AQUA
Research type
Research Study
Full title
Open-label Phase-4 study to examine the change of vision-related quality of life in subjects with diabetic macular edema (DME) during treatment with intravitreal injections of 2 mg aflibercept according to EU label for the first year of treatment.
IRAS ID
182526
Contact name
Sobha Sivaprasad
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2014-005119-17
Duration of Study in the UK
1 years, 10 months, 24 days
Research summary
This study is taking place to find out more about how well patient can see when they are suffering from diabetic macular edema (DME) and are being treated with Aflibercept (Eylea®). This is a drug has received approval to treat this condition. The purpose of this study is to assess the vision quality of life while patient are having this treatment.
There are three (3) parts to this study: the Screening Period, the Treatment Period and the End-of-Treatment Visit. Participants will take part in the study for a maximum of 56 weeks (13 months). It is expected that they will receive treatment in the study for up to 48 weeks (11 months), and that they will attend a screening visit(s) at the beginning plus an end of treatment visit at the end.
During the study the participant will be required to give blood and urine samples. They will go through different types of assessments involving their vision and asked to complete questionnaires.REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1015
Date of REC Opinion
22 Oct 2015
REC opinion
Further Information Favourable Opinion