{"type":"trials","record":{"id":41517,"source_id":"clinicaltrials-gov","external_id":"NCT06856577","title":"Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration","brief_summary":"This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to an active comparator. The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured at an average of Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.","overall_status":"Active Not Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Adverum Biotechnologies, Inc.","enrollment":311,"countries":["United States"],"start_date":"2025-02-28","completion_date":"2030-11-23","last_update_date":"2026-05-22","source_url":"https://clinicaltrials.gov/study/NCT06856577","editorial_summary":"A registered PHASE3 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":"ARTEMIS","age_range":"50 Years","comparator":"Aflibercept","organization":"Adverum Biotechnologies, Inc.","interventions":["Ixo-vec","Aflibercept"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean change from Baseline in Best-Corrected Visual Acuity (BCVA) based on an average at Weeks 52 and 56 — Baseline, Wee…","Mean number of aflibercept IVT injections received — Week 4 through Week 56","Percentage of participants with worsened BCVA from Baseline through Week 56 and Week 104 — Baseline through Week 56 and…","Percentage of participants with improved BCVA from Baseline through Week 56 and Week 104 — Baseline through Week 56 and…","Mean change from Baseline in BCVA through Week 104 — Baseline through Week 104","Mean change from Week 1 in BCVA based on an average at Weeks 52 and 56 and at Week 104 — Week 1 to Week 56 and Week 104","Percentage of participants with BCVA of 73 letters or more from Week 4 through Week 56 and Week 104 — Week 4 through We…","Mean change in Central Subfield Thickness (CST) from Baseline to Week 56 and Week 104 — Baseline to Week 56 and Week 104","Percentage of participants with CST ≤ 300 μm at Week 56 and Week 104 — Week 56 and Week 104","Mean number of CST fluctuations > 50 μm from Week 1 through Week 56 and Week 104 — Week 1 through Week 56 and Week 104","Percentage of participants with CST fluctuations > 50 μm from Week 1 through Week 56 and Week 104 — Week 1 through Week…","Mean number of aflibercept IVT injections received from Week 4 through Week 104 — Week 4 through Week 104","Percent reduction in mean rate of annualized anti-Vascular Endothelial Growth Factor (VEGF) injections after 56 weeks a…","Percentage of participants who were aflibercept injection-free — Week 4 through Week 56 and through Week 104","Percentage of participants who received 0 or 1 aflibercept injection — Week 4 through Week 56 and through Week 104","Percentage of participants who receive 0, 1, or 2 aflibercept injections from Week 4 through Week 56 and through Week 1…","Mean change in area of Choroidal Neovascularization (CNV) lesion from Baseline through Week 104 — Baseline through Week…","Mean change in macular volume from Baseline through Week 104 — Baseline through Week 104","Percentage of participants without Intraretinal Fluid (IRF) through Week 104 — Through Week 104","Percentage of participants without Subretinal Fluid (SRF) through Week 104 — Through Week 104"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Neovascular Age-Related Macular Degeneration (nAMD)","Wet AMD","Ixo-vec","Aflibercept"],"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:nct06856577","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-02-28 to 2030-11-23","comparator":"Aflibercept","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":"2026-09-25T06:20:47.826Z","intervention":["Ixo-vec","Aflibercept"],"participants":311,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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":["Mean change from Baseline in Best-Corrected Visual Acuity (BCVA) based on an average at Weeks 52 and 56 — Baseline, Wee…","Mean number of aflibercept IVT injections received — Week 4 through Week 56","Percentage of participants with worsened BCVA from Baseline through Week 56 and Week 104 — Baseline through Week 56 and…","Percentage of participants with improved BCVA from Baseline through Week 56 and Week 104 — Baseline through Week 56 and…","Mean change from Baseline in BCVA through Week 104 — Baseline through Week 104","Mean change from Week 1 in BCVA based on an average at Weeks 52 and 56 and at Week 104 — Week 1 to Week 56 and Week 104","Percentage of participants with BCVA of 73 letters or more from Week 4 through Week 56 and Week 104 — Week 4 through We…","Mean change in Central Subfield Thickness (CST) from Baseline to Week 56 and Week 104 — Baseline to Week 56 and Week 104","Percentage of participants with CST ≤ 300 μm at Week 56 and Week 104 — Week 56 and Week 104","Mean number of CST fluctuations > 50 μm from Week 1 through Week 56 and Week 104 — Week 1 through Week 56 and Week 104","Percentage of participants with CST fluctuations > 50 μm from Week 1 through Week 56 and Week 104 — Week 1 through Week…","Mean number of aflibercept IVT injections received from Week 4 through Week 104 — Week 4 through Week 104","Percent reduction in mean rate of annualized anti-Vascular Endothelial Growth Factor (VEGF) injections after 56 weeks a…","Percentage of participants who were aflibercept injection-free — Week 4 through Week 56 and through Week 104","Percentage of participants who received 0 or 1 aflibercept injection — Week 4 through Week 56 and through Week 104","Percentage of participants who receive 0, 1, or 2 aflibercept injections from Week 4 through Week 56 and through Week 1…","Mean change in area of Choroidal Neovascularization (CNV) lesion from Baseline through Week 104 — Baseline through Week…","Mean change in macular volume from Baseline through Week 104 — Baseline through Week 104","Percentage of participants without Intraretinal Fluid (IRF) through Week 104 — Through Week 104","Percentage of participants without Subretinal Fluid (SRF) through Week 104 — Through Week 104"],"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/41517","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}