{"type":"trials","record":{"id":41977,"source_id":"clinicaltrials-gov","external_id":"NCT03999801","title":"Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy","brief_summary":"This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study in which they received a single subretinal administration of RGX-314 in their study eye. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. Participants will be followed for up to 5 years post-RGX-314 administration (inclusive of the parent study). After enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-RGX-314 administration follow-up period. Additionally, an interventional fellow eye treatment substudy will evaluate the safety, efficacy, and immunogenicity of subretinal RGX-314 administration in the fellow eye of participants having bilateral disease who previously received a subretinal injection of RGX-314 in their study eye. Participants who qualify for the substudy will receive subretinal administration of RGX-314 in their fellow eye and complete 13 study visits in a 54-week period. Following completion of the substudy participants will continue in the observational portion of the study for up to 5 years post RGX-314 administration in their fellow eye.","overall_status":"Enrolling By Invitation","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"AbbVie","enrollment":865,"countries":["United States"],"start_date":"2019-05-31","completion_date":"2028-12-01","last_update_date":"2024-06-17","source_url":"https://clinicaltrials.gov/study/NCT03999801","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Enrolling By Invitation. 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":"RGX-314 SRLTFU","age_range":"50 Years","comparator":"Main Observational Study","organization":"AbbVie","interventions":["RGX-314"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence of ocular adverse events and any serious adverse events in the study eye — 5 years inclusive of parent study","Fellow eye substudy: Incidence of ocular adverse events and any serious adverse events in the fellow eye — 54 weeks","Change from baseline in best corrected visual acuity (BCVA) in the study eye — 5 years inclusive of parent study","Change from baseline in Central Retinal Thickness (CRT) in the study eye — 5 years inclusive of parent study","Number of supplemental anti-VEGF injections in the study eye — 5 years inclusive of parent study","Number of retinal specialist visits for the study eye — 5 years inclusive of parent study","Fellow eye substudy: Change from baseline in best corrected visual acuity — 54 weeks","Fellow eye substudy: Change from baseline in Central Retinal Thickness in the fellow eye — 54 weeks","Fellow eye substudy: Number of supplemental anti-VEGF injections in the fellow eye — 54 weeks","Fellow eye substudy: Aqueous and Serum RGX-314 transgene product (TP) concentrations in the fellow eye — 54 weeks","Fellow eye substudy: Immunogenicity measurements in the fellow eye — 54 weeks"],"design_description":"NON RANDOMIZED · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Wet Macular Degeneration","RGX-314"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct03999801","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-05-31 to 2028-12-01","comparator":"Main Observational Study","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":"2026-09-25T06:20:47.902Z","intervention":["RGX-314"],"participants":865,"study_design":"NON RANDOMIZED · 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 and any serious adverse events in the study eye — 5 years inclusive of parent study","Fellow eye substudy: Incidence of ocular adverse events and any serious adverse events in the fellow eye — 54 weeks","Change from baseline in best corrected visual acuity (BCVA) in the study eye — 5 years inclusive of parent study","Change from baseline in Central Retinal Thickness (CRT) in the study eye — 5 years inclusive of parent study","Number of supplemental anti-VEGF injections in the study eye — 5 years inclusive of parent study","Number of retinal specialist visits for the study eye — 5 years inclusive of parent study","Fellow eye substudy: Change from baseline in best corrected visual acuity — 54 weeks","Fellow eye substudy: Change from baseline in Central Retinal Thickness in the fellow eye — 54 weeks","Fellow eye substudy: Number of supplemental anti-VEGF injections in the fellow eye — 54 weeks","Fellow eye substudy: Aqueous and Serum RGX-314 transgene product (TP) concentrations in the fellow eye — 54 weeks","Fellow eye substudy: Immunogenicity measurements in the fellow eye — 54 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":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"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/41977","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}