Clinical efficacy of eplerenone versus placebo for central serous chorioretinopathy: study protocol for the VICI randomised controlled trial

Abstract

Aims: Chronic central serous chorioretinopathy (CSCR) is poorly understood. Fluid accumulates in the subretinal space and retinal pigment epitheliopathy and neurosensory atrophy may develop. Permanent vision loss occurs in approximately one third of cases. There are no effective treatments for CSCR. Recent studies have shown the mineralocorticoid receptor antagonist, eplerenone, to be effective in resolving subretinal fluid and improving visual acuity. This trial aims to compare the safety and efficacy of eplerenone in patients with CSCR in a double-masked randomised placebo-controlled trial.

Methods: Patients are randomised 1:1 to receive eplerenone with usual care or placebo with usual care for 12 months; 25 mg per day for 1 week, then 50 mg per day up to 12 months (unless discontinued for safety or resolution of CSCR). Key eligibility criteria are: age 18-60 years, one eye with CSCR for ≥4 months duration, best-corrected visual acuity (BCVA) >53 and <86 letters and no previous treatment. The primary outcome is BCVA at 12 months. Secondary outcomes include resolution of subretinal fluid, development of macular atrophy, subfoveal choroidal thickness, changes in low luminance visual acuity, health-related quality of life and safety.

Conclusions: Recruitment is complete but was slower than expected. We maintained the eligibility criteria to ensure participants had 'true' CSCR and recruited additional centres. Effective distribution of the investigational medicinal product (IMP) was achieved by implementing a database to manage ordering and accountability of IMP packs. The results will provide adequately powered evidence to inform clinical decisions about using eplerenone to treat patients with CSCR.

Fig. 1

Trial schema showing the recruitment pathway, follow-up schedule and assessments

Fig. 2

SPIRIT diagram of trial time-points and data collection schedule. Trial time-points and data collection schedule. Timepoints: −t₁ = baseline; t₁ = week 1 (±1 day); t₂ = week 4 (±5 days); t₃ = 3 months (±10 days); t₄ = 6 months (± 10 days); t₅ = 9 months (±10 days); t₆ = 12 months (±10 days). BCVA best-corrected visual acuity, EDI enhanced depth imaging, NEI National Eye Institute. *1 At each visit we will check whether patients are taking any drugs that have been shown to treat CSCR (e.g. rifampicin, finasteride, melatonin). *2 Images at baseline and 12 months to be graded by independent reading centre at Network of Ophthalmic Reading Centres UK. Images from other at time-points to be graded by specialists within the study team. *3 Where equipment is available. *4 Samples sent to the University of Southampton hospital laboratory to store in the biobank. *5 Tests conducted at local hospitals. *6 To include creatinine