{"type":"trials","record":{"id":41873,"source_id":"clinicaltrials-gov","external_id":"NCT04985487","title":"Regulatory Post-Marketing Surveillance Study for Brolucizumab","brief_summary":"This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.","overall_status":"Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Novartis Pharmaceuticals","enrollment":3000,"countries":["South Korea"],"start_date":"2021-08-18","completion_date":"2026-06-14","last_update_date":"2025-01-14","source_url":"https://clinicaltrials.gov/study/NCT04985487","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. 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 to 100 Years","comparator":null,"organization":"Novartis","interventions":["brolucizumab"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence of adverse events at 12 weeks — 12 weeks","Incidence of adverse events at 24 weeks and optionally at 36 weeks — Up to 36 weeks","Proportion of patients gaining or losing more than 15 letters on the ETDRS chart — Week 12, week 24, optionally week 36","Mean change of Central Subfield Thickness (CST) from baseline — Baseline, week 12, week 24, optionally week 36","Mean change of Best Corrected Visual Acuity (BCVA) from baseline — Baseline, week 12, week 24, optionally week 36","Mean Best Corrected Visual Acuity (BCVA) — Baseline, week 12, week 24, optionally week 36","Mean Central Subfield Thickness (CST) — Baseline, Week 12, week 24, optionally week 36","Number of injections — Up to 36 weeks","Percentage of patients completing the loading phase — 4 months","Percentage of patients who maintained with 12 weeks interval — Up to 36 weeks","Proportion of patients with retinal fluid — Week 12, week 24, optionally week 36","Prior anti-VEGF treatment history - number of prior injections — Baseline","Prior anti-VEGF treatment history - agent of prior injections — Baseline","Predictive factors of treatment outcomes (persistent disease activity) — Week 24","Treatment naïve/non-naïve — Baseline","Treatment interval — Up to week 36","Concomitant treatments — Baseline","Number of participants with post injection empirical treatment — Week 12, week 24, optionally week 36"],"design_description":null,"source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","brolucizumab"],"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:nct04985487","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-08-18 to 2026-06-14","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years to 100 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":"2026-09-25T06:20:47.884Z","intervention":["brolucizumab"],"participants":3000,"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":["Incidence of adverse events at 12 weeks — 12 weeks","Incidence of adverse events at 24 weeks and optionally at 36 weeks — Up to 36 weeks","Proportion of patients gaining or losing more than 15 letters on the ETDRS chart — Week 12, week 24, optionally week 36","Mean change of Central Subfield Thickness (CST) from baseline — Baseline, week 12, week 24, optionally week 36","Mean change of Best Corrected Visual Acuity (BCVA) from baseline — Baseline, week 12, week 24, optionally week 36","Mean Best Corrected Visual Acuity (BCVA) — Baseline, week 12, week 24, optionally week 36","Mean Central Subfield Thickness (CST) — Baseline, Week 12, week 24, optionally week 36","Number of injections — Up to 36 weeks","Percentage of patients completing the loading phase — 4 months","Percentage of patients who maintained with 12 weeks interval — Up to 36 weeks","Proportion of patients with retinal fluid — Week 12, week 24, optionally week 36","Prior anti-VEGF treatment history - number of prior injections — Baseline","Prior anti-VEGF treatment history - agent of prior injections — Baseline","Predictive factors of treatment outcomes (persistent disease activity) — Week 24","Treatment naïve/non-naïve — Baseline","Treatment interval — Up to week 36","Concomitant treatments — Baseline","Number of participants with post injection empirical treatment — Week 12, week 24, optionally week 36"],"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/41873","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}