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Treat and Extend Analysis Trial With Aflibercept in Wet-AMD

NCT04113538 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-14

No results posted yet for this study

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

Interventions

DRUG

Aflibercept

Intraocular injection of 2 ml (40mg/ml)

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Michel Giunta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2023-01-31
Completion
2023-05-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113538 on ClinicalTrials.gov