{"type":"trials","record":{"id":41555,"source_id":"clinicaltrials-gov","external_id":"NCT04704921","title":"Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD","brief_summary":"ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.","overall_status":"Active Not Recruiting","phases":["PHASE2","PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"AbbVie","enrollment":671,"countries":["United States"],"start_date":"2020-12-29","completion_date":"2027-11-01","last_update_date":"2026-04-28","source_url":"https://clinicaltrials.gov/study/NCT04704921","editorial_summary":"A registered PHASE2, 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":"ATMOSPHERE","age_range":"50 Years to 89 Years","comparator":"Control Arm","organization":"AbbVie","interventions":["ABBV-RGX-314","Ranibizumab (LUCENTIS®)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean change from baseline in Best Corrected Visual Acuity (BCVA) — At Week 54","Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs — Week 50","Incidences of ocular and overall AEs over 54 weeks — Through Week 54","Incidences of ocular and overall AEs over 98 weeks — Through Week 98","Mean change from baseline in BCVA to Week 98 (ABBV-RGX-314 randomized participants) based on the ETDRS score — Week 98","Proportion of participants with worsened BCVA — Week 54; Week 98","Proportion of participants with improved BCVA — Week 54; Week 98","Proportion of participants (1) gaining > 0 letters; (2) losing > 0 letters; maintaining vision (not losing ≥ 15 letters…","Mean change from baseline in BCVA for participants who received 0 or more supplemental anti-VEGF injections (ABBV-RGX-3…","Mean change from Week 54 to Week 98 in BCVA (control arm participants who cross over to ABBV-RGX-314) — Week 54 to Week…","Mean change from baseline in CRT as measured by SD-OCT — Week 54; (ABBV-RGX-314 randomized participants) Week 98","Mean change from Week 54 to Week 98 in CRT as measured by SD-OCT (control arm participants who cross over to ABBV-RGX-3…","Mean change from baseline in CPT as measured by SD-OCT — Week 54; (ABBV-RGX-314 randomized participants) Week 98","Mean change from Week 54 to Week 98 in CPT as measured by SD-OCT (control arm participants who cross over to ABBV-RGX-3…","Mean number of supplemental anti-VEGF injections from Baseline through Week 54 (ABBV-RGX-314 randomized participants) a…","Proportion of participants with 0, 1, 2, and 3 supplemental injections through Week 54 and Week 98 (ABBV-RGX-314 random…","Proportion of participants with ≤ 1, ≤ 2, and ≤ 3 supplemental injections through Week 54 and Week 98 (ABBV-RGX-314 ran…","Proportion of participants that received 1 or 2 injections through Week 54 and Week 98 (ABBV-RGX-314 randomized partici…","Proportion of participants with a reduction of ≥ 50% in anti-VEGF injection annualized rate through Week 54 and Week 98…","Proportion of participants with a reduction of ≥ 75% in anti-VEGF injection annualized rate through Week 54 and Week 98…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["AMD","nAMD","Wet Age-related Macular Degeneration","wAMD","Wet AMD","CNV","Neovascular AMD","Neovascular Age-related Macular Degeneration","Choroidal Neovascularization","ABBV-RGX-314","Ranibizumab (LUCENTIS®)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04704921","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-12-29 to 2027-11-01","comparator":"Control Arm","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":"2026-09-25T06:20:47.833Z","intervention":["ABBV-RGX-314","Ranibizumab (LUCENTIS®)"],"participants":671,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2, 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) — At Week 54","Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs — Week 50","Incidences of ocular and overall AEs over 54 weeks — Through Week 54","Incidences of ocular and overall AEs over 98 weeks — Through Week 98","Mean change from baseline in BCVA to Week 98 (ABBV-RGX-314 randomized participants) based on the ETDRS score — Week 98","Proportion of participants with worsened BCVA — Week 54; Week 98","Proportion of participants with improved BCVA — Week 54; Week 98","Proportion of participants (1) gaining > 0 letters; (2) losing > 0 letters; maintaining vision (not losing ≥ 15 letters…","Mean change from baseline in BCVA for participants who received 0 or more supplemental anti-VEGF injections (ABBV-RGX-3…","Mean change from Week 54 to Week 98 in BCVA (control arm participants who cross over to ABBV-RGX-314) — Week 54 to Week…","Mean change from baseline in CRT as measured by SD-OCT — Week 54; (ABBV-RGX-314 randomized participants) Week 98","Mean change from Week 54 to Week 98 in CRT as measured by SD-OCT (control arm participants who cross over to ABBV-RGX-3…","Mean change from baseline in CPT as measured by SD-OCT — Week 54; (ABBV-RGX-314 randomized participants) Week 98","Mean change from Week 54 to Week 98 in CPT as measured by SD-OCT (control arm participants who cross over to ABBV-RGX-3…","Mean number of supplemental anti-VEGF injections from Baseline through Week 54 (ABBV-RGX-314 randomized participants) a…","Proportion of participants with 0, 1, 2, and 3 supplemental injections through Week 54 and Week 98 (ABBV-RGX-314 random…","Proportion of participants with ≤ 1, ≤ 2, and ≤ 3 supplemental injections through Week 54 and Week 98 (ABBV-RGX-314 ran…","Proportion of participants that received 1 or 2 injections through Week 54 and Week 98 (ABBV-RGX-314 randomized partici…","Proportion of participants with a reduction of ≥ 50% in anti-VEGF injection annualized rate through Week 54 and Week 98…","Proportion of participants with a reduction of ≥ 75% in anti-VEGF injection annualized rate through Week 54 and Week 98…"],"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":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/41555","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}