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| ID | Type | Description | Link |
|---|---|---|---|
| ESCelsior2013 | Other Identifier | Mid Atlantic Retina |
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| Name | Class |
|---|---|
| Mid Atlantic Retina | OTHER |
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To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25mg Eplerenone- Chronic CSCR Diagnosis | Active Comparator | 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. |
|
| Placebo- Chronic CSCR Diagnosis | Placebo Comparator | 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. |
|
| 25mg Eplerenone- Acute CSCR Diagnosis | Active Comparator | 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. |
|
| Placebo- Acute CSCR Diagnosis. | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25mg Eplerenone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT | 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. | Baseline and Month 2 |
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Fineman, MD | Mid Atlantic Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid Atlantic Retina | Cherry Hill | New Jersey | 08002 | United States | ||
| Mid Atlantic Retina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40522203 | Derived | Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3. |
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Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 25mg Eplerenone- Chronic CSCR Diagnosis | 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. |
| FG001 | Placebo- Chronic CSCR Diagnosis | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two individuals in the treatment group and one in the placebo group were lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | 25mg Eplerenone- Chronic CSCR Diagnosis | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data. | Posted | Mean | Standard Deviation | microns | Baseline and 2 months | Eyes | Eyes |
|
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Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 25mg Eplerenone- Chronic CSCR Diagnosis | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Fineman,MD | Wills Eye | 215-928-3092 | research@midatlanticretina.com |
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| ID | Term |
|---|---|
| D056833 | Central Serous Chorioretinopathy |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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|
|
|
| Placebo | Drug | 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. |
|
|
| Marlton |
| New Jersey |
| 08053 |
| United States |
| Mid Atlantic Retina | Mays Landing | New Jersey | 08330 | United States |
| Mid Atlantic Retina | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Mid Atlantic Retina | Bethlehem | Pennsylvania | 18020 | United States |
| Mid Atlantic Retina | Huntingdon Valley | Pennsylvania | 19006 | United States |
| Mid Atlantic Retina | Lansdale | Pennsylvania | 19446 | United States |
| Mid Atlantic Retina | New Wilmington | Pennsylvania | 19803 | United States |
| Mid Atlantic Retina | Newtown Square | Pennsylvania | 19073 | United States |
| Mid Atlantic Retina | Plymouth Meeting | Pennsylvania | 19462 | United States |
| BG001 | Placebo- Chronic CSCR Diagnosis | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo- Chronic CSCR Diagnosis | 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. |
|
|
| Secondary | 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. | Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data. | Posted | Mean | Standard Deviation | microns | Baseline and Month 2 | Eyes | Eyes |
|
|
|
| Other Pre-specified | Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT | 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. | Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data. | Posted | Count of Units | Eyes | Baseline and Month 2 | Eyes | Eyes |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Placebo- Chronic CSCR Diagnosis | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D001988 |
| Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |