Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

Study Overview
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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.

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

Intervention / Treatment
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* Drug: Eplerenone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eplerenone<br>25mg eplerenone given daily for a week, followed by 50mg given for a total of 3 months since commencement of treatment | Drug: Eplerenone<br> <br> |
| Placebo Comparator: Placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT) |  | 6 months |