Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Brief Summary

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The aim of the study is to determine the efficacy and safety in treating patients with chronic central serous chorioretinopathy with the drug eplerenone.

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Detailed Description

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* The goal of the study is to examine the short-term effects and safety of eplerenone, a systemic anti-aldosterone medication, in a group of patients with central serous chorioretinopathy (CSCR).
* There is currently no standard treatment or therapy for chronic CSCR, a potentially debilitating eye disease.
* There is evidence that high blood serum corticosteroid levels can cause or worsen CSCR
* Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR
* The study's aim is to evaluate a standardized dose of eplerenone in a controlled prospective fashion for chronic CSCR.
* The study consists of taking a standard dose of eplerenone, 25mg once daily for a week, followed by 50mg once daily, for a total of 3 months
* Patients will be monitored for efficacy and side effects from the beginning of treatment and for 6 months

Conditions

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Central Serous Chorioretinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eplerenone

25mg eplerenone given daily for a week, followed by 50mg given for a total of 3 months since commencement of treatment

Group Type EXPERIMENTAL

Eplerenone

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Eplerenone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic central serous chorioretinopathy (CSCR): Previous diagnosis of CSCR, persistent subretinal fluid on OCT for more than 4 months after initial presentation to the eye clinic

Exclusion Criteria

* Other retinal disease
* Choroidal neovascularization
* Diabetes
* A history of uveitis
* Ocular surgery in the prior 3 months
* Allergy to fluorescein or indocyanine green
* Pregnancy, lactation or female patients in fertility age not treated with contraceptive pills
* Creatinine clearance \< 50 ml/min
* Hyperkalemia \> 5 mmol/l
* Patients treated with drugs deactivated by cytochrome P450 3A4 (CYP3A4)
* Serum creatinine \> 2 mg/dl in men or \> 1.8 mg/dl in women
* Treatment with potassium sparing agents or potassium
* Treatment with Angiotensin converting enzyme (ACE)/angiotensin II receptor blocker (ARB) inhibitors

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No