{"type":"trials","record":{"id":41456,"source_id":"clinicaltrials-gov","external_id":"NCT06660667","title":"A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration","brief_summary":"This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration. Participants will be enrolled in one of 2 parts: * In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants * In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants, investigators and outcomes assessors will be masked to dose. After receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5.","overall_status":"Active Not Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Sanofi","enrollment":66,"countries":["United States","United Kingdom"],"start_date":"2024-11-21","completion_date":"2031-06-30","last_update_date":"2026-07-16","source_url":"https://clinicaltrials.gov/study/NCT06660667","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. 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 to 90 Years","comparator":null,"organization":"Sanofi","interventions":["SAR402663","Diluent"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence and severity of ocular treatment emergent adverse event (TEAEs) — Day 1 to Week 52","Incidence and severity of ocular treatment emergent serious adverse event (TESAEs) — Day 1 to Week 52","Incidence and severity of non-ocular TEAEs — Day 1 to Week 52","Incidence and severity of non-ocular TESAEs — Day 1 to Week 52","Number of participants with any clinically significant changes in laboratory variables — Day 1 to Week 52","Number of participants with any clinically significant changes in vital signs — Day 1 to Week 52","Percentage of participants not requiring supplemental anti- vascular endothelial growth factor (VEGF) therapy — Day 1 t…","Annualized injection rates of anti-VEGF therapy — Day 1 to Week 52","Change from baseline in BCVA using the ETDRS letter score — Baseline, Week 52","Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline — Baseline, Week 52","Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-…"],"design_description":"RANDOMIZED · SEQUENTIAL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","SAR402663","Diluent"],"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:nct06660667","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-11-21 to 2031-06-30","comparator":null,"confidence":"structured-source","population":"ALL · 50 Years to 90 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":"2026-09-25T06:20:47.816Z","intervention":["SAR402663","Diluent"],"participants":66,"study_design":"RANDOMIZED · SEQUENTIAL · TREATMENT · QUADRUPLE","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 treatment emergent adverse event (TEAEs) — Day 1 to Week 52","Incidence and severity of ocular treatment emergent serious adverse event (TESAEs) — Day 1 to Week 52","Incidence and severity of non-ocular TEAEs — Day 1 to Week 52","Incidence and severity of non-ocular TESAEs — Day 1 to Week 52","Number of participants with any clinically significant changes in laboratory variables — Day 1 to Week 52","Number of participants with any clinically significant changes in vital signs — Day 1 to Week 52","Percentage of participants not requiring supplemental anti- vascular endothelial growth factor (VEGF) therapy — Day 1 t…","Annualized injection rates of anti-VEGF therapy — Day 1 to Week 52","Change from baseline in BCVA using the ETDRS letter score — Baseline, Week 52","Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline — Baseline, Week 52","Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-…"],"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/41456","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}