Central Serous Chorioretinopathy
Conditions
Brief summary
The aim of the study is to determine the efficacy and safety in treating patients with chronic central serous chorioretinopathy with the drug eplerenone.
Detailed description
* The goal of the study is to examine the short-term effects and safety of eplerenone, a systemic anti-aldosterone medication, in a group of patients with central serous chorioretinopathy (CSCR). * There is currently no standard treatment or therapy for chronic CSCR, a potentially debilitating eye disease. * There is evidence that high blood serum corticosteroid levels can cause or worsen CSCR * 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 study's aim is to evaluate a standardized dose of eplerenone in a controlled prospective fashion for chronic CSCR. * The study consists of taking a standard dose of eplerenone, 25mg once daily for a week, followed by 50mg once daily, for a total of 3 months * Patients will be monitored for efficacy and side effects from the beginning of treatment and for 6 months
Interventions
DRUGEplerenone
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic central serous chorioretinopathy (CSCR): Previous diagnosis of CSCR, persistent subretinal fluid on OCT for more than 4 months after initial presentation to the eye clinic
Exclusion criteria
* Other retinal disease * Choroidal neovascularization * Diabetes * A history of uveitis * Ocular surgery in the prior 3 months * Allergy to fluorescein or indocyanine green * Pregnancy, lactation or female patients in fertility age not treated with contraceptive pills * Creatinine clearance \< 50 ml/min * Hyperkalemia \> 5 mmol/l * Patients treated with drugs deactivated by cytochrome P450 3A4 (CYP3A4) * Serum creatinine \> 2 mg/dl in men or \> 1.8 mg/dl in women * Treatment with potassium sparing agents or potassium * Treatment with Angiotensin converting enzyme (ACE)/angiotensin II receptor blocker (ARB) inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT) | 6 months |
Countries
Israel
Contacts
Primary ContactMichaella Goldstein, MD
Outcome results
None listed