N/A
N=18
Eplerenone for the Treatment of Central Serous Chorioretinopathy
Central Serous Chorioretinopathy
Bottom Line
View on ClinicalTrials.gov: NCT01990677 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. — 139.3; 135.9; 51.8; 172.3 microns
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 25mg Eplerenone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. |
139.3; 135.9; 51.8; 172.3 | — |
| SECONDARY Mean Change in Subfoveal Fluid Height Based on OCT Measurement |
121.4; 92.1; 29.4; 134.0 | — |
Summary
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .
Eligibility Criteria
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
- Acute- first episode or symptoms less than one month prior to presentation
- Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or 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
Data sourced from ClinicalTrials.gov (NCT01990677). 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.