Eplerenone for the Treatment of Central Serous Chorioretinopathy

Brief Title

Eplerenone for the Treatment of Central Serous Chorioretinopathy

Official Title

Eplerenone for the Treatment of Central Serous Chorioretinopathy

Brief Summary

      To test the effect oral eplerenone versus placebo in patients with central serious
      chorioretinopathy .
    

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).
    

Study Type

Interventional

Primary Outcome

Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.

Secondary Outcome

 Mean Change in Subfoveal Fluid Height Based on OCT Measurement

Condition

Central Serous Chorioretinopathy

Intervention

25mg Eplerenone

Study Arms / Comparison Groups

 25mg Eplerenone- Chronic CSCR Diagnosis

Description:  Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

108

Start Date

October 2013

Completion Date

May 2015

Primary Completion Date

March 2015

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

               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 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mitchell Fineman, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01990677

Organization ID

ECSelsior

Secondary IDs

ESCelsior2013

Responsible Party

Principal Investigator

Study Sponsor

Wills Eye

Collaborators

 Mid Atlantic Retina

Study Sponsor

Mitchell Fineman, MD, Principal Investigator, Mid Atlantic Retina

Verification Date

October 2018