{"type":"trials","record":{"id":41826,"source_id":"clinicaltrials-gov","external_id":"NCT05269966","title":"Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)","brief_summary":"The purpose of this study was to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) patients that more closely resemble the real-world population intended to be treated with brolucizumab. This study was conducted as part of the post-marketing regulatory commitment to the Indian Health authority.","overall_status":"Completed","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Novartis Pharmaceuticals","enrollment":105,"countries":["India"],"start_date":"2022-03-09","completion_date":"2023-08-29","last_update_date":"2025-03-20","source_url":"https://clinicaltrials.gov/study/NCT05269966","editorial_summary":"A registered PHASE4 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 to 100 Years","comparator":null,"organization":"Novartis","interventions":["Injection Brolucizumab"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.…","Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Prefer…","Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab — Adverse event…","Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Trea…","Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment…","Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabe…","Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or…","Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or…","Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye — Week 56","Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab — Week 56","Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab. — Week 56","Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 W…","Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks. — Week…","Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 5…","Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56…","Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye — Baseline, Week 16 and Week 56","Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye — Baseline, Week 16 and Week 56"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration (nAMD)","Injection Brolucizumab"],"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:nct05269966","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-03-09 to 2023-08-29","comparator":null,"confidence":"structured-source","population":"ALL · 50 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":"2026-09-25T06:20:47.877Z","intervention":["Injection Brolucizumab"],"participants":105,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","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 and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.…","Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Prefer…","Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab — Adverse event…","Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Trea…","Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment…","Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabe…","Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or…","Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or…","Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye — Week 56","Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab — Week 56","Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab. — Week 56","Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 W…","Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks. — Week…","Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 5…","Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56…","Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye — Baseline, Week 16 and Week 56","Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye — Baseline, Week 16 and Week 56"],"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/41826","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}