{"type":"trials","record":{"id":41443,"source_id":"clinicaltrials-gov","external_id":"NCT06769048","title":"A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy","brief_summary":"This study is open to adults aged 50 years and older with geographic atrophy that was diagnosed by imaging of the retina. The purpose of this study is to find out whether a medicine called BI 1584862 improves the eyes in people with geographic atrophy and to find the most suitable dose. This study has 4 treatment groups. Participants are put into groups randomly, which means by chance. Initially participants can join a BI 1584862 and a placebo group; then more participants are put randomly in 2 additional BI 1584862 groups and a placebo group. Participants are in the study for 1 year. During this time, they visit the study site 13 times. At the visits, doctors check the severity of participants' eye disease and collect information on any health problems. They take detailed pictures of the back of the eye, the retina, with imaging methods called fundus autofluorescence (FAF), near-infrared reflectance (NIR), and optical coherence tomography (OCT). They measure areas of the retina that appear healthy (bright) or start to waste away (dark, atrophy). The changes over time are then compared between the treatment groups.","overall_status":"Active Not Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Boehringer Ingelheim","enrollment":150,"countries":["United States","Puerto Rico"],"start_date":"2025-01-31","completion_date":"2027-01-05","last_update_date":"2026-07-28","source_url":"https://clinicaltrials.gov/study/NCT06769048","editorial_summary":"A registered PHASE2 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":null,"age_range":"50 Years","comparator":"Placebo-matching BI 1584862","organization":"Boehringer Ingelheim","interventions":["Placebo-matching BI 1584862","BI 1584862"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluores…","Key secondary endpoint: Change from baseline in total attenuation as a percentage of the EZ at the macular area with a…","Key secondary endpoint: Slope of change from baseline in square root transformed GA area as measured by OCT over a tria…","Occurrence of TEAES from drug administration until Week 52 — Up to week 52.","Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickne…","Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FA…","Occurrence of BCVA letter loss of ≥15 from baseline in the study eye as measured by standardized ETDRS chart for at lea…","Change from baseline in best-corrected low luminance visual deficit (LLVD) score as measured in letters by ETDRS chart…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Geographic Atrophy","Placebo-matching BI 1584862","BI 1584862"],"relevance_confidence":80,"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:nct06769048","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-01-31 to 2027-01-05","comparator":"Placebo-matching BI 1584862","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":"2026-09-25T06:20:47.813Z","intervention":["Placebo-matching BI 1584862","BI 1584862"],"participants":150,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","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":["Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluores…","Key secondary endpoint: Change from baseline in total attenuation as a percentage of the EZ at the macular area with a…","Key secondary endpoint: Slope of change from baseline in square root transformed GA area as measured by OCT over a tria…","Occurrence of TEAES from drug administration until Week 52 — Up to week 52.","Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickne…","Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FA…","Occurrence of BCVA letter loss of ≥15 from baseline in the study eye as measured by standardized ETDRS chart for at lea…","Change from baseline in best-corrected low luminance visual deficit (LLVD) score as measured in letters by ETDRS chart…"],"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.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"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/41443","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}