{"type":"trials","record":{"id":42089,"source_id":"clinicaltrials-gov","external_id":"NCT05569148","title":"A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe","brief_summary":"This Phase IIIb, single-arm, open-label multicenter clinical in-use study in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is designed to assess the ability of the intended users, healthcare providers (HCPs), to follow the Instructions for Use to perform an intravitreal (IVT) injection using the 6-milligram (mg) faricimab prefilled syringe (PFS) configuration per the intended use. Any adverse events occurring during the 7-day study reporting period will be summarized.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":35,"countries":["United States"],"start_date":"2022-10-17","completion_date":"2022-11-10","last_update_date":"2023-10-10","source_url":"https://clinicaltrials.gov/study/NCT05569148","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":null,"age_range":"18 Years","comparator":null,"organization":"Hoffmann-La Roche","interventions":["Faricimab PFS Configuration"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in t…","Percentage of Injection Procedures With Use Errors on Critical Tasks Performed by Healthcare Providers in the Use of th…"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration","Diabetic Macular Edema","Faricimab PFS Configuration"],"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:nct05569148","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-10-17 to 2022-11-10","comparator":null,"confidence":"structured-source","population":"ALL · 18 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":"2026-09-25T06:20:47.918Z","intervention":["Faricimab PFS Configuration"],"participants":35,"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":["Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in t…","Percentage of Injection Procedures With Use Errors on Critical Tasks Performed by Healthcare Providers in the Use of th…"],"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/42089","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}