Eplerenone for the Treatment of Central Serous Chorioretinopathy
Information source: Wills Eye
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Central Serous Chorioretinopathy
Intervention: 25mg Eplerenone (Drug); Placebo (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Wills Eye Official(s) and/or principal investigator(s): Jason Hsu, MD, Principal Investigator, Affiliation: Wills Eye Hospital
Summary
To test the effect oral eplerenone versus placebo in patients with central serious
chorioretinopathy .
Clinical Details
Official title: Eplerenone for the Treatment of Central Serous Chorioretinopathy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Absence of sub-foveal (retinal) fluid based on spectral domain optical coherence tomography (OCT) measurement.
Secondary outcome: Mean change in subfoveal fluid height based on OCT measurement
Detailed description:
To evaluate the effect of oral eplerenone compared to placebo in patients with central
serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical
coherence tomography (OCT).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18 and over
- Ability to give written informed consent
- Sub-retinal fluid under fovea seen on OCT
- Diagnosis of CSCR: classification is at the discretion of the investigator, but
general guidelines are
1. Acute- first episode or symptoms less than one month prior to presentation
2. Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms
for over 3 months, or <50% reduction in fluid thickness on OCT after 3 months.
Exclusion Criteria:
- Age under 18
- Impaired decision-making ability
- At initial laboratory screening serum potassium >5. 5 mEq/L (milliequivalent)
- 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
Locations and Contacts
Mid Atlantic Retina, Cherry Hill, New Jersey 08002, United States
Mid Atlantic Retina, Marlton, New Jersey 08053, United States
Mid Atlantic Retina, Mays Landing, New Jersey 08330, United States
Mid Atlantic Retina, Bala Cynwyd, Pennsylvania 19004, United States
Mid Atlantic Retina, Bethlehem, Pennsylvania 18020, United States
Mid Atlantic Retina, Huntingdon Valley, Pennsylvania 19006, United States
Mid Atlantic Retina, Lansdale, Pennsylvania 19446, United States
Mid Atlantic Retina, New Wilmington, Pennsylvania 19803, United States
Mid Atlantic Retina, Newtown Square, Pennsylvania 19073, United States
Mid Atlantic Retina, Plymouth Meeting, Pennsylvania 19462, United States
Additional Information
Starting date: October 2013
Last updated: February 19, 2015
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