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Trial record 6 of 112 for:    EPLERENONE

Eplerenone for the Treatment of Central Serous Chorioretinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01990677
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : June 29, 2017
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Mid Atlantic Retina
Information provided by (Responsible Party):
MidAtlantic Retina, Wills Eye

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Central Serous Chorioretinopathy
Interventions Drug: 25mg Eplerenone
Drug: Placebo
Enrollment 108
Recruitment Details  
Pre-assignment Details Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
Arm/Group Title 25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis
Hide Arm/Group 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.

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

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.

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.

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.

Period Title: Overall Study
Started 12 6
Completed 10 5
Not Completed 2 1
Arm/Group Title 25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis Total
Hide Arm/Group 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.

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

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 10 5 15
Hide Baseline Analysis Population Description
Two individuals in the treatment group and one in the placebo group were lost to follow-up.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 5 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  90.0%
4
  80.0%
13
  86.7%
>=65 years
1
  10.0%
1
  20.0%
2
  13.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 5 participants 15 participants
50  (11.8) 62  (5.5) 54  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 5 participants 15 participants
Female
2
  20.0%
1
  20.0%
3
  20.0%
Male
8
  80.0%
4
  80.0%
12
  80.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 5 participants 15 participants
10
 100.0%
5
 100.0%
15
 100.0%
1.Primary Outcome
Title Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
Arm/Group Title 25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis
Hide Arm/Group 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.

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

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.

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.

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.

Overall Number of Participants Analyzed 10 5
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
15 6
Mean (Standard Deviation)
Unit of Measure: microns
Baseline 139.3  (58.7) 135.9  (21.8)
Month 2 51.8  (52.2) 172.3  (88.8)
2.Secondary Outcome
Title Mean Change in Subfoveal Fluid Height Based on OCT Measurement
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
Arm/Group Title 25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis
Hide Arm/Group 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.

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

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.

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.

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.

Overall Number of Participants Analyzed 10 5
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
15 6
Mean (Standard Deviation)
Unit of Measure: microns
Baseline 121.4  (75.0) 92.1  (47.4)
Month 2 29.4  (34.0) 134.0  (105.9)
3.Other Pre-specified Outcome
Title Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
Arm/Group Title 25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis
Hide Arm/Group 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.

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

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.

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.

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.

Overall Number of Participants Analyzed 10 5
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
15 6
Count of Units
Unit of Measure: Eyes
11
  73.3%
1
  16.7%
Time Frame [Not Specified]
Adverse Event Reporting Description Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
 
Arm/Group Title 25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis
Hide Arm/Group 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.

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

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.

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.

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.

All-Cause Mortality
25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
25mg Eplerenone- Chronic CSCR Diagnosis Placebo- Chronic CSCR Diagnosis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/6 (0.00%)    
General disorders     
Dizziness   1/12 (8.33%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mitchell Fineman,MD
Organization: Wills Eye
Phone: 215-928-3092
EMail: research@midatlanticretina.com
Layout table for additonal information
Responsible Party: MidAtlantic Retina, Wills Eye
ClinicalTrials.gov Identifier: NCT01990677     History of Changes
Other Study ID Numbers: ECSelsior
ESCelsior2013 ( Other Identifier: Mid Atlantic Retina )
First Submitted: November 15, 2013
First Posted: November 21, 2013
Results First Submitted: April 12, 2017
Results First Posted: June 29, 2017
Last Update Posted: November 7, 2018