Central Serous Chorioretinopathy
Conditions
Keywords
Central Serous Chorioretinopathy, csr, cscr, eplerenone, vision, choroid, retina, acute, chronic
Brief summary
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .
Detailed description
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).
Interventions
DRUG25mg 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
DRUGPlacebo
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.
Sponsors
Mid Atlantic Retina
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1. Acute- first episode or symptoms less than one month prior to presentation 2. Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or \<50% reduction in fluid thickness on OCT after 3 months.
Exclusion criteria
* Age under 18 * Impaired decision-making ability * At initial laboratory screening serum potassium \>5.5 milliequivalent (mEq)/L * At initial laboratory screening serum creatinine \>2 mg/dL in men and \>1.8 mg/dL in women or decreased renal function by creatinine clearance less than 50 mL/min * Absence of sub-foveal fluid * Any patient with prior treatment for CSCR within 3 months of enrollment * Patients taking potassium supplements or potassium-sparing diuretics spironolactone, amiloride, and triamterene and/or potent CYP3A4 (cytochrome) inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, rituximab, tacrolimus, voriconazole nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) * Women who are pregnant or are actively trying to conceive * Patients with type 1 or type 2 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. | Baseline and 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Subfoveal Fluid Height Based on OCT Measurement | Baseline and Month 2 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT | Baseline and Month 2 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 5 |
| Total | 15 |
Baseline characteristics
| Characteristic | Placebo- Chronic CSCR Diagnosis | 25mg Eplerenone- Chronic CSCR Diagnosis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 9 Participants | 13 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 5.5 | 50 years STANDARD_DEVIATION 11.8 | 54 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 5 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 6 |
| other Total, other adverse events | 1 / 12 | 0 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 |
Outcome results
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.
Time frame: Baseline and 2 months
Population: Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 25mg Eplerenone- Chronic CSCR Diagnosis | Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. | Baseline | 139.3 microns | Standard Deviation 58.7 |
| 25mg Eplerenone- Chronic CSCR Diagnosis | Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. | Month 2 | 51.8 microns | Standard Deviation 52.2 |
| Placebo- Chronic CSCR Diagnosis | Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. | Baseline | 135.9 microns | Standard Deviation 21.8 |
| Placebo- Chronic CSCR Diagnosis | Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement. | Month 2 | 172.3 microns | Standard Deviation 88.8 |
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.
Time frame: Baseline and Month 2
Population: Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 25mg Eplerenone- Chronic CSCR Diagnosis | Mean Change in Subfoveal Fluid Height Based on OCT Measurement | Baseline | 121.4 microns | Standard Deviation 75 |
| 25mg Eplerenone- Chronic CSCR Diagnosis | Mean Change in Subfoveal Fluid Height Based on OCT Measurement | Month 2 | 29.4 microns | Standard Deviation 34 |
| Placebo- Chronic CSCR Diagnosis | Mean Change in Subfoveal Fluid Height Based on OCT Measurement | Baseline | 92.1 microns | Standard Deviation 47.4 |
| Placebo- Chronic CSCR Diagnosis | Mean Change in Subfoveal Fluid Height Based on OCT Measurement | Month 2 | 134.0 microns | Standard Deviation 105.9 |
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.
Time frame: Baseline and Month 2
Population: Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| 25mg Eplerenone- Chronic CSCR Diagnosis | Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT | 11 Eyes |
| Placebo- Chronic CSCR Diagnosis | Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT | 1 Eyes |