{"type":"trials","record":{"id":42291,"source_id":"clinicaltrials-gov","external_id":"NCT04891835","title":"Analysis of naïve Patients With Age-related Macular Degeneration of the Neovascular Type and Treated With Aflibercept (Eylea®) in \"Treat-and-extend\" at CHU Brugmann","brief_summary":"Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50. Neovascular AMD, the most serious and severe form, is characterized by the appearance, spread and growth of subretinal new vessels. One of the major molecular mediators is vascular endothelial growth factor (VEGF). Intra-vitreous (IVI) injection of an anti-VEGF can slow the progression of neovascular AMD and stabilize vision in the majority of cases. Aflibercept (Eylea®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD. At the start of its use, aflibercept was first injected monthly and then according to the PRN \"reactive\" protocol (Pro Renata). Over time, a new treatment strategy has emerged: the \"treat-and-extend\" (T\\&E). This is individualized patient care, the objective of which is to reduce the frequency of injections while ensuring inactivity of the disease. This begins with the loading dose, i.e. 3 injections given 4 weeks apart. Thereafter, the interval is lengthened in increments 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 IVI. The efficacy and safety of aflibercept, when used in a proactive T\\&E regimen, was demonstrated in the randomized controlled trial, ALTAIR. However, data on T\\&E used in practice is still lacking. routine, and particularly the number of injections and treatment intervals over a minimum 24 month treatment period. The aim of this retrospective study carried out at the CHU Brugmann is to determine the number of injections and the intervals necessary to have encouraging results in terms of visual acuity, over a treatment period of at least one year.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Laurence Postelmans","enrollment":36,"countries":["Belgium"],"start_date":"2021-04-13","completion_date":"2021-09-22","last_update_date":"2022-03-08","source_url":"https://clinicaltrials.gov/study/NCT04891835","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 — 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","Number of patients stopping treatment (24-36 months) — between 24 and 36 months of treatment","Reason for stopping treatment (24-36 months) — between 24 and 36 months of treatment"],"design_description":null,"source_has_results":false},"controlled_terms":["Age-related 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:nct04891835","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":"2026-09-25T06:20:47.947Z","intervention":["Data extraction from medical files"],"participants":36,"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 — 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","Number of patients stopping treatment (24-36 months) — between 24 and 36 months of treatment","Reason for stopping treatment (24-36 months) — between 24 and 36 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.","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/42291","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}