Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

May 30, 2014 updated by: Michaella Goldstein, Tel-Aviv Sourasky Medical Center
The aim of the study is to determine the efficacy and safety in treating patients with chronic central serous chorioretinopathy with the drug eplerenone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Souraski Medical Center
        • Principal Investigator:
          • Michaella Goldstein, MD
        • Sub-Investigator:
          • Roy Schwartz, MD
        • Sub-Investigator:
          • Michael Martinez, MD
        • Sub-Investigator:
          • Zohar Wilner, MD
        • Sub-Investigator:
          • Shiri Shulman, MD
        • Sub-Investigator:
          • Oded Ohana, MD
        • Sub-Investigator:
          • Shay Keren, MD
        • Sub-Investigator:
          • Dafna Goldenberg, MD
        • Sub-Investigator:
          • Meira Neuderfer, MD
        • Sub-Investigator:
          • Chanan Guzner-Gur, MD
        • Sub-Investigator:
          • Amir Nutman, MD
        • Sub-Investigator:
          • Anat Loewenstein, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
EXPERIMENTAL: Eplerenone
25mg eplerenone given daily for a week, followed by 50mg given for a total of 3 months since commencement of treatment
Drug: Eplerenone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (ESTIMATE)

June 2, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0405-13-TLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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