Clinical efficacy and mechanistic evaluation of Eplerenone for central serous chorio-retinopathy – the VICI randomised trial.
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 resolve but some persist for years, recur or affect the second eye.
The cause is unknown although it can occur in families and some genetic changes have been found.
Currently there are no proven treatments for this disease, but there have been some reports of patients having a good response to treatment with a drug called eplerenone which removes the fluid under the retina.
The VICI study will look at the benefit of using eplerenone in the treatment of patients with CSCR. However we do not know for sure how effective this treatment is as it has not been tested in a large group of patients, and it is currently unlicensed for use in the treatment of CSCR.
VICI will be the first randomised, double-masked, placebo-controlled clinical trial to find out if eplerenone with usual care in CSCR is better than placebo treatment with usual care. We hope this will establish the first scientifically proven therapy for CSCR.
To include enough patients to provide an informative result we will perform the study in 20 different hospitals around the United Kingdom and aim to recruit 104 patients (52 patients randomised to each group).
Patients and NHS research support teams have helped design the study and will oversee the conduct of the study. The trial has been carefully costed by a clinical trials unit, taking into consideration NHS Treatment costs.