{"type":"trials","record":{"id":28327,"source_id":"clinicaltrials-gov","external_id":"NCT07007065","title":"Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)","brief_summary":"Neovascular age-related macular degeneration (nAMD), also known as \"wet\" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD). Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide. Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.","overall_status":"Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"AbbVie","enrollment":561,"countries":["United States","Austria","Belgium","Bulgaria","Canada","Croatia","Czechia","France","Germany","Greece","Hungary","Israel","Italy","Portugal","Puerto Rico","Spain","United Kingdom"],"start_date":"2025-11-05","completion_date":"2033-03-01","last_update_date":"2026-09-15","source_url":"https://clinicaltrials.gov/study/NCT07007065","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":null,"age_range":"50 Years","comparator":null,"organization":"AbbVie","interventions":["Surabgene Lomparvovec (ABBV-RGX-314)","Ranibizumab Control"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Annualized intravitreal anti-VEGF injection rate — Up to Week 54","Number of Participants Experiencing Adverse Events — Up to 5 years","Change from Baseline in best corrected visual acuity (BCVA) — Up to 3 Years","Annualized intravitreal anti-VEGF injection rate — Up to 3 Years"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Surabgene Lomparvovec (ABBV-RGX-314)","Ranibizumab Control"],"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:nct07007065","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-11-05 to 2033-03-01","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":"2026-09-25T06:20:47.797Z","intervention":["Surabgene Lomparvovec (ABBV-RGX-314)","Ranibizumab Control"],"participants":561,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","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":["Annualized intravitreal anti-VEGF injection rate — Up to Week 54","Number of Participants Experiencing Adverse Events — Up to 5 years","Change from Baseline in best corrected visual acuity (BCVA) — Up to 3 Years","Annualized intravitreal anti-VEGF injection rate — Up to 3 Years"],"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/28327","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}