Eplerenone for the Treatment of Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Clinical Trial

Official title:

Eplerenone for the Treatment of Central Serous Chorioretinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990677
• Other study ID #: ECSelsior
• Secondary ID: ESCelsior2013
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

Description:

To evaluate the effect of oral eplerenone compared to placebo in patients with central serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical coherence tomography (OCT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and over

• Ability to give written informed consent

• Sub-retinal fluid under fovea seen on OCT

• Diagnosis of central serous chorioretinopathy (CSCR): classification is at the discretion of the investigator, but general guidelines are

1. Acute- first episode or symptoms less than one month prior to presentation

2. Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or <50% reduction in fluid thickness on OCT after 3 months.

Exclusion Criteria:

• Age under 18

• Impaired decision-making ability

• At initial laboratory screening serum potassium >5.5 milliequivalent (mEq)/L

• At initial laboratory screening serum creatinine >2 mg/dL in men and >1.8 mg/dL in women or decreased renal function by creatinine clearance less than 50 mL/min

• Absence of sub-foveal fluid

• Any patient with prior treatment for CSCR within 3 months of enrollment

• Patients taking potassium supplements or potassium-sparing diuretics spironolactone, amiloride, and triamterene and/or potent CYP3A4 (cytochrome) inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, rituximab, tacrolimus, voriconazole nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir)

• Women who are pregnant or are actively trying to conceive

• Patients with type 1 or type 2 diabetes

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• 25mg Eplerenone
Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
• Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.

Locations

Country	Name	City	State
United States	Mid Atlantic Retina	Bala-Cynwyd	Pennsylvania
United States	Mid Atlantic Retina	Bethlehem	Pennsylvania
United States	Mid Atlantic Retina	Cherry Hill	New Jersey
United States	Mid Atlantic Retina	Huntingdon Valley	Pennsylvania
United States	Mid Atlantic Retina	Lansdale	Pennsylvania
United States	Mid Atlantic Retina	Marlton	New Jersey
United States	Mid Atlantic Retina	Mays Landing	New Jersey
United States	Mid Atlantic Retina	New Wilmington	Pennsylvania
United States	Mid Atlantic Retina	Newtown Square	Pennsylvania
United States	Mid Atlantic Retina	Plymouth Meeting	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Mid Atlantic Retina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT	Proportion of eyes having a decrease in subretinal fluid on spectral domain OCT from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.	Baseline and Month 2
Primary	Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.	Mean change in maximal subretinal fluid height based on spectral domain OCT from baseline to month 2 in chronic central serous chorioretinopathy (CSCR) patients receiving placebo versus eplerenone.	Baseline and 2 months
Secondary	Mean Change in Subfoveal Fluid Height Based on OCT Measurement	Mean change in subfoveal fluid height based on spectral domain OCT measurement from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.	Baseline and Month 2