Trial Outcomes & Findings for Eplerenone for Central Serous Chorioretinopathy (NCT NCT01822561)
NCT ID: NCT01822561
Last Updated: 2018-05-16
Results Overview
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
COMPLETED
PHASE2
17 participants
Baseline and 1 month after treatment
2018-05-16
Participant Flow
Patients with central serous chorioretinopathy were recruited in the ophthalmology clinic at Tufts Medical Center in Boston, MA between April 2013 and April 2017.
Unit of analysis: One eye from each subject was used
Participant milestones
| Measure |
Eplerenone Group
All patients in this study received Eplerenone 50mg once daily for 4 weeks.
Eplerenone 50mg: All patients received the same dose of eplerenone.
|
|---|---|
|
Overall Study
STARTED
|
15 15
|
|
Overall Study
COMPLETED
|
13 13
|
|
Overall Study
NOT COMPLETED
|
2 2
|
Reasons for withdrawal
| Measure |
Eplerenone Group
All patients in this study received Eplerenone 50mg once daily for 4 weeks.
Eplerenone 50mg: All patients received the same dose of eplerenone.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CSCR Patients Who Received Eplerenone
n=13 Participants
All patients were diagnosed with central serous chorioretinopathy. All patients received 50mg oral eplerenone daily for 4 weeks.
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 2.3 • n=13 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=13 Participants
|
|
Patients with chronic CSCR
|
11 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 month after treatmentOptical 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
Outcome measures
| Measure |
Patients That Took Eplerenone
n=13 Participants
Patients received 50mg oral eplerenone daily for 1 month
|
|---|---|
|
Complete Resolution of Subretinal Fluid
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 1 month after treatmentAutomated 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.
Outcome measures
| Measure |
Patients That Took Eplerenone
n=13 Participants
Patients received 50mg oral eplerenone daily for 1 month
|
|---|---|
|
Change in Macular Thickness
|
-26 Microns
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Baseline and 1 month after treatmentVisual 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)
Outcome measures
| Measure |
Patients That Took Eplerenone
n=13 Participants
Patients received 50mg oral eplerenone daily for 1 month
|
|---|---|
|
Change in Best Corrected Visual Acuity
|
-0.03 logMAR
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Baseline and 1 month after treatmentChoroidal 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.
Outcome measures
| Measure |
Patients That Took Eplerenone
n=13 Participants
Patients received 50mg oral eplerenone daily for 1 month
|
|---|---|
|
Change in Subfoveal Choroidal Thickness, Study Eye
|
29.8 microns
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: Baseline and 1 month after treatmentEplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.
Outcome measures
| Measure |
Patients That Took Eplerenone
n=13 Participants
Patients received 50mg oral eplerenone daily for 1 month
|
|---|---|
|
Change in Serum Potassium
|
0.11 mEq/L
Standard Deviation 0.09
|
Adverse Events
Eplerenone Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eplerenone Group
n=15 participants at risk
All patients had central serous chorioretinopathy and were treated with 50mg oral eplerenone once daily
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.7%
1/15 • Number of events 1 • 3 months. Patients were followed for a minimum of 3 months after treatment was initiated.
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 1 • 3 months. Patients were followed for a minimum of 3 months after treatment was initiated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place