{"type":"trials","record":{"id":41441,"source_id":"clinicaltrials-gov","external_id":"NCT04543331","title":"Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema","brief_summary":"This study is a prospective, non-interventional, multicenter, open-label study in nAMD and DME patients being treated with brolucizumab according to the EU SmPC. An observational study design, without a strict, mandated visit schedule or mandated treatment regimen was chosen as the most appropriate to collect available data in a real life setting. For that reason, this NIS does not impose a therapy protocol, diagnostic/therapeutic procedure or a visit schedule. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care and will take place as per investigator's discretion. This includes e.g. visit frequency, injection frequency and types of assessments performed - only data from routine medical practice will be collected as part of the study.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Novartis Pharmaceuticals","enrollment":572,"countries":["Germany"],"start_date":"2020-11-05","completion_date":"2025-11-17","last_update_date":"2026-07-29","source_url":"https://clinicaltrials.gov/study/NCT04543331","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":"BLUE SKY","age_range":"18 Years to 99 Years","comparator":null,"organization":"Novartis","interventions":["brolucizumab"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percentage of patients' eyes that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) — Month 12","Mean change in visual actuity (VA) under clinic specific routine treatment schemes — Baseline, month 12","Morphological CNV-Changes under clinic specific routine treatment schemes — Baseline, month 12","Percent of patients maintained on q12w dosing after loading through Week 52 — After loading, month 12","Change in interval length from last interval before switch (baseline) to last interval at end of follow-up (12 months)…","Characterize nAMD patients who initiated treatment with brolucizumab with the respect to baseline characteristics — Bas…","Evaluate anatomical parameters during treatment with brolucizumab — Up to month 24","Evaluate VA change from baseline during treatment with brolucizumab — Baseline, month 24","Estimate number of anti-VEGF injections, visits and injection intervals — Up to month 24","Estimate percentage of switchers during first 6 months and characterize switchers — Baseline, month 6","Estimate discontinuation rate and time to discontinuation — Month 1-12 and 13-24","Assess retreatment criteria — Up to month 24","Estimate the number of OCT — Month 1-12 and 13-24","Assess the safety of brolucizumab — Up to month 24","Evaluate anatomical effectiveness — Up to month 24","Evaluate treatment intervals — Up to month 24","Describe implementation of treatment schemes into clinical practice — Up to month 24","Evaluate morphological changes under brolucizumab treatment using multimodal imaging — Up to month 24","Percentage of patient's eyes with absence of IRF and/or SRF at month 12 (naive and switch) — Month 12","Evaluate anatomical parameters during treatment with brolucizumab — Month 1-12 and 13-24"],"design_description":null,"source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration (nAMD)","Diabetic Macular Edema (DME)","brolucizumab"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"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:nct04543331","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-11-05 to 2025-11-17","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years to 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":"2026-09-25T06:20:47.813Z","intervention":["brolucizumab"],"participants":572,"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":["Percentage of patients' eyes that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) — Month 12","Mean change in visual actuity (VA) under clinic specific routine treatment schemes — Baseline, month 12","Morphological CNV-Changes under clinic specific routine treatment schemes — Baseline, month 12","Percent of patients maintained on q12w dosing after loading through Week 52 — After loading, month 12","Change in interval length from last interval before switch (baseline) to last interval at end of follow-up (12 months)…","Characterize nAMD patients who initiated treatment with brolucizumab with the respect to baseline characteristics — Bas…","Evaluate anatomical parameters during treatment with brolucizumab — Up to month 24","Evaluate VA change from baseline during treatment with brolucizumab — Baseline, month 24","Estimate number of anti-VEGF injections, visits and injection intervals — Up to month 24","Estimate percentage of switchers during first 6 months and characterize switchers — Baseline, month 6","Estimate discontinuation rate and time to discontinuation — Month 1-12 and 13-24","Assess retreatment criteria — Up to month 24","Estimate the number of OCT — Month 1-12 and 13-24","Assess the safety of brolucizumab — Up to month 24","Evaluate anatomical effectiveness — Up to month 24","Evaluate treatment intervals — Up to month 24","Describe implementation of treatment schemes into clinical practice — Up to month 24","Evaluate morphological changes under brolucizumab treatment using multimodal imaging — Up to month 24","Percentage of patient's eyes with absence of IRF and/or SRF at month 12 (naive and switch) — Month 12","Evaluate anatomical parameters during treatment with brolucizumab — Month 1-12 and 13-24"],"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.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","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/41441","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}