Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

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Brief Title

Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy


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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT)


Condition

Central Serous Chorioretinopathy

Intervention

Eplerenone

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

April 2014


Primary Completion Date

June 2015

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 97236974361, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02153125

Organization ID

0405-13-TLV


Responsible Party

Principal Investigator

Study Sponsor

Tel-Aviv Sourasky Medical Center


Study Sponsor

, , 


Verification Date

May 2014