Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2

Conditions: Central Serous Chorioretinopathy

Treatments: Drug: Eplerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT02153125

0405-13-TLV

Details and patient eligibility

About

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

Full description

• 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Eplerenone

Experimental group

Description:

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

Treatment:

Drug: Eplerenone

Placebo

Placebo Comparator group