Eplerenone for the Treatment of Central Serous Chorioretinopathy

• Sponsor: Wills Eye (Other)
• Overall Status: Completed
• CT.gov ID: NCT01990677
• Collaborator: Mid Atlantic Retina (Other)
• Enrollment: 108
• Locations: 10
• Arms: 4
• Duration (Months): 19
• Patients Per Site: 10.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

Condition or Disease	Intervention/Treatment	Phase
Central Serous Chorioretinopathy	Drug: 25mg Eplerenone; Drug: Placebo	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Eplerenone for the Treatment of Central Serous Chorioretinopathy
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 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; Other Names: Eplerenone Inspra ; Drug: 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.; Other Names: Sugar pill
Placebo Comparator: 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.	Drug: 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.; Other Names: Sugar pill
Active Comparator: 25mg Eplerenone- Acute CSCR Diagnosis 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.	Drug: 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; Other Names: Eplerenone Inspra ; Drug: 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.; Other Names: Sugar pill
Active Comparator: Placebo- Acute 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 28 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.	Drug: 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.; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mid Atlantic Retina	Cherry Hill	New Jersey	United States	08002
2	Mid Atlantic Retina	Marlton	New Jersey	United States	08053
3	Mid Atlantic Retina	Mays Landing	New Jersey	United States	08330
4	Mid Atlantic Retina	Bala-Cynwyd	Pennsylvania	United States	19004
5	Mid Atlantic Retina	Bethlehem	Pennsylvania	United States	18020
6	Mid Atlantic Retina	Huntingdon Valley	Pennsylvania	United States	19006
7	Mid Atlantic Retina	Lansdale	Pennsylvania	United States	19446
8	Mid Atlantic Retina	New Wilmington	Pennsylvania	United States	19803
9	Mid Atlantic Retina	Newtown Square	Pennsylvania	United States	19073
10	Mid Atlantic Retina	Plymouth Meeting	Pennsylvania	United States	19462

Sponsors and Collaborators

• Wills Eye
• Mid Atlantic Retina

Investigators

• Principal Investigator: Mitchell Fineman, MD, Mid Atlantic Retina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MidAtlantic Retina, Dr. Mitchell Fineman, Wills Eye
• ClinicalTrials.gov Identifier: NCT01990677
• Other Study ID Numbers: ECSelsior; ESCelsior2013
• First Posted: Nov 21, 2013
• Last Update Posted: Nov 7, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by MidAtlantic Retina, Dr. Mitchell Fineman, Wills Eye: Central Serous Chorioretinopathy; csr; cscr; eplerenone; vision; choroid; retina; acute; chronic
• Additional relevant MeSH terms: Central Serous Chorioretinopathy; Eplerenone

Study Results

Participant Flow

Pre-assignment Detail	Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.

Arm/Group Title	25mg Eplerenone- Chronic CSCR Diagnosis	Placebo- Chronic CSCR Diagnosis
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	12	6
COMPLETED	10	5
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	25mg Eplerenone- Chronic CSCR Diagnosis	Placebo- Chronic CSCR Diagnosis	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	10	5	15
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 90%	4 80%	13 86.7%
>=65 years	1 10%	1 20%	2 13.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (11.8)	62 (5.5)	54 (9.7)
Sex: Female, Male (Count of Participants)
Female	2 20%	1 20%	3 20%
Male	8 80%	4 80%	12 80%
Region of Enrollment (Count of Participants)
United States	10 100%	5 100%	15 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
Description	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

Outcome Measure Data

Analysis Population Description

Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.

Arm/Group Title	25mg Eplerenone- Chronic CSCR Diagnosis	Placebo- Chronic CSCR Diagnosis
Arm/Group Description	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.	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.
Measure Participants	10	5
Measure Eyes	15	6
Baseline	139.3 (58.7)	135.9 (21.8)
Month 2	51.8 (52.2)	172.3 (88.8)

2. Secondary Outcome

Title	Mean Change in Subfoveal Fluid Height Based on OCT Measurement
Description	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

Outcome Measure Data

Analysis Population Description

Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.

Arm/Group Title	25mg Eplerenone- Chronic CSCR Diagnosis	Placebo- Chronic CSCR Diagnosis
Arm/Group Description	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.	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.
Measure Participants	10	5
Measure Eyes	15	6
Baseline	121.4 (75.0)	92.1 (47.4)
Month 2	29.4 (34.0)	134.0 (105.9)

3. Other Pre-specified Outcome

Title	Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT
Description	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

Outcome Measure Data

Analysis Population Description

Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.

Arm/Group Title	25mg Eplerenone- Chronic CSCR Diagnosis	Placebo- Chronic CSCR Diagnosis
Arm/Group Description	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.	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.
Measure Participants	10	5
Measure Eyes	15	6
Count of Units [Eyes]	11	1

Adverse Events

Adverse Event Reporting Description	Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
Arm/Group Title	25mg Eplerenone- Chronic CSCR Diagnosis		Placebo- Chronic CSCR Diagnosis
Arm/Group Description	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.		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.
All Cause Mortality
	25mg Eplerenone- Chronic CSCR Diagnosis		Placebo- Chronic CSCR Diagnosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/6 (0%)
Serious Adverse Events
	25mg Eplerenone- Chronic CSCR Diagnosis		Placebo- Chronic CSCR Diagnosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	25mg Eplerenone- Chronic CSCR Diagnosis		Placebo- Chronic CSCR Diagnosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/6 (0%)
General disorders
Dizziness	1/12 (8.3%)	1	0/6 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.