Status:
COMPLETED
Eplerenone for Central Serous Chorioretinopathy
Lead Sponsor:
Tufts Medical Center
Conditions:
Central Serous Chorioretinopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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)...
Detailed Description
* 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 ...
Eligibility Criteria
Inclusion
- 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 \<50% reduction in fluid thickness on OCT after 3 months. Patients who have had previous treatment for CSCR may be included.
Exclusion
- Age less than 18
- Persons with impaired decision-making ability.
- Women who are known to be pregnant or are actively trying to conceive.
- Additional eye disease affecting the macula or posterior retina.
- At screening, serum potassium concentration ≥5.0 mEq/L , a serum creatinine concentration \>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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01822561
Start Date
May 1 2013
End Date
December 1 2017
Last Update
May 16 2018
Active Locations (1)
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1
New England Eye Center / Tufts Medical Center
Boston, Massachusetts, United States, 02111