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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

Page last updated: August 23, 2015

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