Participants With Non-ocular TEAEs — Baseline up to Week 48","Number of Participants With Abnormal Ophthalmic Examination Findings — Baseline up to Week 48","Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected…","Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance V…","Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48 — Baseline, Week 48","Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor — Baseline, Week 32","Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA)…","Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF) — Baseline up to Week 48"],"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/42214","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}