{"type":"trials","record":{"id":41735,"source_id":"clinicaltrials-gov","external_id":"NCT05536973","title":"Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]","brief_summary":"Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.","overall_status":"Active Not Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Adverum Biotechnologies, Inc.","enrollment":69,"countries":["United States","France","United Kingdom"],"start_date":"2022-08-23","completion_date":"2028-08-01","last_update_date":"2025-08-22","source_url":"https://clinicaltrials.gov/study/NCT05536973","editorial_summary":"A registered 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","comparator":null,"organization":"Adverum Biotechnologies, Inc.","interventions":["ADVM-022"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence of ocular and non-ocular adverse events — Up to Week 52","Severity of ocular and non-ocular adverse events — Up to Week 52","Mean change in best corrected visual acuity (BCVA) from Baseline — Baseline up to Week 52","Percentage of participants from Baseline who lose/gain at least 5, 10 or 15 letters in BCVA — Baseline up to 5 years","Mean change in BCVA from Baseline — Baseline up to 5 years","Percentage of participants who are supplemental aflibercept injection-free — Baseline up to 5 years","Percent reduction in annualized anti-VEGF injections — Baseline up to 5 years","Mean change in Central Subfield Thickness (CST) from Baseline — Baseline up to 5 years","Percentage of participants without CST fluctuations — Baseline up to 5 years","Mean number of CST fluctuations from Baseline — Baseline up to 5 years","Percentage of participants without post-prophylactic inflammation — Baseline up to 5 years","Incidence of ocular and non-ocular adverse events — Up to 60 months","Severity of ocular and non-ocular adverse events — Up to 60 months"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","ADVM-022"],"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:nct05536973","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-08-23 to 2028-08-01","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":"2026-09-25T06:20:47.862Z","intervention":["ADVM-022"],"participants":69,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","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":["Incidence of ocular and non-ocular adverse events — Up to Week 52","Severity of ocular and non-ocular adverse events — Up to Week 52","Mean change in best corrected visual acuity (BCVA) from Baseline — Baseline up to Week 52","Percentage of participants from Baseline who lose/gain at least 5, 10 or 15 letters in BCVA — Baseline up to 5 years","Mean change in BCVA from Baseline — Baseline up to 5 years","Percentage of participants who are supplemental aflibercept injection-free — Baseline up to 5 years","Percent reduction in annualized anti-VEGF injections — Baseline up to 5 years","Mean change in Central Subfield Thickness (CST) from Baseline — Baseline up to 5 years","Percentage of participants without CST fluctuations — Baseline up to 5 years","Mean number of CST fluctuations from Baseline — Baseline up to 5 years","Percentage of participants without post-prophylactic inflammation — Baseline up to 5 years","Incidence of ocular and non-ocular adverse events — Up to 60 months","Severity of ocular and non-ocular adverse events — Up to 60 months"],"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/41735","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}