{"type":"trials","record":{"id":42142,"source_id":"clinicaltrials-gov","external_id":"NCT05834075","title":"A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India","brief_summary":"This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Anonymized data of patients treated with brolucizumab intravitreal injection (IVI) who had received the first dose of brolucizumab between 01 October 2020 and 31 March 2021 was collected. Patients could either be treatment-naïve or previously treated with single or a combination of other IVI of anti-vascular endothelial growth factors (VEGFs). The primary outcome measure was the change in fluid levels (intra-retinal fluid \\[IRF\\], sub-retinal fluid \\[SRF\\], and pigment epithelial detachment \\[PED\\]) from baseline to Month 3. Secondary outcome measures included change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), number of brolucizumab injections, and safety (number of adverse events \\[AEs\\]). Descriptive statistics were tabulated for the demographic and clinical characteristics as well as outcome variables.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Novartis Pharmaceuticals","enrollment":63,"countries":["India"],"start_date":"2022-01-05","completion_date":"2022-04-22","last_update_date":"2023-04-28","source_url":"https://clinicaltrials.gov/study/NCT05834075","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":"50 Years","comparator":null,"organization":"Novartis","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline — From baseline to Month 3","Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline — From baseline to Month 3","Percentage of patients with absence or reduction of PED at Month 3 compared to baseline — From baseline to Month 3","Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR) — Bas…","Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline — Baseline, Months 1 and…","Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline — Baseline, Months 1 and…","Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline — Baseline, Months 1 and…","Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT) — Baseline, Mo…","Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment — Months 1, 2, and 3","Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment — Months 1, 2, and 3","Number of visits during Months 1, 2, and 3 of brolucizumab treatment — Months 1, 2, and 3","Number of patients with treatment-emergent adverse events — Baseline to Month 3"],"design_description":null,"source_has_results":false},"controlled_terms":["Neurovascular Age-related Macular Degeneration"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"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:nct05834075","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-01-05 to 2022-04-22","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":"2026-09-25T06:20:47.926Z","intervention":[],"participants":63,"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 with absence or reduction of IRF at Month 3 compared to baseline — From baseline to Month 3","Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline — From baseline to Month 3","Percentage of patients with absence or reduction of PED at Month 3 compared to baseline — From baseline to Month 3","Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR) — Bas…","Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline — Baseline, Months 1 and…","Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline — Baseline, Months 1 and…","Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline — Baseline, Months 1 and…","Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT) — Baseline, Mo…","Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment — Months 1, 2, and 3","Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment — Months 1, 2, and 3","Number of visits during Months 1, 2, and 3 of brolucizumab treatment — Months 1, 2, and 3","Number of patients with treatment-emergent adverse events — Baseline to Month 3"],"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 OBSERVATIONAL."],"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/42142","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}