A clinical research study published in The Lancet has reported that the treatment of eplerenone should be discontinued for the use of serous chorioretinopathy (CSCR) in ophthalmic practice. An analysis of the study reported that both primary and secondary outcomes of the trial indicated that there was no benefit of eplerenone treatment over placebo. Following the research, a commentary on the report stated that: “This result is an important outcome that will change clinical practice. The trial results should prompt ophthalmologists to stop prescribing eplerenone to treat CSCR and encourage patients to participate in future trials of other potential interventions.” The study was led by Prof. Andrew Lotery at the University of Southampton, and Prof. Sobha Sivaprasad at the Moorfields Eye Hospital NHS Foundation Trust, UK.
The aetiology of central serous chorioretinopathy (CSR) has an estimated 10 new cases per 100,000 men and 2 cases per 100,000 women in the population however, there is no clear cause. Pathological features include hyperpermeability, fluid accumulation, RPE detachment, the disruption of outer blood-retinal barrier and subsequent detachment of the sensory retina. As there was no proven treatment, a randomised, double-blind, placebo-controlled study had either eplerenone (25 mg/day for 1 week, increasing to 50 mg/day for up to 12 months) or the placebo group (1:1). The study was a superiority trial conducted in 22 UK National Health Service secondary care hospitals. One hundred and fourteen (114) patients received either eplerenone (n=57) or placebo (n=57), (after three participants withdrew consent in the placebo group). After the analysis, mean BCVA at 12 months was 79·5 letters (SD 4·5) in the placebo group and 80·4 letters (4·6) in the eplerenone group, with an adjusted estimated mean difference of 1·73 letters (95% CI –1·12 to 4·57; p=0·24) at 12 months. In addition, hyperkalaemia occurred in eight (14%) patients in each group.
In addition to the primary outcome, the secondary outcomes included low luminance visual acuity testing, vision-associated quality of life (Visual Function Questionnaire-25) assessment, an estimated median time to complete resolution of subretinal fluid, choroidal thickness, subretinal fluid thickness, and estimated median time to CSCR recurrence. Following the results, the outcomes did not favour eplerenone. In a commentary to the paper in The Lancet, independent reviewers stated that: “Overall, the study by Lotery and colleagues is a well designed clinical trial providing a clear answer: eplerenone shows no benefit over placebo in patients with chronic CSCR. Hence, this drug should not be used for the treatment of patients with CSCR. The study was done at the right time as it has the potential to prevent the consolidation of eplerenone in clinical practice. As clinicians, we should remember the message of the [VICI] trial when treating patients with chronic CSCR.”