{"type":"trials","record":{"id":28298,"source_id":"clinicaltrials-gov","external_id":"NCT07215234","title":"A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","brief_summary":"This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase. The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).","overall_status":"Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Sanofi","enrollment":104,"countries":["United States","Australia","United Kingdom"],"start_date":"2025-10-09","completion_date":"2032-07-22","last_update_date":"2026-09-22","source_url":"https://clinicaltrials.gov/study/NCT07215234","editorial_summary":"A registered PHASE1, PHASE2 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":"60 Years","comparator":null,"organization":"Sanofi","interventions":["SAR446597","Sham Comparator"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) — Day 1 to Week 104","Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs) — Day 1 to Week 104","Change in square root-transformed (mm) and untransformed area (mm2) of GA — Baseline, Week 52, Week 104","Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration…","Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye — Baseline, Week 52…","Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety par…"],"design_description":"RANDOMIZED · SEQUENTIAL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Geographic Atrophy","SAR446597","Sham Comparator"],"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:nct07215234","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-10-09 to 2032-07-22","comparator":null,"confidence":"structured-source","population":"ALL · 60 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":"2026-09-25T06:20:47.791Z","intervention":["SAR446597","Sham Comparator"],"participants":104,"study_design":"RANDOMIZED · SEQUENTIAL · TREATMENT · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, 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":["Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) — Day 1 to Week 104","Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs) — Day 1 to Week 104","Change in square root-transformed (mm) and untransformed area (mm2) of GA — Baseline, Week 52, Week 104","Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration…","Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye — Baseline, Week 52…","Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety par…"],"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.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","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/28298","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}