{"type":"trials","record":{"id":41599,"source_id":"clinicaltrials-gov","external_id":"NCT04514653","title":"RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)","brief_summary":"This interventional study is being conducted with an investigational gene therapy treatment called ABBV-RGX-314 (also known as RGX-314) and is being developed as a potential one-time gene therapy treatment for neovascular (wet) age-related macular degeneration (wet AMD or nAMD). The typical treatment for nAMD is frequent injections of anti-VEGF therapy. Researchers are testing ABBV-RGX-314 to see if it has similar effects as the current approved standard of care, such as Lucentis® or Eylea® injections. The duration of this study will be up to 52 weeks or for ranibizumab control participants who cross over to ABBV-RGX-314 after week 52, up to 80 weeks post-randomization. The primary outcome measure for this investigational study is to evaluate the mean change in best-corrected visual acuity (BCVA) for ABBV-RGX-314 compared with ranibizumab monthly at the Week 40 visit.","overall_status":"Active Not Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"AbbVie","enrollment":146,"countries":["United States"],"start_date":"2020-08-25","completion_date":"2027-02-01","last_update_date":"2026-02-27","source_url":"https://clinicaltrials.gov/study/NCT04514653","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":"AAVIATE","age_range":"50 Years to 89 Years","comparator":"Ranibizumab control","organization":"AbbVie","interventions":["Ranibizumab","ABBV-RGX-314 Dose 1","ABBV-RGX-314 Dose 2","ABBV-RGX-314 Dose 3","Local Steroid","Topical Steroid","ABBV-RGX-314 Dose 4"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean change from baseline in BCVA to Week 40 based on the Early Treatment Diabetic Retinopathy Study (ETDRS) score — 40…","Incidence of overall and ocular adverse events (AEs) and serious adverse events (SAEs) — 52 weeks","Vector shedding analysis in serum, urine, and tears — 52 Weeks","Proportion of participants who experience ocular inflammation following SCS ABBV-RGX-314 administration — 52 weeks","Mean change from baseline in choroidal neovascularization (CNV) lesion size and leakage area based on fluorescein angio…","Mean change from baseline in BCVA based on ETDRS score — Up to Week 80","Proportion of participants (1) gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 letters; (2) losing ≥ 15, ≥ 10, ≥ 5, or > 0 letters (3)…","Mean change from baseline in CRT as measured by SD-OCT — Up to Week 80","Mean supplemental anti-VEGF injection annualized rate in the ABBV-RGX-314 treatment arms — Up to Week 80","Proportion of participants who have a reduction of ≥ 50% and ≥ 75% in supplemental anti-VEGF- injection annualized rate…","Proportion of participants with 0, ≤ 1, and ≤ 2 supplemental injections — Up to Week 80","Mean percent reduction in supplemental anti-VEGF injection annualized rate — Up to Week 80","Time from ABBV-RGX-314 administration to first supplemental anti-VEGF injection — 80 Weeks","Aqueous humor ABBV-RGX- 314 TP concentration over time — 52 Weeks","Mean change from baseline in serum ABBV-RGX-314 TP concentration over time — 80 Weeks"],"design_description":"RANDOMIZED · SEQUENTIAL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Neovascular Age-Related Macular Degeneration (nAMD)","Ranibizumab","ABBV-RGX-314 Dose 1","ABBV-RGX-314 Dose 2","ABBV-RGX-314 Dose 3","Local Steroid","Topical Steroid","ABBV-RGX-314 Dose 4"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct04514653","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-08-25 to 2027-02-01","comparator":"Ranibizumab control","confidence":"structured-source","population":"ALL · 50 Years to 89 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":"2026-09-25T06:20:47.839Z","intervention":["Ranibizumab","ABBV-RGX-314 Dose 1","ABBV-RGX-314 Dose 2","ABBV-RGX-314 Dose 3","Local Steroid","Topical Steroid","ABBV-RGX-314 Dose 4"],"participants":146,"study_design":"RANDOMIZED · SEQUENTIAL · TREATMENT · SINGLE","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":["Mean change from baseline in BCVA to Week 40 based on the Early Treatment Diabetic Retinopathy Study (ETDRS) score — 40…","Incidence of overall and ocular adverse events (AEs) and serious adverse events (SAEs) — 52 weeks","Vector shedding analysis in serum, urine, and tears — 52 Weeks","Proportion of participants who experience ocular inflammation following SCS ABBV-RGX-314 administration — 52 weeks","Mean change from baseline in choroidal neovascularization (CNV) lesion size and leakage area based on fluorescein angio…","Mean change from baseline in BCVA based on ETDRS score — Up to Week 80","Proportion of participants (1) gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 letters; (2) losing ≥ 15, ≥ 10, ≥ 5, or > 0 letters (3)…","Mean change from baseline in CRT as measured by SD-OCT — Up to Week 80","Mean supplemental anti-VEGF injection annualized rate in the ABBV-RGX-314 treatment arms — Up to Week 80","Proportion of participants who have a reduction of ≥ 50% and ≥ 75% in supplemental anti-VEGF- injection annualized rate…","Proportion of participants with 0, ≤ 1, and ≤ 2 supplemental injections — Up to Week 80","Mean percent reduction in supplemental anti-VEGF injection annualized rate — Up to Week 80","Time from ABBV-RGX-314 administration to first supplemental anti-VEGF injection — 80 Weeks","Aqueous humor ABBV-RGX- 314 TP concentration over time — 52 Weeks","Mean change from baseline in serum ABBV-RGX-314 TP concentration over time — 80 Weeks"],"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/41599","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}