VIOLET
Research type
Research Study
Full title
An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of three different treatment regimens of 2 mg aflibercept administered by intravitreal injections to subjects with diabetic macular edema (DME)
IRAS ID
201923
Contact name
Sobha Sivaprasad
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2014-004938-25
Duration of Study in the UK
1 years, 11 months, 5 days
Research summary
The purpose of this study is to better understand how to treat a specific eye disease, which can affect participants with diabetes, so-called diabetic macular edema (DME). The drug that is used in the study is Aflibercept (Eylea®) and it will be given in three different ways (treatment regimens). The study will include participants that have already completed at least one year of treatment of their DME with Aflibercept and is designed to observe the participants for two more years in order to understand different possible ways to use this drug for a longer time.
Aflibercept is already approved by health authorities for the treatment of this disease but as stated above this study is specifically focusing on the question of the three different treatment regimens, a question that has not been explored before in this manner in a large research study. This research study will therefore evaluate how participants treated with one of the three different regimens compare when it comes to how well they see, how well they tolerate the way they are treated but also which side effects they may experience.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/0513
Date of REC Opinion
7 Jul 2016
REC opinion
Further Information Favourable Opinion