NCT04113538

Treat and Extend Analysis Trial With Aflibercept in Wet-AMD

Exploratory and Descriptive Study Evaluating the Efficacy of Aflibercept in Bimonthly Injections Versus the ''Treat and Extend'' Dosing Regimen

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Michel Giunta · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept	Intraocular injection of 2 ml (40mg/ml)

Timeline

• Start date: 2019-07-24
• Primary completion: 2023-01-01
• Completion: 2023-05-01
• First posted: 2019-10-02
• Last updated: 2022-06-14

Locations

1 site across 1 country: Canada