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Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

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ClinicalTrials.gov Identifier: NCT02153125
Recruitment Status : Unknown
Verified May 2014 by Michaella Goldstein, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Michaella Goldstein, 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.

Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Drug: Eplerenone Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2014
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
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
Placebo Comparator: Placebo



Primary Outcome Measures :
  1. Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153125


Contacts
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Contact: Michaella Goldstein, MD 97236974361 michgold@netvision.net.il

Locations
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Israel
Tel Aviv Souraski Medical Center Recruiting
Tel Aviv, Israel, 64239
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         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Publications:
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Responsible Party: Michaella Goldstein, Deputy Head Department of Ophthalmology, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02153125     History of Changes
Other Study ID Numbers: 0405-13-TLV
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents