{"type":"trials","record":{"id":42312,"source_id":"clinicaltrials-gov","external_id":"NCT04287348","title":"Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept","brief_summary":"The purpose of this investigator initiated study is to identify the effects of intravitreal brolucizumab on recurrence-free treatment intervals and morphological features in choroidal neovascularizations (CNV) due to age-related macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6, 8 or 10 weeks intervals in a treat and extend regimen using aflibercept.","overall_status":"Terminated","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Vista Klinik","enrollment":16,"countries":["Switzerland"],"start_date":"2020-07-20","completion_date":"2021-11-22","last_update_date":"2021-12-29","source_url":"https://clinicaltrials.gov/study/NCT04287348","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Terminated. 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":"ROBIN","age_range":"50 Years","comparator":null,"organization":"Vista Klinik","interventions":["Brolucizumab 6 mg solution for intravitreal injection"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The primary outcome is the mean maximum treatment interval with intravitreal brolucizumab at month 6 and 12. — up to mo…","Best corrected visual acuity (BCVA) in letters — month 6 and 12","Number of brolucizumab intravitreal treatments applied during the 12 months study period. — 12 months","Central retinal thickness (CRT, in µm) as measured in the central ETDRS subfield Spectral-Domain Optical coherence tomo…","Presence of qualitative SD-OCT features like intraretinal fluid, subretinal fluid, pigment epithelial detachment and hy…","Total CNV area and vessel density as measured by OCTangiography (OCTA) at baseline, month 6 and 12. — month 6 and 12","Total area of leakage from CNV — baseline and month 12","VFQ-25 total evaluated by quality of life questionnaire VFQ-25 at baseline and month 6 and 12. — month 6 and 12","Rates of adverse events and serious adverse events at 6 and 12 months. — 6 and 12 months.","BCVA change (letters) from baseline (=switch to brolucizumab) — month 6 and 12","the total lesion area as evaluated by Fluorescein angiography (FA) at baseline and month 12 — baseline and month 12","VFQ-25 subscores — month 6 and 12"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Brolucizumab 6 mg solution for intravitreal injection"],"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:nct04287348","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-07-20 to 2021-11-22","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":"2026-09-25T06:20:47.950Z","intervention":["Brolucizumab 6 mg solution for intravitreal injection"],"participants":16,"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":["The primary outcome is the mean maximum treatment interval with intravitreal brolucizumab at month 6 and 12. — up to mo…","Best corrected visual acuity (BCVA) in letters — month 6 and 12","Number of brolucizumab intravitreal treatments applied during the 12 months study period. — 12 months","Central retinal thickness (CRT, in µm) as measured in the central ETDRS subfield Spectral-Domain Optical coherence tomo…","Presence of qualitative SD-OCT features like intraretinal fluid, subretinal fluid, pigment epithelial detachment and hy…","Total CNV area and vessel density as measured by OCTangiography (OCTA) at baseline, month 6 and 12. — month 6 and 12","Total area of leakage from CNV — baseline and month 12","VFQ-25 total evaluated by quality of life questionnaire VFQ-25 at baseline and month 6 and 12. — month 6 and 12","Rates of adverse events and serious adverse events at 6 and 12 months. — 6 and 12 months.","BCVA change (letters) from baseline (=switch to brolucizumab) — month 6 and 12","the total lesion area as evaluated by Fluorescein angiography (FA) at baseline and month 12 — baseline and month 12","VFQ-25 subscores — month 6 and 12"],"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/42312","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}