{"type":"trials","record":{"id":28293,"source_id":"clinicaltrials-gov","external_id":"NCT07029945","title":"A Phase 1/2 Study of the Safety and Efficacy of BRX011 Oral Administration Once Daily in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration","brief_summary":"This study aims to evaluate the safety and efficacy of BRX011, an oral medication, taken once daily by participants with geographic atrophy secondary to age-related macular degeneration. The study is conducted in phases 1 and 2, focusing on assessing both safety (tolerability) and effectiveness (efficacy) of the treatment. Participants: Adults with geographic atrophy due to age-related macular degeneration. Treatment: BRX011 or Placebo is taken once daily as per the protocol. Duration: The study involves multiple visits over 96 weeks to monitor participants' health and response to treatment. Safety Monitoring: Regular checks for adverse events and health status to ensure participant well-being. Checks will include examination of vital signs, clinical labs, ocular exams, and ocular imaging. Primary Outcome Measure: Efficacy of BRX011 in the annual rate of change in the square root of GA area, as specified in the protocol.","overall_status":"Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Biojiva LLC","enrollment":152,"countries":["United States","Australia"],"start_date":"2026-09-29","completion_date":"2029-04-01","last_update_date":"2026-09-23","source_url":"https://clinicaltrials.gov/study/NCT07029945","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":"2026-09-25T00:17:13.08831+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"BELLAVISTA","age_range":"55 Years","comparator":"BRX011; Safflower Oil","organization":"Biojiva LLC","interventions":["BRX011","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Annual rate of change in the square root of GA area — Baseline (Day 0) to Week 96","Change in low luminance deficit — Baseline (Day 0) to Week 96","Change in ETDRS BCVA — Baseline (Day 0) to Week 96"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Geographic Atrophy","BRX011","Placebo"],"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:nct07029945","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-09-29 to 2029-04-01","comparator":"BRX011; Safflower Oil","confidence":"structured-source","population":"ALL · 55 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":"2026-09-25T06:20:47.790Z","intervention":["BRX011","Placebo"],"participants":152,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","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":["Annual rate of change in the square root of GA area — Baseline (Day 0) to Week 96","Change in low luminance deficit — Baseline (Day 0) to Week 96","Change in ETDRS BCVA — Baseline (Day 0) to Week 96"],"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.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","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/28293","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}