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Trial record 4 of 112 for:    EPLERENONE

Eplerenone for Central Serous Chorioretinopathy

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ClinicalTrials.gov Identifier: NCT01822561
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Central Serous Chorioretinopathy
Intervention Drug: Eplerenone 50mg
Enrollment 17
Recruitment Details Patients with central serous chorioretinopathy were recruited in the ophthalmology clinic at Tufts Medical Center in Boston, MA between April 2013 and April 2017.
Pre-assignment Details  
Arm/Group Title Eplerenone Group
Hide Arm/Group Description

All patients in this study received Eplerenone 50mg once daily for 4 weeks.

Eplerenone 50mg: All patients received the same dose of eplerenone.

Period Title: Overall Study
Number of participants Number of units (One eye from each subject was used)
Started 15 15
Completed 13 13
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             2            
Arm/Group Title CSCR Patients Who Received Eplerenone
Hide Arm/Group Description All patients were diagnosed with central serous chorioretinopathy. All patients received 50mg oral eplerenone daily for 4 weeks.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
2 Acute CSCR, 11 Chronic CSCR
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
55.6  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
0
   0.0%
Male
13
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
Patients with chronic CSCR  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
11
  84.6%
1.Primary Outcome
Title Complete Resolution of Subretinal Fluid
Hide Description Optical coherence tomography is an imaging technique capable of extremely high resolution (~5-7 microns) imaging of the macula, and is able to detect the presence and amount of subretinal fluid present, the key anatomic abnormality in Central Serous Chorioretinopathy
Time Frame Baseline and 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients That Took Eplerenone
Hide Arm/Group Description:
Patients received 50mg oral eplerenone daily for 1 month
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Change in Macular Thickness
Hide Description Automated software to calculate the thickness of the macula is standard on commercial OCT devices. Macular thickness before and after treatment will be assessed and compared.
Time Frame Baseline and 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients That Received Eplerenone
Hide Arm/Group Description:
Patients took 50mg oral eplerenone daily for 1 month
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Microns
-26  (27)
3.Secondary Outcome
Title Change in Best Corrected Visual Acuity
Hide Description Visual acuity will be measured with standard eye charts, with manifest refraction at the initiation and conclusion of treatment. Although an important measure, this was not chosen as the primary outcome measure, as some patients with central serous chorioretinopathy may have a normal visual acuity when properly refracted (refraction can change with elevation of the macula by sub-retinal fluid)
Time Frame Baseline and 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients That Took Eplerenone
Hide Arm/Group Description:
Patients received oral Eplerenone 50mg once daily for 4 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: logMAR
-0.03  (0.08)
4.Secondary Outcome
Title Change in Subfoveal Choroidal Thickness, Study Eye
Hide Description Choroidal thickness can be measured using optical coherence tomography, and is known to be affected in patients with central serous chorioretinopathy. Thickness of the choroid under the fovea will be manually calculated in both the study eye.
Time Frame Baseline and 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients That Received Eplerenone
Hide Arm/Group Description:
Patients received oral Eplerenone 50mg once daily for 4 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: microns
29.8  (18.5)
5.Secondary Outcome
Title Change in Serum Potassium
Hide Description Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.
Time Frame Baseline and 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients That Received Eplerenone
Hide Arm/Group Description:
Patients took oral Eplerenone 50mg once daily for 4 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mEq/L
0.11  (0.09)
Time Frame 3 months. Patients were followed for a minimum of 3 months after treatment was initiated.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eplerenone Group
Hide Arm/Group Description All patients had central serous chorioretinopathy and were treated with 50mg oral eplerenone once daily
All-Cause Mortality
Eplerenone Group
Affected / at Risk (%)
Total   0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone Group
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eplerenone Group
Affected / at Risk (%) # Events
Total   2/15 (13.33%)    
Cardiac disorders   
Palpitations  [1]  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Shortness of breath  [2]  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
One patient stopped treatment after experiencing subjective headache and heart palpitations after a single dose. Symptoms resolved within 1 day of stopping the medication.
[2]
One patient stopped treatment after 2 weeks because of subjective shortness of breath. Symptoms resolved within 1 day of stopping the medication.
The study had limited enrollment due to lack of interest on the part of potential study subjects.
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: Andre Witkin
Organization: Tufts Medical Center
Phone: 6176367950
EMail: awitkin@tuftsmedicalcenter.org
Other Publications:
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01822561     History of Changes
Other Study ID Numbers: NEEC-10722
First Submitted: March 25, 2013
First Posted: April 2, 2013
Results First Submitted: April 17, 2018
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018