{"type":"trials","record":{"id":87111,"source_id":"isrctn","external_id":"ISRCTN42621450","title":"Study to assess safety and efficacy of ADVM-022 in patients having already received anti-VEGF treatment for neovascular (wet) age-related macular degeneration (nAMD) [LUNA]","brief_summary":"Primary objective: To assess the safety, tolerability, and efficacy of a single intravitreal (IVT) injection of ADVM-022 in anti-VEGF treatment-experienced patients with neovascular (wet) age-related macular degeneration (nAMD) Secondary objectives: 1. To evaluate the effect of ADVM-022 on best corrected visual acuity (BCVA) using an an early treatment diabetic retinopathy study (ETDRS) visual acuity chart 2. To assess the durability of a single IVT injection of ADVM-022 3. To evaluate the effect of ADVM 022 on Central Subfield Thickness (CST) 4. To assess the effectiveness of prophylactic corticosteroid treatment regimens on minimizing post-prophylactic inflammation events","overall_status":"Completed","phases":[],"study_type":"Interventional","sponsor":"Adverum Biotechnologies Inc","enrollment":72,"countries":["United Kingdom","France","United States of America"],"start_date":"2022-08-23","completion_date":"2024-02-26","last_update_date":"2022-11-01","source_url":"https://www.isrctn.com/ISRCTN42621450","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T03:46:39.792962+00:00","last_seen_at":"2026-09-25T03:46:39.551+00:00","metadata":{"sex":"All","age_range":"Mixed","comparator":null,"attribution":"Source: ISRCTN ISRCTN42621450; retrieved 2026-09-25","interventions":["Genetic"],"reuse_license":"Registry contribution CC BY 4.0; generated metadata CC0","registry_source":"ISRCTN","outcome_measures":["1. Incidence and severity of ocular and non-ocular adverse events from baseline through Week 50 2. Mean change in BCVA…","1. Percentage of participants who lose/gain at least 5, 10 or 15 letters in BCVA using an ETDRS visual acuity chart com…"],"design_description":"Interventional","source_has_results":false},"controlled_terms":["Neovascular (wet) age-related macular degeneration","For experimental arm dose 1, a single intravitreal injection of ADVM-022 2E11 vg/eye. The treatment is a single IVT inj…","Genetic"],"relevance_confidence":100,"source_quality_score":98,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T03:46:42.633202+00:00","duplicate_cluster_key":"id:isrctn42621450","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-08-23 to 2024-02-26","comparator":null,"confidence":"structured-source","population":"All · Mixed","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":"2026-09-25T03:46:39.563Z","intervention":["Genetic"],"participants":72,"study_design":"Interventional","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","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":["1. Incidence and severity of ocular and non-ocular adverse events from baseline through Week 50 2. Mean change in BCVA…","1. Percentage of participants who lose/gain at least 5, 10 or 15 letters in BCVA using an ETDRS visual acuity chart com…"],"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":"ISRCTN Registry","homepage_url":"https://www.isrctn.com/"}},"canonical_url":"https://www.immortal.life/trials/87111","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}