{"type":"trials","record":{"id":28291,"source_id":"clinicaltrials-gov","external_id":"NCT07482176","title":"Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)","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 intravitreal aflibercept (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 as an average at Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.","overall_status":"Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Adverum Biotechnologies, Inc.","enrollment":534,"countries":["United States"],"start_date":"2026-03-16","completion_date":"2031-10-20","last_update_date":"2026-09-24","source_url":"https://clinicaltrials.gov/study/NCT07482176","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.08831+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"AQUARIUS","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 BCVA Based on an Average at Weeks 52 and 56 — Baseline, Week 52 and Week 56","Mean Number of Aflibercept IVT Injections Received — Week 4 through Week 56","Percentage of Participants with Worsened BCVA — Through Week 56","Percentage of Participants with Improved BCVA — Through Week 56","Mean Change from Baseline in BCVA Over Time Based on an Average at Weeks 52 and 56 — Baseline Through Week 56","Mean Change from Week 1 in BCVA Based on an Average at Weeks 52 and 56 — Week 1 through Week 56","Percentage of Participants with BCVA of 73 Letters or More from Week 4 Through Week 56 — Week 4 through Week 56","Mean Change in Central Subfield Thickness (CST) from Baseline Over Time Through Week 56 — Baseline Through Week 56","Percentage of Participants with CST ≤ 300 μm Over Time Through Week 56 — Through Week 56","Mean Number of CST Fluctuations > 50 μm From Week 1 Over Time Through Week 56 — Week 1 through Week 56","Percentage of Participants with CST Fluctuations > 50 μm from Week 1 Over Time Through Week 56 — Week 1 through Week 56","Percent Reduction in Mean Rate of Annualized Anti-VEGF Injections — Through Week 56","Percentage of Participants Who Were Aflibercept Injection-free — Week 4 through Week 56","Percentage of Participants Who Received 0 or 1 Aflibercept Injection — Week 4 through Week 56","Mean Change in Area of Choroidal Neovascularization (CNV) Lesion from Baseline Over Time Through Week 56 — Baseline thr…","Mean Change in Macular Volume from Baseline Over Time Through Week 56 — Baseline through Week 56","Percentage of Participants Without Intraretinal Fluid (IRF) Over Time Through Week 56 — Through Week 56","Percentage of Participants Without Subretinal Fluid (SRF) Over Time Through Week 56 — Through Week 56","Percentage of Participants Without IRF and/or SRF Over Time Through Week 56 — Through Week 56","Time to Dry Retina — Through Week 56"],"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:nct07482176","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-03-16 to 2031-10-20","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":"2026-09-25T06:20:47.789Z","intervention":["Ixo-vec","Aflibercept"],"participants":534,"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 BCVA Based on an Average at Weeks 52 and 56 — Baseline, Week 52 and Week 56","Mean Number of Aflibercept IVT Injections Received — Week 4 through Week 56","Percentage of Participants with Worsened BCVA — Through Week 56","Percentage of Participants with Improved BCVA — Through Week 56","Mean Change from Baseline in BCVA Over Time Based on an Average at Weeks 52 and 56 — Baseline Through Week 56","Mean Change from Week 1 in BCVA Based on an Average at Weeks 52 and 56 — Week 1 through Week 56","Percentage of Participants with BCVA of 73 Letters or More from Week 4 Through Week 56 — Week 4 through Week 56","Mean Change in Central Subfield Thickness (CST) from Baseline Over Time Through Week 56 — Baseline Through Week 56","Percentage of Participants with CST ≤ 300 μm Over Time Through Week 56 — Through Week 56","Mean Number of CST Fluctuations > 50 μm From Week 1 Over Time Through Week 56 — Week 1 through Week 56","Percentage of Participants with CST Fluctuations > 50 μm from Week 1 Over Time Through Week 56 — Week 1 through Week 56","Percent Reduction in Mean Rate of Annualized Anti-VEGF Injections — Through Week 56","Percentage of Participants Who Were Aflibercept Injection-free — Week 4 through Week 56","Percentage of Participants Who Received 0 or 1 Aflibercept Injection — Week 4 through Week 56","Mean Change in Area of Choroidal Neovascularization (CNV) Lesion from Baseline Over Time Through Week 56 — Baseline thr…","Mean Change in Macular Volume from Baseline Over Time Through Week 56 — Baseline through Week 56","Percentage of Participants Without Intraretinal Fluid (IRF) Over Time Through Week 56 — Through Week 56","Percentage of Participants Without Subretinal Fluid (SRF) Over Time Through Week 56 — Through Week 56","Percentage of Participants Without IRF and/or SRF Over Time Through Week 56 — Through Week 56","Time to Dry Retina — Through Week 56"],"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/28291","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}