{"type":"trials","record":{"id":42094,"source_id":"clinicaltrials-gov","external_id":"NCT04002310","title":"A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy","brief_summary":"This is a study in adults with geographic atrophy, an advanced form of age-related macular degeneration. The purpose of this study is to find out how well different doses of BI 754132 are tolerated. The participants are in the study for about 4 months. During this time, they visit the study site about 10 times. Participants receive 1 injection of BI 754132 directly into one of the eyes affected by geographic atrophy. In this study, BI 754132 is given to humans for the first time. The doctors compare how well participants tolerate the different doses of BI 754132. The doctors also regularly check the general health of the participants.","overall_status":"Terminated","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Boehringer Ingelheim","enrollment":18,"countries":["United States","United Kingdom"],"start_date":"2019-07-26","completion_date":"2022-08-09","last_update_date":"2023-09-15","source_url":"https://clinicaltrials.gov/study/NCT04002310","editorial_summary":"A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Terminated. 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 754132"],"registry_source":"ClinicalTrials.gov","outcome_measures":["SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs) — From drug adminis…","MD Part: Number of Patients With Drug Related Adverse Events (AEs) — From drug administration until end of trial, up to…","SRD Part: Number of Patients With Drug-related Adverse Events (AEs) — From drug administration until end of trial, up t…","SRD Part: Number of Patients With Any Ocular Adverse Events (AEs) in the Study Eye — From drug administration until end…","SRD Part: Maximum Serum Concentration of BI 754132 After a Single Intravitreal Dose (Cmax) — At Day 1, 4, 8, 15, 29, 56…","SRD Part: Area Under the Concentration-time Curve of BI 754132 in Serum Over the Time Interval From 0 Extrapolated to I…","SRD Part: Time From Dosing to Maximum Serum Concentration of BI 754132 (Tmax) — At Day 1, 4, 8, 15, 29, 56, 84 and Day…","MD Part: Trough Levels of BI 754132 Before Second Administration (Cmin,1) — Up to 29 days.","MD Part: Trough Levels of BI 754132 Before Third Administration (Cmin,2) — Up to 57 days.","MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration — At Day 85, 113 and Day 15…"],"design_description":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Macular Degeneration","BI 754132"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"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:nct04002310","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-07-26 to 2022-08-09","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":"2026-09-25T06:20:47.919Z","intervention":["BI 754132"],"participants":18,"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":["SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs) — From drug adminis…","MD Part: Number of Patients With Drug Related Adverse Events (AEs) — From drug administration until end of trial, up to…","SRD Part: Number of Patients With Drug-related Adverse Events (AEs) — From drug administration until end of trial, up t…","SRD Part: Number of Patients With Any Ocular Adverse Events (AEs) in the Study Eye — From drug administration until end…","SRD Part: Maximum Serum Concentration of BI 754132 After a Single Intravitreal Dose (Cmax) — At Day 1, 4, 8, 15, 29, 56…","SRD Part: Area Under the Concentration-time Curve of BI 754132 in Serum Over the Time Interval From 0 Extrapolated to I…","SRD Part: Time From Dosing to Maximum Serum Concentration of BI 754132 (Tmax) — At Day 1, 4, 8, 15, 29, 56, 84 and Day…","MD Part: Trough Levels of BI 754132 Before Second Administration (Cmin,1) — Up to 29 days.","MD Part: Trough Levels of BI 754132 Before Third Administration (Cmin,2) — Up to 57 days.","MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration — At Day 85, 113 and Day 15…"],"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/42094","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}