{"type":"trials","record":{"id":41857,"source_id":"clinicaltrials-gov","external_id":"NCT06006585","title":"A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy","brief_summary":"This study is open to adults with geographic atrophy, an advanced form of age-related macular degeneration. People can join the study if they are at least 50 years old. The purpose of this study is to find out how well different doses of a medicine called BI 771716 are tolerated. This study has 2 parts. Part 1 of the study takes about 3 months. In this part, participants receive 1 injection of BI 771716 directly into one of the eyes affected by geographic atrophy. Part 2 of the study takes about 4 months. In this part, participants receive 2 injections of BI 771716 directly into the eye. There are 4 weeks between the first and the second injection. In this study, BI 771716 is given to humans for the first time. The doctors compare how well participants tolerate the different doses of BI 771716. The doctors also regularly check the general health of the participants.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Boehringer Ingelheim","enrollment":20,"countries":["United States"],"start_date":"2023-10-06","completion_date":"2024-05-24","last_update_date":"2025-02-18","source_url":"https://clinicaltrials.gov/study/NCT06006585","editorial_summary":"A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Completed. 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":null,"organization":"Boehringer Ingelheim","interventions":["BI 771716"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8 — Up to 7 days","Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS) — Up to 112 days","Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS — Up to 112 days","Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax) — Up to 84 days","Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (A…","Time from dosing to maximum serum concentration of BI 771716 (tmax) — Up to 84 days","Trough concentration of BI 771716 in serum — At Day 29","BI 771716 serum concentration — At Day 57"],"design_description":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Geographic Atrophy","BI 771716"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct06006585","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-10-06 to 2024-05-24","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":"2026-09-25T06:20:47.881Z","intervention":["BI 771716"],"participants":20,"study_design":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1","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":["Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8 — Up to 7 days","Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS) — Up to 112 days","Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS — Up to 112 days","Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax) — Up to 84 days","Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (A…","Time from dosing to maximum serum concentration of BI 771716 (tmax) — Up to 84 days","Trough concentration of BI 771716 in serum — At Day 29","BI 771716 serum concentration — At Day 57"],"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/41857","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}