Overview

This trial is active, not recruiting.

Condition central serous chorioretinopathy
Treatments 25mg eplerenone, placebo
Sponsor Wills Eye
Start date October 2013
End date March 2015
Trial size 108 participants
Trial identifier NCT01990677, ECSelsior, ESCelsior2013

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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 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 Sugar pill
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.
(Placebo Comparator)
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.
placebo Sugar pill
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.
(Active Comparator)
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 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 Sugar pill
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.
(Active Comparator)
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.
placebo Sugar pill
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.

Primary Outcomes

Measure
Absence of sub-foveal (retinal) fluid based on spectral domain optical coherence tomography (OCT) measurement.
time frame: At 1 month in acute CSCR and 2 months in chronic CSR patients

Secondary Outcomes

Measure
Mean change in subfoveal fluid height based on OCT measurement
time frame: Month 1 for acute CSCR patients, Month 2 in chronic CSCR patients

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age 18 and over - Ability to give written informed consent - Sub-retinal fluid under fovea seen on OCT - Diagnosis of 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 mEq/L (milliequivalent) - 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

Additional Information

Official title Eplerenone for the Treatment of Central Serous Chorioretinopathy
Principal investigator Jason Hsu, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Wills Eye.