{"type":"trials","record":{"id":42014,"source_id":"clinicaltrials-gov","external_id":"NCT03972709","title":"A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)","brief_summary":"This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.","overall_status":"Terminated","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Genentech, Inc.","enrollment":372,"countries":["United States"],"start_date":"2019-06-03","completion_date":"2022-10-27","last_update_date":"2024-03-27","source_url":"https://clinicaltrials.gov/study/NCT03972709","editorial_summary":"A registered PHASE2 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":"GALLEGO","age_range":"60 Years","comparator":null,"organization":"Genentech, Inc.","interventions":["Galegenimab","Sham Control"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) — Bas…","Percentage of Participants With Ocular Adverse Events in the Study Eye — From baseline to Week 76","Percentage of Participants With Ocular Adverse Events in the Fellow Eye — From baseline to Week 76","Percentage of Participants With Systemic Adverse Events — From baseline to Week 76","Percentage of Participants With Serious Adverse Events (SAEs) — From baseline to Week 76","Percentage of Participants With Adverse Events of Special Interest (AESIs) — From baseline to Week 76","Percentage of Participants With Adverse Events Leading to Study Discontinuation — From baseline to Week 76","Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabet…","Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart — Baseline, Week 72"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":true},"controlled_terms":["Macular Degeneration, Age-Related","Geographic Atrophy","Galegenimab","Sham Control"],"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:nct03972709","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-06-03 to 2022-10-27","comparator":null,"confidence":"structured-source","population":"ALL · 60 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":"2026-09-25T06:20:47.907Z","intervention":["Galegenimab","Sham Control"],"participants":372,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","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":["Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) — Bas…","Percentage of Participants With Ocular Adverse Events in the Study Eye — From baseline to Week 76","Percentage of Participants With Ocular Adverse Events in the Fellow Eye — From baseline to Week 76","Percentage of Participants With Systemic Adverse Events — From baseline to Week 76","Percentage of Participants With Serious Adverse Events (SAEs) — From baseline to Week 76","Percentage of Participants With Adverse Events of Special Interest (AESIs) — From baseline to Week 76","Percentage of Participants With Adverse Events Leading to Study Discontinuation — From baseline to Week 76","Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabet…","Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart — Baseline, Week 72"],"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/42014","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}