{"type":"trials","record":{"id":41891,"source_id":"clinicaltrials-gov","external_id":"NCT05672121","title":"Safety and Tolerability of KH631 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)","brief_summary":"KH631 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.","overall_status":"Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Chengdu Origen Biotechnology Co., Ltd.","enrollment":42,"countries":["China"],"start_date":"2023-02-06","completion_date":"2026-12-28","last_update_date":"2024-11-27","source_url":"https://clinicaltrials.gov/study/NCT05672121","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":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"50 Years to 85 Years","comparator":null,"organization":"Chengdu Kanghong Pharmaceutical Group Co., Ltd.","interventions":["KH631"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Safety — 24 weeks","Change in best corrected visual acuity — 52 weeks","Safety — 104 weeks","Change in best corrected visual acuity — 104 weeks","Change in central retinal thickness — 104 weeks","Change in area of retinal leakage — 104 weeks","Rescue injections — 104 weeks"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","KH631"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct05672121","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-02-06 to 2026-12-28","comparator":null,"confidence":"structured-source","population":"ALL · 50 Years to 85 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":"2026-09-25T06:20:47.887Z","intervention":["KH631"],"participants":42,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","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":["Safety — 24 weeks","Change in best corrected visual acuity — 52 weeks","Safety — 104 weeks","Change in best corrected visual acuity — 104 weeks","Change in central retinal thickness — 104 weeks","Change in area of retinal leakage — 104 weeks","Rescue injections — 104 weeks"],"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/41891","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}