{"type":"trials","record":{"id":41686,"source_id":"clinicaltrials-gov","external_id":"NCT04777201","title":"A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration","brief_summary":"This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study. Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":1036,"countries":["United States","Argentina","Australia","Austria","Brazil","Bulgaria","Canada","Denmark","France","Germany","Hong Kong","Hungary","Israel","Italy","Japan","Mexico","Netherlands","Poland","Portugal","Russia","Singapore","South Korea","Spain","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom"],"start_date":"2021-04-19","completion_date":"2024-09-03","last_update_date":"2025-10-24","source_url":"https://clinicaltrials.gov/study/NCT04777201","editorial_summary":"A registered PHASE3 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":"AVONELLE-X","age_range":"50 Years","comparator":null,"organization":"Hoffmann-La Roche","interventions":["Faricimab","Sham Procedure","Anti-VEGF Therapy"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event S…","Incidence of Ocular Adverse Events in the Fellow Eye — From the date of first administration of faricimab through 28 da…","Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Gradi…","Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With…","Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With…"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration","Faricimab","Sham Procedure","Anti-VEGF Therapy"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct04777201","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-04-19 to 2024-09-03","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":"2026-09-25T06:20:47.853Z","intervention":["Faricimab","Sham Procedure","Anti-VEGF Therapy"],"participants":1036,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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":["Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event S…","Incidence of Ocular Adverse Events in the Fellow Eye — From the date of first administration of faricimab through 28 da…","Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Gradi…","Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With…","Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With…"],"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.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","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/41686","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}