The Bluebelle Phase B results paper has been published which brings the total number of papers from this feasibility study to ten!
The Bristol Trials Centre recently published the results of one of the clinical trials managed by the Centre in The Lancet. The VICI Trial investigated the safety and efficacy of a heart drug, eplerenone, for treating an eye condition called chronic central serous retinopathy (CSCR). Eplerenone is licenced to treat heart failure but is widely prescribed for chronic CSCR despite limited evidence of its efficacy. In this blinded, placebo-controlled randomised trial, 114 participants were assigned to take tablets containing either eplerenone or a placebo once daily for up to 12 months, with regular hospital visits to have assessments of their vision, eye anatomy and quality of life. The primary outcome was visual acuity (i.e. ability to read letters on a letter chart) at 12 months.
The results showed that participants in the eplerenone group did no better than those in the placebo group in any of the outcomes assessed. Therefore, there is no benefit of taking eplerenone for the treatment of chronic CSCR. This was an important finding as eplerenone is currently being used widely to treat this condition with no proven benefit. Our aim now is to ensure the results are disseminated far and wide to stop the prescribing of eplerenone for chronic CSCR before it becomes embedded in practice.
The results of the trial have been fed back to participants via a results summary leaflet and, in addition to the Lancet paper, we have disseminated the results in other formats to ensure that the headline result is communicated to as many people as possible: an animated video created for YouTube has generated a lot of interest, and a summary infographic has been created for dissemination to professional groups at conferences and training events. We have also publicised the trial widely through the BTC twitter account @BrsTrialsCentre.
Chief investigator: Prof Andrew Lotery, consultant ophthalmologist, University of Southampton
Sponsor: University Hospitals Southampton NHS Trust. This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme (13/94/15), an MRC and NIHR partnership. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care.