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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01990677
Other study ID # ECSelsior
Secondary ID ESCelsior2013
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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