{"type":"trials","record":{"id":41422,"source_id":"clinicaltrials-gov","external_id":"NCT04339764","title":"Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration","brief_summary":"Background: Age-related macular degeneration is a common eye disease in people over 50. The \"dry\" form of the disease can worsen into geographic atrophy, causing blind spots. Researchers want to learn if replacing older eye cells with younger ones can help treat this disease. Objective: To test the safety of putting cells inside the eye as a possible future treatment for dry age-related macular degeneration. Eligibility: People ages 55 and older who have geographic atrophy with loss of vision. People who have had \"wet\" macular degeneration in study eye are NOT eligible. Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Eye exam * Eye photos * Fluorescein angiography. An intravenous (IV) line is placed in an arm vein. A dye is injected. A camera takes pictures of the dye as it flows through the eyes' blood vessels. * Electroretinography. An electrode is taped to participants' forehead. They sit in the dark. After 30 minutes, numbing eye drops and contact lenses are placed in their eyes. They watch flashing lights. * Tuberculosis test * Chest X-ray * Electrocardiography. Sticky pads are placed on participants' chest to record the heart's electrical activity. Participants will have at least 14 study visits over 5 and a half years. They will repeat screening tests. Participants will have retinal pigment epithelium (RPE) transplantation surgery in one eye. For this, cells from participants' blood are turned into RPE cells. These cells are placed in their eye through a cut in their retina. They will get dilating eye drops, an IV line, and anesthesia that may make them sleep. A gas bubble will be put in their eye to help it heal. Participants will receive immunosuppressive medications to avoid transplant rejection. Participants will be contacted yearly for up to 15 years.","overall_status":"Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"National Eye Institute (NEI)","enrollment":20,"countries":["United States"],"start_date":"2020-09-23","completion_date":"2029-05-31","last_update_date":"2026-08-10","source_url":"https://clinicaltrials.gov/study/NCT04339764","editorial_summary":"A registered PHASE1, 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":"55 Years to 95 Years","comparator":null,"organization":"National Institutes of Health Clinical Center (CC)","interventions":["iPSC-derived RPE/PLGA transplantation"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Summary of adverse events — 12 months compared to final Baseline prior to surgery","Visual acuity change — 12 months compared to final Baseline prior to surgery","Retinal structure (fluorescein angiography) — 12, 24, and 60 month","Retinal Structure (color and autofluorescence imaging) — 12, 24, and 60 months","Multifocal electroretinography responses — 12, 24, and 60 months","Retinal sensitivity and fixation (microperimetry) — 12, 24, and 60 months","Retinal Structure (optical coherence tomography) — 12, 24, and 60 months","Visual acuity change — 24 and 60 months","Summary of adverse events — 24 and 60 months"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Dry Age-Related Macular Degeneration","Geographic Atrophy","iPSC-derived RPE/PLGA transplantation"],"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:nct04339764","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-09-23 to 2029-05-31","comparator":null,"confidence":"structured-source","population":"ALL · 55 Years to 95 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":"2026-09-25T06:20:47.809Z","intervention":["iPSC-derived RPE/PLGA transplantation"],"participants":20,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, 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":["Summary of adverse events — 12 months compared to final Baseline prior to surgery","Visual acuity change — 12 months compared to final Baseline prior to surgery","Retinal structure (fluorescein angiography) — 12, 24, and 60 month","Retinal Structure (color and autofluorescence imaging) — 12, 24, and 60 months","Multifocal electroretinography responses — 12, 24, and 60 months","Retinal sensitivity and fixation (microperimetry) — 12, 24, and 60 months","Retinal Structure (optical coherence tomography) — 12, 24, and 60 months","Visual acuity change — 24 and 60 months","Summary of adverse events — 24 and 60 months"],"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/41422","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}