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Eplerenone for the Treatment of Central Serous Chorioretinopathy

Primary Purpose

Central Serous Chorioretinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
25mg Eplerenone
Placebo
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring Central Serous Chorioretinopathy, csr, cscr, eplerenone, vision, choroid, retina, acute, chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mid Atlantic Retina
  • Mid Atlantic Retina
  • Mid Atlantic Retina
  • Mid Atlantic Retina
  • Mid Atlantic Retina
  • Mid Atlantic Retina
  • Mid Atlantic Retina
  • Mid Atlantic Retina
  • Mid Atlantic Retina
  • Mid Atlantic Retina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

25mg Eplerenone- Chronic CSCR Diagnosis

Placebo- Chronic CSCR Diagnosis

25mg Eplerenone- Acute CSCR Diagnosis

Placebo- Acute CSCR Diagnosis.

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Change in Subfoveal Fluid Height Based on OCT Measurement
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.

Full Information

First Posted
November 15, 2013
Last Updated
October 8, 2018
Sponsor
Wills Eye
Collaborators
Mid Atlantic Retina
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1. Study Identification

Unique Protocol Identification Number
NCT01990677
Brief Title
Eplerenone for the Treatment of Central Serous Chorioretinopathy
Official Title
Eplerenone for the Treatment of Central Serous Chorioretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Mid Atlantic Retina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
Central Serous Chorioretinopathy, csr, cscr, eplerenone, vision, choroid, retina, acute, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25mg Eplerenone- Chronic CSCR Diagnosis
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo- Chronic CSCR Diagnosis
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
25mg Eplerenone- Acute CSCR Diagnosis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo- Acute CSCR Diagnosis.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
25mg Eplerenone
Other Intervention Name(s)
Eplerenone, Inspra
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
Description
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.
Time Frame
Baseline and 2 months
Secondary Outcome Measure Information:
Title
Mean Change in Subfoveal Fluid Height Based on OCT Measurement
Description
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.
Time Frame
Baseline and Month 2
Other Pre-specified Outcome Measures:
Title
Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT
Description
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.
Time Frame
Baseline and Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 <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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Fineman, MD
Organizational Affiliation
Mid Atlantic Retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid Atlantic Retina
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Mid Atlantic Retina
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Mid Atlantic Retina
City
Mays Landing
State/Province
New Jersey
ZIP/Postal Code
08330
Country
United States
Facility Name
Mid Atlantic Retina
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Mid Atlantic Retina
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
Country
United States
Facility Name
Mid Atlantic Retina
City
Huntingdon Valley
State/Province
Pennsylvania
ZIP/Postal Code
19006
Country
United States
Facility Name
Mid Atlantic Retina
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Mid Atlantic Retina
City
New Wilmington
State/Province
Pennsylvania
ZIP/Postal Code
19803
Country
United States
Facility Name
Mid Atlantic Retina
City
Newtown Square
State/Province
Pennsylvania
ZIP/Postal Code
19073
Country
United States
Facility Name
Mid Atlantic Retina
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Eplerenone for the Treatment of Central Serous Chorioretinopathy

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