Eplerenone for the Treatment of Central Serous Chorioretinopathy

October 8, 2018 updated by: MidAtlantic Retina, Wills Eye
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Mid Atlantic Retina
      • Marlton, New Jersey, United States, 08053
        • Mid Atlantic Retina
      • Mays Landing, New Jersey, United States, 08330
        • Mid Atlantic Retina
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Mid Atlantic Retina
      • Bethlehem, Pennsylvania, United States, 18020
        • Mid Atlantic Retina
      • Huntingdon Valley, Pennsylvania, United States, 19006
        • Mid Atlantic Retina
      • Lansdale, Pennsylvania, United States, 19446
        • Mid Atlantic Retina
      • New Wilmington, Pennsylvania, United States, 19803
        • Mid Atlantic Retina
      • Newtown Square, Pennsylvania, United States, 19073
        • Mid Atlantic Retina
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Mid Atlantic Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 25mg Eplerenone- Chronic CSCR Diagnosis
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.
Drug: 25mg Eplerenone
Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Other Names:
  • Eplerenone
  • Inspra
Drug: Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
Other Names:
  • Sugar pill
Placebo Comparator: Placebo- Chronic CSCR Diagnosis
Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Drug: Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
Other Names:
  • Sugar pill
Active Comparator: 25mg Eplerenone- Acute CSCR Diagnosis
Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. 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.
Drug: 25mg Eplerenone
Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
Other Names:
  • Eplerenone
  • Inspra
Drug: Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
Other Names:
  • Sugar pill
Active Comparator: Placebo- Acute CSCR Diagnosis.
Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 28 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Drug: Placebo
Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
Time Frame: Baseline and 2 months
Mean change in maximal subretinal fluid height based on spectral domain OCT from baseline to month 2 in chronic central serous chorioretinopathy (CSCR) patients receiving placebo versus eplerenone.
Baseline and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Subfoveal Fluid Height Based on OCT Measurement
Time Frame: Baseline and Month 2
Mean change in subfoveal fluid height based on spectral domain OCT measurement from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.
Baseline and Month 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT
Time Frame: Baseline and Month 2
Proportion of eyes having a decrease in subretinal fluid on spectral domain OCT from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.
Baseline and Month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Collaborators

Mid Atlantic Retina

Investigators

  • Principal Investigator: Mitchell Fineman, MD, Mid Atlantic Retina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECSelsior
  • ESCelsior2013 (Other Identifier: Mid Atlantic Retina)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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