{"type":"trials","record":{"id":42110,"source_id":"clinicaltrials-gov","external_id":"NCT03748784","title":"ADVM-022 Intravitreal Gene Therapy for Wet AMD","brief_summary":"ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Adverum Biotechnologies, Inc.","enrollment":30,"countries":["United States"],"start_date":"2018-11-14","completion_date":"2022-06-22","last_update_date":"2023-08-08","source_url":"https://clinicaltrials.gov/study/NCT03748784","editorial_summary":"A registered PHASE1 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":"OPTIC","age_range":"50 Years","comparator":null,"organization":"Adverum Biotechnologies, Inc.","interventions":["ADVM-022"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Type, severity, and incidence of ocular and systemic adverse events (AEs) — 104 weeks","Change in best corrected visual acuity (BCVA) — 104 weeks","Change in central subfield thickness (CST) and macular volume measured by SD-OCT — 104 weeks","Percentage of subjects requiring anti-VEGF injections over time — 104 weeks","Mean number of anti-VEGF injections over time — 104 weeks","Percentage of subjects without intraretinal fluid over time — 104 weeks","Percentage of subjects without subretinal fluid over time — 104 weeks"],"design_description":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Wet Age-related Macular Degeneration","Neovascular Age-related Macular Degeneration","ADVM-022"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct03748784","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-11-14 to 2022-06-22","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":"2026-09-25T06:20:47.921Z","intervention":["ADVM-022"],"participants":30,"study_design":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1","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":["Type, severity, and incidence of ocular and systemic adverse events (AEs) — 104 weeks","Change in best corrected visual acuity (BCVA) — 104 weeks","Change in central subfield thickness (CST) and macular volume measured by SD-OCT — 104 weeks","Percentage of subjects requiring anti-VEGF injections over time — 104 weeks","Mean number of anti-VEGF injections over time — 104 weeks","Percentage of subjects without intraretinal fluid over time — 104 weeks","Percentage of subjects without subretinal fluid over time — 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":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related, elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/42110","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}