{"type":"trials","record":{"id":42254,"source_id":"clinicaltrials-gov","external_id":"NCT04113538","title":"Treat and Extend Analysis Trial With Aflibercept in Wet-AMD","brief_summary":"This study is a randomized, prospective, exploratory, descriptive, open label, parallel group, post-authorization study designed to describe and evaluate two aflibercept treatment regimens aimed at achieving and maintaining a maximum visual function benefit (i.e., BCVA stability). The goal of the study is to compare two strategies for dosing regimen with aflibercept in wet AMD: the standard regimen (one injection every 8 weeks after 3 monthly loading doses in the treatment of wet age-related macular degeneration) versus the treat and extend protocol (details outlined below in the \"Study Design\" section) aiming at achieving and maintaining maximum visual acuity benefit while minimizing the number of injections. Patients will be randomized at week 8 (Month 2) in a proportion of 1:2 (Standard treatment : treat and extend treatment). We aim to demonstrate that the Treat and Extend regimen is equivalent or better to the standard fixed interval regimen in terms of change in patients' visual acuity after a year of treatment and that patients in the Treat and Extend arm will receive fewer injections and fewer visits, than their counterparts in the standard regimen arm. The results could be used to generate a base for future controlled-randomized clinical trials on the timing of treatment administration for patients with wAMD.","overall_status":"Unknown","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Michel Giunta","enrollment":40,"countries":["Canada"],"start_date":"2019-07-24","completion_date":"2023-05-01","last_update_date":"2022-06-14","source_url":"https://clinicaltrials.gov/study/NCT04113538","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Unknown. 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":"Standard","organization":"GOGiunta","interventions":["Aflibercept"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Best Corrected Visual Acuity — from baseline to week 52 (Month 12)","Injections — from baseline to week 52 (Month 12)","Treatment-free intervals — from baseline to week 52 (Month 12)","Gain of letters — from baseline to week 52 (Month 12)","Loss of letters — from baseline to week 52 (Month 12)"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Wet Age-related Macular Degeneration","Aflibercept"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04113538","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-07-24 to 2023-05-01","comparator":"Standard","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":"2026-09-25T06:20:47.941Z","intervention":["Aflibercept"],"participants":40,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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":["Best Corrected Visual Acuity — from baseline to week 52 (Month 12)","Injections — from baseline to week 52 (Month 12)","Treatment-free intervals — from baseline to week 52 (Month 12)","Gain of letters — from baseline to week 52 (Month 12)","Loss of letters — from baseline to week 52 (Month 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":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/42254","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}