Phase 2
N=15
Eplerenone for Central Serous Chorioretinopathy
Central Serous Chorioretinopathy
Bottom Line
View on ClinicalTrials.gov: NCT01822561 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Complete Resolution of Subretinal Fluid — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eplerenone 50mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Resolution of Subretinal Fluid |
— | — |
| SECONDARY Change in Macular Thickness |
-26 | — |
| SECONDARY Change in Best Corrected Visual Acuity |
-0.03 | — |
| SECONDARY Change in Subfoveal Choroidal Thickness, Study Eye |
29.8 | — |
| SECONDARY Change in Serum Potassium |
0.11 | — |
Summary
* 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
Eligibility Criteria
Inclusion Criteria
- Age 18 or over
- Ability to give written informed consent
- Presence of sub-retinal fluid under the fovea as seen on OCT
- Diagnosis of Acute or Chronic CSCR:
- Acute CSCR: First presentation to eye clinic with visual symptoms, including decreased vision or visual distortion, and the characteristic appearance of CSCR on examination, fluorescein angiography, and OCT.
- Chronic CSCR: Previous diagnosis of CSCR, persistent subretinal fluid on OCT for more than 3 months after initial presentation to the eye clinic, and 2 mg/dL in men and >1.8 mg/dL in women, or a creatinine clearance <50 mL/min, and during concomitant administration of potassium supplements, potassium-sparing diuretics, and/or potent CYP3A4 inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, Rituximab, tacrolimus or voriconazole).
- Patients with type 2 diabetes will be screened for microalbuminuria with a urinalysis. If microalbuminuria is present, these patients will be excluded.
Data sourced from ClinicalTrials.gov (NCT01822561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.