{"type":"trials","record":{"id":41430,"source_id":"clinicaltrials-gov","external_id":"NCT07630649","title":"Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration","brief_summary":"The purpose of this study is to evaluate safety, effectiveness and durability of a gene therapy called Ixo-vec (Ixoberogene soroparvovec) when administered to the contralateral (second) eye of adult participants (≥ 50 years of age) who have been diagnosed with bilateral neovascular (wet) age related macular degeneration (nAMD). The study will enroll adults with nAMD in both eyes, including participants who previously received Ixo-vec treatment in one (initial) eye and/or participants who will receive Ixo-vec treatment for the first time. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye. Participants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy. The study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.","overall_status":"Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Adverum Biotechnologies, Inc.","enrollment":15,"countries":["United States"],"start_date":"2026-06-02","completion_date":"2031-06-01","last_update_date":"2026-08-05","source_url":"https://clinicaltrials.gov/study/NCT07630649","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: 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":["Ixo-vec"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence of ocular adverse events (AEs) — Baseline through Week 28","Incidence of ocular serious adverse events (SAEs). — Baseline through Week 28","Incidence of non-ocular serious adverse events (SAEs). — Baseline through Week 28","Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28. — Baseline through Week 28","Mean change from baseline in central subfield thickness (CST) over time through Week 28. — Baseline through Week 28","Mean number of supplemental aflibercept IVT injections received from Week 4 through Week 28 — Week 4 through Week 28","Percentage of participants who are supplemental aflibercept injection-free through Week 28. — Baseline through Week 28"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD","Ixo-vec"],"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:nct07630649","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-06-02 to 2031-06-01","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":"2026-09-25T06:20:47.810Z","intervention":["Ixo-vec"],"participants":15,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","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 adverse events (AEs) — Baseline through Week 28","Incidence of ocular serious adverse events (SAEs). — Baseline through Week 28","Incidence of non-ocular serious adverse events (SAEs). — Baseline through Week 28","Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28. — Baseline through Week 28","Mean change from baseline in central subfield thickness (CST) over time through Week 28. — Baseline through Week 28","Mean number of supplemental aflibercept IVT injections received from Week 4 through Week 28 — Week 4 through Week 28","Percentage of participants who are supplemental aflibercept injection-free through Week 28. — Baseline through Week 28"],"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.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","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/41430","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}