Clinical efficacy and mechanistic evaluation of Eplerenone for Central serous chorio-retinopathy – the VICI randomised trial.
IRAS ID 198007
REC Reference 16/WA/0069
Chief Investigator Andrew Lotery
Sponsor organisation University Hospital Southampton NHS Foundation Trust
Central serous chorio-retinopathy (CSCR) is a poorly understood eye disease. It affects the eye tissue which senses light (the retina). In CSCR fluid spontaneously gathers under the retina. This can lead to permanent vision loss in about a third of cases. Some cases spontaneously resolve but some persist for years, recur or affect the second eye. Each year there are 10 new cases per 100,000 men and 2 cases per 100,000 women in the population. The cause is unknown although it can occur in families and some genetic changes have been found. There are no proven treatments. Recently a few patients have responded to treatment with a drug called eplerenone. This drug removes the subretinal fluid and improves vision. However, information on the long term benefit and safety of this drug is lacking. To address this we will perform the first randomised, double-masked, placebo-controlled clinical trial of eplerenone in CSCR to find out whether it is better than placebo treatment. We hope this will establish the first scientifically proven therapy for CSCR. We will also collect blood samples for future study. This will allow us to study proteins and chemicals in the blood stream and also DNA. With further funding we will determine a) what genetic variations are more common in CSCR patients and b) which proteins or genetic variations help predict who best responds to treatment with eplerenone. It is important to collect these samples now so we have them available for future study. The aim is to recruit 104 patients and to randomise 52 patients to each arm. They will either be treated with a daily tablet called eplerenone, or an identical placebo tablet for up to twelve months. The most important comparison is how much vision improves with eplerenone compared to placebo.
This project is funded by the National Institute for Health Research Efficacy and Mechanism Evaluation (EME) Programme (project number 13/94/15)