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Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

Primary Purpose

Central Serous Chorioretinopathy

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tel Aviv Souraski Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eplerenone

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2014
Last Updated
May 30, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02153125
Brief Title
Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone
Arm Type
Experimental
Arm Description
25mg eplerenone given daily for a week, followed by 50mg given for a total of 3 months since commencement of treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Primary Outcome Measure Information:
Title
Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michaella Goldstein, MD
Phone
97236974361
Email
michgold@netvision.net.il
Facility Information:
Facility Name
Tel Aviv Souraski Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaella Goldstein, MD
First Name & Middle Initial & Last Name & Degree
Roy Schwartz, MD
First Name & Middle Initial & Last Name & Degree
Michael Martinez, MD
First Name & Middle Initial & Last Name & Degree
Zohar Wilner, MD
First Name & Middle Initial & Last Name & Degree
Shiri Shulman, MD
First Name & Middle Initial & Last Name & Degree
Oded Ohana, MD
First Name & Middle Initial & Last Name & Degree
Shay Keren, MD
First Name & Middle Initial & Last Name & Degree
Dafna Goldenberg, MD
First Name & Middle Initial & Last Name & Degree
Meira Neuderfer, MD
First Name & Middle Initial & Last Name & Degree
Chanan Guzner-Gur, MD
First Name & Middle Initial & Last Name & Degree
Amir Nutman, MD
First Name & Middle Initial & Last Name & Degree
Anat Loewenstein, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22684104
Citation
Zhao M, Celerier I, Bousquet E, Jeanny JC, Jonet L, Savoldelli M, Offret O, Curan A, Farman N, Jaisser F, Behar-Cohen F. Mineralocorticoid receptor is involved in rat and human ocular chorioretinopathy. J Clin Invest. 2012 Jul;122(7):2672-9. doi: 10.1172/JCI61427. Epub 2012 Jun 11.
Results Reference
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PubMed Identifier
20930852
Citation
Gemenetzi M, De Salvo G, Lotery AJ. Central serous chorioretinopathy: an update on pathogenesis and treatment. Eye (Lond). 2010 Dec;24(12):1743-56. doi: 10.1038/eye.2010.130. Epub 2010 Oct 8.
Results Reference
background
PubMed Identifier
18538401
Citation
Chan WM, Lai TY, Lai RY, Liu DT, Lam DS. Half-dose verteporfin photodynamic therapy for acute central serous chorioretinopathy: one-year results of a randomized controlled trial. Ophthalmology. 2008 Oct;115(10):1756-65. doi: 10.1016/j.ophtha.2008.04.014. Epub 2008 Jun 5.
Results Reference
background
PubMed Identifier
19896635
Citation
Reibaldi M, Cardascia N, Longo A, Furino C, Avitabile T, Faro S, Sanfilippo M, Russo A, Uva MG, Munno F, Cannemi V, Zagari M, Boscia F. Standard-fluence versus low-fluence photodynamic therapy in chronic central serous chorioretinopathy: a nonrandomized clinical trial. Am J Ophthalmol. 2010 Feb;149(2):307-315.e2. doi: 10.1016/j.ajo.2009.08.026. Epub 2009 Nov 6.
Results Reference
background
PubMed Identifier
6682293
Citation
Robertson DM, Ilstrup D. Direct, indirect, and sham laser photocoagulation in the management of central serous chorioretinopathy. Am J Ophthalmol. 1983 Apr;95(4):457-66. doi: 10.1016/0002-9394(83)90265-9.
Results Reference
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Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

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