Treat and Extend Analysis Trial With Aflibercept in Wet-AMD
Status:
Unknown status
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
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.