Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02153125
• Other study ID #: 0405-13-TLV
• Status: Recruiting
• Phase: Phase 2
• First received: May 29, 2014
• Last updated: May 30, 2014
• Start date: April 2014

Study information

• Verified date: May 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Michaella Goldstein, MD
• Phone: 97236974361
• Email: michgold[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• Eplerenone

Locations

Country	Name	City	State
Israel	Tel Aviv Souraski Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. — View Citation

Zhao M, Célérier 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT)		6 months	No