CENTERA
Research type
Research Study
Full title
A multi-center, single-arm, interventional Phase 4 study to evaluate a Treat and Extend regimen of intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion
IRAS ID
205118
Contact name
Clare Bailey
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2014-003193-17
Duration of Study in the UK
2 years, 7 months, 15 days
Research summary
The purpose of this study is to better understand macular oedema secondary to Central retinal vein occlusion (CRVO). CRVO occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular oedema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilise, and in many cases, improve the vision loss related to CRVO.
Although the study drug is already on the market for macular oedema secondary to CRVO, there are no studies available that address the questions of what are useful intervals for treating and assessing patients, how do they differ among patients, and how are criteria applied for retreatment. The purpose of this study is to evaluate the effectiveness, treatment interval, dosage, and safety of the treatment regimen (pattern for administering treatment) in patients with macular oedema secondary to CRVO. In addition, this study will explore new imaging methods for assessing the affected eye.
In patients with CRVO, aflibercept works by blocking the activity of a component of your blood known as vascular endothelial growth factor (VEGF) that normally stimulates the growth of new blood vessels in the eye. When the blood vessel that carries blood away from the retina is blocked, VEGF levels rise, causing leakage into the retina which can lead to macular oedema. By blocking the activity of VEGF, aflibercept reduces the amount of leakage
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0201
Date of REC Opinion
22 Sep 2016
REC opinion
Further Information Favourable Opinion