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

Détails

ID Serval
serval:BIB_D7FD075C9638
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Clinical efficacy of eplerenone versus placebo for central serous chorioretinopathy: study protocol for the VICI randomised controlled trial.
Périodique
Eye
Auteur⸱e⸱s
Willcox A., Culliford L., Ellis L., Rogers C.A., Cree A., Chakravarthy U., Ennis S., Behar-Cohen F., Reeves B.C., Sivaprasad S., Lotery A.
ISSN
1476-5454 (Electronic)
ISSN-L
0950-222X
Statut éditorial
Publié
Date de publication
02/2019
Peer-reviewed
Oui
Volume
33
Numéro
2
Pages
295-303
Langue
anglais
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Résumé
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.
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.
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.
Mots-clé
Administration, Oral, Adult, Central Serous Chorioretinopathy/diagnosis, Central Serous Chorioretinopathy/drug therapy, Central Serous Chorioretinopathy/physiopathology, Double-Blind Method, Eplerenone/therapeutic use, Female, Fluorescein Angiography, Humans, Male, Medication Adherence, Middle Aged, Mineralocorticoid Receptor Antagonists/therapeutic use, Placebos, Quality of Life, Subretinal Fluid, Tomography, Optical Coherence, Treatment Outcome, Visual Acuity/physiology, Young Adult
Pubmed
Web of science
Création de la notice
19/09/2018 13:19
Dernière modification de la notice
20/08/2019 16:57
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