Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

Phase 2

• Conditions: Central Serous Chorioretinopathy
• Interventions: Drug: Eplerenone

• Registration Number: NCT02153125
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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

* 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

Study Timeline

• Study Start: 2014-04
• Status Verified: 2014-05
• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-02
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT)	6 months

Trial Locations

Locations (1)

Tel Aviv Souraski Medical Center; 🇮🇱 Tel Aviv, Israel