Eplerenone for Central Serous Chorioretinopathy
This study is currently recruiting participants.
Verified December 2013 by Tufts Medical Center
Tufts Medical Center
Information provided by (Responsible Party):
Tufts Medical Center
First received: March 25, 2013
Last updated: December 10, 2013
Last verified: December 2013
- The goal of the study is to examine the short-term effects and safety of a systemic anti-aldosterone medication, eplerenone, in a small group of patients with central serous chorioretinopathy (CSCR).
- There is currently no standard treatment or therapy for either acute or chronic CSCR, a potentially debilitating eye disease.
- There is evidence in both animals and humans that high blood serum corticosteroid levels can cause or worsen CSCR or findings similar to CSCR in the choroid and retina
- Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR
- The investigators' aim is to evaluate a standardized dose of eplerenone in a controlled prospective fashion for both acute and chronic CSCR.
- The study consists of taking a standard dose of eplerenone, 50mg once daily, for 1 month
- Over the course of the month, patients will be monitored for side effects, as well as visual and anatomical response to the medication
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Eplerenone for Central Serous Chorioretinopathy: A Pilot Study|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Tufts Medical Center:
Primary Outcome Measures:
- Resolution of Sub-retinal Fluid [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: No ]Optical coherence tomography (OCT) is an imaging technique capable of extremely high resolution (~5-7 microns) imaging of the macula, and is able to detect the presence and amount of subretinal fluid present, the key anatomic abnormality in Central Serous Chorioretinopathy
Secondary Outcome Measures:
- Change in macular thickness [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: No ]Automated software to calculate the thickness of the macula is standard on commercial OCT devices. Macular thickness before and after treatment will be assessed and compared.
- Best Corrected Visual Acuity [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: No ]Visual acuity will be measured with standard ETDRS eye charts, with manifest refraction at the initiation and conclusion of treatment. Although an important measure, this was not chosen as the primary outcome measure, as some patients with central serous chorioretinopathy may have a normal visual acuity when properly refracted (refraction can change with elevation of the macula by sub-retinal fluid)
- Change in choroidal thickness, both eyes [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: No ]Choroidal thickness can be measured using OCT, and is known to be affected in patients with central serous chorioretinopathy. OCT characteristics may be affected in the fellow eye. Thickness of the choroid under the fovea will be manually calculated in both the study eye and the fellow eye.
- Safety and Tolerability Characteristics [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: Yes ]Eplerenone can cause elevation of serum potassium, cholesterol, and LFT's, as well as decrease the blood pressure. After initial screening, serum potassium and creatinine will be evaluated at 1 and 4 weeks after baseline. Additional serum tests of electrolytes, liver function tests, uric acid, and a fasting cholesterol panel will be obtained before treatment and 4 weeks after baseline. Adverse and Serious Adverse Events will be recorded and reported to the Institutional Review Board.
|Study Start Date:||May 2013|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
All patients in this study will receive Eplerenone 50mg once daily for 4 weeks.
Drug: Eplerenone 50mg
All patients will receive the same dose of eplerenone.
- The investigators hypothesize that aldosterone inhibition with eplerenone will decrease choroidal vessel vasodilation, focal leakage, and choroidal thickness in patients with both acute and chronic CSCR, leading to resolution of subretinal fluid and ultimately an improvement in symptoms.
- Resolution of sub-retinal fluid will be the primary outcome, which can be precisely measured using optical coherence tomography (OCT)
- Secondary outcomes will include: Change in macular thickness measured with OCT, in central macular circle thickness on OCT, change in visual acuity, change in dye leakage characteristics on fluorescein angiography, change in OCT characteristics of the fellow eye, and safety and tolerability characteristics
- In acute CSCR, subretinal fluid often resolves on its own, but it often takes several months (the literature shows that ~20% of patients have complete resolution of sub-retinal fluid on OCT 1 month after presentation)
- Chronic CSCR is defined as persistent fluid on OCT after 3 months of symptom onset, or recurrence of signs and symptoms within 1 year after the prior episode
- In this study, the investigators will not make a distinction between acute and chronic CSCR
- Eplerenone, a generic medication, is a potassium sparing diuretic, which is FDA approved to treat heart failure as well as high blood pressure, but is not FDA approved for treatment of central serous chorioretinopathy.
- The most important side effect of eplerenone is elevation of serum potassium and decrease of blood pressure
- Patients will therefore be screened with routine blood tests as suggested by the package insert of the medication, and serum potassium and blood pressure will be monitored routinely as directed by the medication package insert
- Study visits will be performed at therapy initiation, 1 week, 2 weeks, and 4 weeks
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822561
|United States, Massachusetts|
|New England Eye Center / Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Andre J Witkin, MD 617-646-7950 firstname.lastname@example.org|
|Contact: Julie Burt 617-636-0747 email@example.com|
|Principal Investigator: Andre J Witkin, MD|
|Sub-Investigator: Jay S Duker, MD|
|Sub-Investigator: Elias Reichel, MD|
|Sub-Investigator: Caroline R Baumal, MD|
|Sub-Investigator: Adam R Rogers, MD|
|Sub-Investigator: Nadia K Waheed, MD|
|Sub-Investigator: Roger Goldberg, MD|
|Sub-Investigator: Marissa Weber, MD|
|Sub-Investigator: Jordana Fein, MD|
Sponsors and Collaborators
Tufts Medical Center