Treat and Extend Analysis Trial With Aflibercept in Wet-AMD

Sponsor
Michel Giunta
Study ID
NCT04113538
Phase
PHASE3
Status
Unknown

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    Intraocular injection of 2 ml (40mg/ml)

Study Details

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.

Key Dates

Start date
Jul 24, 2019
Status verified
Jun 2022
Primary completion
Jan 31, 2023
Completion
May 31, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard
    2 ml (40 mg/ml) of Eylea solution : loading dose of 3 intravitreal injections every 4 weeks for the first 3 months followed by an injection every 8 weeks until the end of the study
  • Experimental: Treat and Extend
    2 ml (40 mg/ml) of Eylea solution : loading dose of 3 intravitreal injections every 4 weeks for the first 3 months followed and, until the end of the study, retreatment interval based on disease stability

Primary Outcome Measure

Best Corrected Visual Acuity [ Time Frame: from baseline to week 52 (Month 12) ]

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