{"type":"trials","record":{"id":42070,"source_id":"clinicaltrials-gov","external_id":"NCT04632056","title":"A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD","brief_summary":"This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Novartis Pharmaceuticals","enrollment":329,"countries":["Japan"],"start_date":"2020-11-16","completion_date":"2022-11-10","last_update_date":"2023-11-14","source_url":"https://clinicaltrials.gov/study/NCT04632056","editorial_summary":"A registered 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":"99 Years","comparator":null,"organization":"Novartis","interventions":["Beovu"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of patients with adverse events in the eyes on therapy — 52 weeks","Number of patients with adverse events in other parts of the body (non-ocular) — 52 weeks","Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy — 52 weeks","Number of patients with SAEs and ADRs in other parts of the body (non-ocular) — 52 weeks","Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications — 52 wee…","Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only) — 52 weeks","Proportion of patients with visual acuity (VA) worsening — 52 weeks","Data on Beovu administration in the induction phase and maintenance phase — 52 weeks"],"design_description":null,"source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Beovu"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04632056","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-11-16 to 2022-11-10","comparator":null,"confidence":"structured-source","population":"ALL · 99 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":"2026-09-25T06:20:47.915Z","intervention":["Beovu"],"participants":329,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","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":["Number of patients with adverse events in the eyes on therapy — 52 weeks","Number of patients with adverse events in other parts of the body (non-ocular) — 52 weeks","Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy — 52 weeks","Number of patients with SAEs and ADRs in other parts of the body (non-ocular) — 52 weeks","Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications — 52 wee…","Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only) — 52 weeks","Proportion of patients with visual acuity (VA) worsening — 52 weeks","Data on Beovu administration in the induction phase and maintenance phase — 52 weeks"],"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":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"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/42070","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}