{"type":"trials","record":{"id":42283,"source_id":"clinicaltrials-gov","external_id":"NCT04988178","title":"Analysis of naïve Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.","brief_summary":"Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50 years old. Neovascular AMD, the most severe form and the most severe is characterized by the appearance, spread and growth of subretinal neovessels. One of the major molecular mediators is the endothelial growth factor vascular (VEGF). Intra-vitreous (IVI) injection of an anti-VEGF may slow the progression of Neovascular AMD and stabilize vision in the majority of cases. Ranibizumab (Lucentis®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD. At the start of its use, ranibizumab was first injected monthly and then according to the \"reactive\" protocol. Over time, a new strategy of treatment was born: the \"treat-and-extend\" (T\\&E). This is 'made to measure' protocol for each patient aiming to reduce the frequency of injections while guaranteeing inactivity of the disease. It starts with the loading dose, i.e. 3 injections given 4 weeks apart. Subsequently, the interval is lengthened by slices of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IIV. The efficacy and safety of ranibizumab, when used in a proactive regimen of T\\&E, has been shown in the CANTREAT randomized controlled trial. However, there is a lack of more data on T\\&E used in current practice, and particularly on the number of injections and treatment intervals over a minimum treatment period of 24 months. The aim of this retrospective study carried out at the CHU Brugmann Hospital is to determine the number of injections and the intervals necessary to have encouraging results in visual acuity over a treatment period of at least two years.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Brugmann University Hospital","enrollment":34,"countries":["Belgium"],"start_date":"2021-04-13","completion_date":"2021-09-22","last_update_date":"2022-03-21","source_url":"https://clinicaltrials.gov/study/NCT04988178","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":"Brugmann University Hospital","interventions":["Data extraction from medical files"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Injections number (first 24 months of treatment) — first 24 months of treatment","Injections interval — during the 2nd year of treatment","Injection number (up to 4 years of treatment) — up to 4 years of treatment","Injections interval (up to 4 years of treatment) — up to 4 years of treatment","Most stable injection interval — up to 4 years of treatment","Overall extension interval — up to 4 years of treatment","Covid 19 impact — up to 4 years of treatment","Number of follow-up visits — up to 4 years of treatment","Visual acuity — up to 4 years of treatment","Age — Baseline","Eye lesion type — Baseline","Fluid — Baseline","Fluid — 90 days after baseline","Fluid — once a year up to 4 years of treatment","Date of first symptoms — Baseline","Date of first injection — Baseline","Retinal thickness — up to 4 years of treatment","Treatment regimen — first 12 months of treatment]","Number of patients stopping treatment (12-24 months) — between 12 and 24 months of treatment","Reason for stopping treatment (12-24 months) — between 12 and 24 months of treatment"],"design_description":null,"source_has_results":false},"controlled_terms":["Macular Degeneration","Data extraction from medical files"],"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:nct04988178","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-04-13 to 2021-09-22","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":"2026-09-25T06:20:47.946Z","intervention":["Data extraction from medical files"],"participants":34,"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":["Injections number (first 24 months of treatment) — first 24 months of treatment","Injections interval — during the 2nd year of treatment","Injection number (up to 4 years of treatment) — up to 4 years of treatment","Injections interval (up to 4 years of treatment) — up to 4 years of treatment","Most stable injection interval — up to 4 years of treatment","Overall extension interval — up to 4 years of treatment","Covid 19 impact — up to 4 years of treatment","Number of follow-up visits — up to 4 years of treatment","Visual acuity — up to 4 years of treatment","Age — Baseline","Eye lesion type — Baseline","Fluid — Baseline","Fluid — 90 days after baseline","Fluid — once a year up to 4 years of treatment","Date of first symptoms — Baseline","Date of first injection — Baseline","Retinal thickness — up to 4 years of treatment","Treatment regimen — first 12 months of treatment]","Number of patients stopping treatment (12-24 months) — between 12 and 24 months of treatment","Reason for stopping treatment (12-24 months) — between 12 and 24 months of treatment"],"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.","Title supplies longevity context: age-related.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","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/42283","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}