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

Clinical efficacy of eplerenone versus placebo for central serous chorio-retinopathy: study protocol for the VICI randomised controlled trial
Clinical efficacy of eplerenone versus placebo for central serous chorio-retinopathy: study protocol for the VICI randomised controlled trial
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.
Central serous chorioretinopathy; eplerenone; placebo; randomised controlled trial; masked; sub-retinal gluid: mineralocorticoid receptor antagonist; investigational medicinal product
0950-222X
295-303
Willcox, Abby
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Culliford, Lucy
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Ellis, Lucy
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Rogers, Chris A.
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Cree, Angela
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Chakravarthy, Usha
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Ennis, Sarah
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Behar-Cohen, Francine
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Reeves, Barnaby
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Sivaprasad, Sobha
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Lotery, Andrew
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Willcox, Abby
d3e7418f-2bc7-4fbc-a6ad-79478abc8172
Culliford, Lucy
2ebe9e38-51e1-4390-985a-3519410f3856
Ellis, Lucy
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Rogers, Chris A.
1074c268-aced-471a-95fe-ad3e0067e605
Cree, Angela
6724b71b-8828-4abb-971f-0856c2af555e
Chakravarthy, Usha
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Ennis, Sarah
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Behar-Cohen, Francine
538bbb9e-3afa-46b9-8ace-6d506613153c
Reeves, Barnaby
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Sivaprasad, Sobha
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Lotery, Andrew
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Willcox, Abby, Culliford, Lucy, Ellis, Lucy, Rogers, Chris A., Cree, Angela, Chakravarthy, Usha, Ennis, Sarah, Behar-Cohen, Francine, Reeves, Barnaby, Sivaprasad, Sobha and Lotery, Andrew (2019) Clinical efficacy of eplerenone versus placebo for central serous chorio-retinopathy: study protocol for the VICI randomised controlled trial. Eye, 33 (2), 295-303. (doi:10.1038/s41433-018-0212-2).

Record type: Article

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.

Text
VICI Protocol paper v4.0 merged inc supp mat FINAL accepted - Accepted Manuscript
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More information

Accepted/In Press date: 22 August 2018
e-pub ahead of print date: 7 September 2018
Published date: February 2019
Keywords: Central serous chorioretinopathy; eplerenone; placebo; randomised controlled trial; masked; sub-retinal gluid: mineralocorticoid receptor antagonist; investigational medicinal product

Identifiers

Local EPrints ID: 423781
URI: http://eprints.soton.ac.uk/id/eprint/423781
ISSN: 0950-222X
PURE UUID: e3efbdf5-ff6c-4213-b858-2d609bc4b3d7
ORCID for Sarah Ennis: ORCID iD orcid.org/0000-0003-2648-0869
ORCID for Andrew Lotery: ORCID iD orcid.org/0000-0001-5541-4305

Catalogue record

Date deposited: 01 Oct 2018 16:30
Last modified: 10 Jan 2022 05:21

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Contributors

Author: Abby Willcox
Author: Lucy Culliford
Author: Lucy Ellis
Author: Chris A. Rogers
Author: Angela Cree
Author: Usha Chakravarthy
Author: Sarah Ennis ORCID iD
Author: Francine Behar-Cohen
Author: Barnaby Reeves
Author: Sobha Sivaprasad
Author: Andrew Lotery ORCID iD

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