Trial · NCT01822561
Eplerenone for Central Serous Chorioretinopathy
NCT01822561, Phase 2, Completed, Tufts Medical Center; results first posted 2018-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Eplerenone for Central Serous Chorioretinopathy. Trials, record NCT01822561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01822561
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eplerenone for Central Serous Chorioretinopathy
- NCT number
- NCT01822561
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Central Serous Chorioretinopathy
- Interventions
- Eplerenone 50mg
- First posted
- 2013-04-02
- Last updated
- 2018-05-16
- Results first posted
- 2018-05-16
- Limitations and caveats
- The study had limited enrollment due to lack of interest on the part of potential study subjects.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Resolution of Subretinal Fluid | Baseline and 1 month after treatment | 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 |
| Secondary | Change in Macular Thickness | Baseline and 1 month after treatment | 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. |
| Secondary | Change in Best Corrected Visual Acuity | Baseline and 1 month after treatment | 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) |
| Secondary | Change in Subfoveal Choroidal Thickness, Study Eye | Baseline and 1 month after treatment | 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. |
| Secondary | Change in Serum Potassium | Baseline and 1 month after treatment | Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Resolution of Subretinal Fluid | Baseline and 1 month after treatment | participants | NUMBER | |
| SECONDARY | Change in Macular Thickness | Baseline and 1 month after treatment | Microns | MEAN | |
| SECONDARY | Change in Best Corrected Visual Acuity | Baseline and 1 month after treatment | logMAR | MEAN | |
| SECONDARY | Change in Subfoveal Choroidal Thickness, Study Eye | Baseline and 1 month after treatment | microns | MEAN | |
| SECONDARY | Change in Serum Potassium | Baseline and 1 month after treatment | mEq/L | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Resolution of Subretinal Fluid | Patients That Took Eplerenone | 0 | participants | ||
| Change in Macular Thickness | Patients That Received Eplerenone | -26 | Standard Deviation 27 | Microns | |
| Change in Best Corrected Visual Acuity | Patients That Took Eplerenone | -0.03 | Standard Deviation 0.08 | logMAR | |
| Change in Subfoveal Choroidal Thickness, Study Eye | Patients That Received Eplerenone | 29.8 | Standard Deviation 18.5 | microns | |
| Change in Serum Potassium | Patients That Received Eplerenone | 0.11 | Standard Deviation 0.09 | mEq/L |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eplerenone Group | 15 | 15 |
| Overall Study | COMPLETED | Eplerenone Group | 13 | 13 |
| Overall Study | NOT COMPLETED | Eplerenone Group | 2 | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Shortness of breath | Respiratory, thoracic and mediastinal disorders | Eplerenone Group | 1 | 15 | 1 |
| other | Palpitations | Cardiac disorders | Eplerenone Group | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eplerenone Group | 0 | 15 |
| Total, other adverse events | Eplerenone Group | 2 | 15 |
| Total, serious adverse events | Eplerenone Group | 0 | 15 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01822561
GET https://conductscience.org/api/trials/v1/NCT01822561/registered