Eplerenone for the Treatment of Central Serous Chorioretinopathy

Wills Eye

Status: Completed

Conditions: Central Serous Chorioretinopathy

Treatments: Drug: 25mg Eplerenone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01990677

ECSelsior

ESCelsior2013 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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108 participants in 4 patient groups, including a placebo group

25mg Eplerenone- Chronic CSCR Diagnosis

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: 25mg Eplerenone

Placebo- Chronic CSCR Diagnosis

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

25mg Eplerenone- Acute CSCR Diagnosis

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: 25mg Eplerenone

Placebo- Acute CSCR Diagnosis.

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo