{"type":"trials","record":{"id":42169,"source_id":"clinicaltrials-gov","external_id":"NCT04615325","title":"A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","brief_summary":"This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":37,"countries":["United States"],"start_date":"2020-12-08","completion_date":"2023-01-04","last_update_date":"2023-03-01","source_url":"https://clinicaltrials.gov/study/NCT04615325","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":"Hoffmann-La Roche","interventions":["RO7303359"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percentage of Participants With Ocular Adverse Events — Up to 12 weeks","Percentage of Participants With Systemic Adverse Events — Up to 12 weeks","Percentage of Participants With Dose-limiting Adverse Events (DLAEs), — Up to 12 weeks","Percentage of Participants With Serious Adverse Events (SAEs) — Up to 12 weeks","Percentage of Participants With Adverse Events Leading to Study Discontinuation — Up to 12 weeks","Percentage of Participants With Adverse Events of Special Interest (AESIs) — Up to 12 weeks","Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy S…"],"design_description":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Geographic Atrophy","RO7303359"],"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:nct04615325","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-12-08 to 2023-01-04","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":"2026-09-25T06:20:47.929Z","intervention":["RO7303359"],"participants":37,"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":["Percentage of Participants With Ocular Adverse Events — Up to 12 weeks","Percentage of Participants With Systemic Adverse Events — Up to 12 weeks","Percentage of Participants With Dose-limiting Adverse Events (DLAEs), — Up to 12 weeks","Percentage of Participants With Serious Adverse Events (SAEs) — Up to 12 weeks","Percentage of Participants With Adverse Events Leading to Study Discontinuation — Up to 12 weeks","Percentage of Participants With Adverse Events of Special Interest (AESIs) — Up to 12 weeks","Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy S…"],"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/42169","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}