Eplerenone for the Treatment of Central Serous Chorioretinopathy

Not Applicable

Completed

Conditions: Central Serous Chorioretinopathy

Interventions: Drug: 25mg Eplerenone
Drug: Placebo

Registration Number: NCT01990677

Lead Sponsor: Wills Eye

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

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
25mg Eplerenone- Acute CSCR Diagnosis	25mg Eplerenone	Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
25mg Eplerenone- Chronic CSCR Diagnosis	25mg Eplerenone	Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
25mg Eplerenone- Chronic CSCR Diagnosis	Placebo	Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
Placebo- Chronic CSCR Diagnosis	Placebo	Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
25mg Eplerenone- Acute CSCR Diagnosis	Placebo	Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
Placebo- Acute CSCR Diagnosis.	Placebo	Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 28 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.

Primary Outcome Measures

Name	Time	Method
Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.	Baseline and 2 months	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Subfoveal Fluid Height Based on OCT Measurement	Baseline and Month 2	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.