Eplerenone for Central Serous Chorioretinopathy

• ClinicalTrials.gov Identifier: NCT01822561
• Recruitment Status: Completed
• First Posted: April 2, 2013
• Results First Posted: May 16, 2018
• Last Update Posted: May 16, 2018
• Sponsor: Tufts Medical Center
• Information provided by (Responsible Party): Tufts Medical Center

• Study Type: Interventional
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Central Serous Chorioretinopathy
• Intervention: Drug: Eplerenone 50mg
• Enrollment: 17

Participant Flow

Recruitment Details	Patients with central serous chorioretinopathy were recruited in the ophthalmology clinic at Tufts Medical Center in Boston, MA between April 2013 and April 2017.
Pre-assignment Details

Arm/Group Title	Eplerenone Group
Arm/Group Description	All patients in this study received Eplerenone 50mg once daily for 4 weeks. Eplerenone 50mg: All patients received the same dose of eplerenone.
Period Title: Overall Study
	Number of participants	Number of units (One eye from each subject was used)
Started	15	15
Completed	13	13
Not Completed	2	2
Reason Not Completed
Withdrawal by Subject	2

Baseline Characteristics

Arm/Group Title		CSCR Patients Who Received Eplerenone
Arm/Group Description		All patients were diagnosed with central serous chorioretinopathy. All patients received 50mg oral eplerenone daily for 4 weeks.
Overall Number of Baseline Participants		13
Baseline Analysis Population Description		2 Acute CSCR, 11 Chronic CSCR
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	13 participants
		55.6 (2.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants
	Female	0 0.0%
	Male	13 100.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	13 participants
		13 100.0%
Patients with chronic CSCR; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants
		11 84.6%

Outcome Measures

1. Primary Outcome

Title	Complete Resolution of Subretinal Fluid
Description	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
Time Frame	Baseline and 1 month after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients That Took Eplerenone
Arm/Group Description:	Patients received 50mg oral eplerenone daily for 1 month
Overall Number of Participants Analyzed	13
Measure Type: Number; Unit of Measure: participants
	0

2. Secondary Outcome

Title	Change in Macular Thickness
Description	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.
Time Frame	Baseline and 1 month after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients That Received Eplerenone
Arm/Group Description:	Patients took 50mg oral eplerenone daily for 1 month
Overall Number of Participants Analyzed	13
Mean (Standard Deviation); Unit of Measure: Microns
	-26 (27)

3. Secondary Outcome

Title	Change in Best Corrected Visual Acuity
Description	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)
Time Frame	Baseline and 1 month after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients That Took Eplerenone
Arm/Group Description:	Patients received oral Eplerenone 50mg once daily for 4 weeks.
Overall Number of Participants Analyzed	13
Mean (Standard Deviation); Unit of Measure: logMAR
	-0.03 (0.08)

4. Secondary Outcome

Title	Change in Subfoveal Choroidal Thickness, Study Eye
Description	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.
Time Frame	Baseline and 1 month after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients That Received Eplerenone
Arm/Group Description:	Patients received oral Eplerenone 50mg once daily for 4 weeks.
Overall Number of Participants Analyzed	13
Mean (Standard Deviation); Unit of Measure: microns
	29.8 (18.5)

5. Secondary Outcome

Title	Change in Serum Potassium
Description	Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.
Time Frame	Baseline and 1 month after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients That Received Eplerenone
Arm/Group Description:	Patients took oral Eplerenone 50mg once daily for 4 weeks.
Overall Number of Participants Analyzed	13
Mean (Standard Deviation); Unit of Measure: mEq/L
	0.11 (0.09)

Adverse Events

Time Frame	3 months. Patients were followed for a minimum of 3 months after treatment was initiated.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Eplerenone Group
Arm/Group Description	All patients had central serous chorioretinopathy and were treated with 50mg oral eplerenone once daily
All-Cause Mortality
	Eplerenone Group
	Affected / at Risk (%)
Total	0/15 (0.00%)
Serious Adverse Events
	Eplerenone Group
	Affected / at Risk (%)	# Events
Total	0/15 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Eplerenone Group
	Affected / at Risk (%)	# Events
Total	2/15 (13.33%)
Cardiac disorders
Palpitations † [1]	1/15 (6.67%)	1
Respiratory, thoracic and mediastinal disorders
Shortness of breath † [2]	1/15 (6.67%)	1
† Indicates events were collected by systematic assessment; [1] One patient stopped treatment after experiencing subjective headache and heart palpitations after a single dose. Symptoms resolved within 1 day of stopping the medication.; [2] One patient stopped treatment after 2 weeks because of subjective shortness of breath. Symptoms resolved within 1 day of stopping the medication.

Limitations and Caveats

The study had limited enrollment due to lack of interest on the part of potential study subjects.

More Information

Certain Agreements

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

Results Point of Contact

• Name/Title: Andre Witkin
• Organization: Tufts Medical Center
• Phone: 6176367950
• EMail: awitkin@tuftsmedicalcenter.org

Publications of Results:

Fujimoto H, Gomi F, Wakabayashi T, Sawa M, Tsujikawa M, Tano Y. Morphologic changes in acute central serous chorioretinopathy evaluated by fourier-domain optical coherence tomography. Ophthalmology. 2008 Sep;115(9):1494-500, 1500.e1-2. doi: 10.1016/j.ophtha.2008.01.021. Epub 2008 Apr 18.

Other Publications:

Zhao M, Célérier I, Bousquet E, Jeanny JC, Jonet L, Savoldelli M, Offret O, Curan A, Farman N, Jaisser F, Behar-Cohen F. Mineralocorticoid receptor is involved in rat and human ocular chorioretinopathy. J Clin Invest. 2012 Jul;122(7):2672-9. doi: 10.1172/JCI61427. Epub 2012 Jun 11.

Gemenetzi M, De Salvo G, Lotery AJ. Central serous chorioretinopathy: an update on pathogenesis and treatment. Eye (Lond). 2010 Dec;24(12):1743-56. doi: 10.1038/eye.2010.130. Epub 2010 Oct 8. Review.

Bouzas EA, Karadimas P, Pournaras CJ. Central serous chorioretinopathy and glucocorticoids. Surv Ophthalmol. 2002 Sep-Oct;47(5):431-48. Review.

Chan WM, Lai TY, Lai RY, Liu DT, Lam DS. Half-dose verteporfin photodynamic therapy for acute central serous chorioretinopathy: one-year results of a randomized controlled trial. Ophthalmology. 2008 Oct;115(10):1756-65. doi: 10.1016/j.ophtha.2008.04.014. Epub 2008 Jun 5.

Imamura Y, Fujiwara T, Margolis R, Spaide RF. Enhanced depth imaging optical coherence tomography of the choroid in central serous chorioretinopathy. Retina. 2009 Nov-Dec;29(10):1469-73. doi: 10.1097/IAE.0b013e3181be0a83.

Reibaldi M, Cardascia N, Longo A, Furino C, Avitabile T, Faro S, Sanfilippo M, Russo A, Uva MG, Munno F, Cannemi V, Zagari M, Boscia F. Standard-fluence versus low-fluence photodynamic therapy in chronic central serous chorioretinopathy: a nonrandomized clinical trial. Am J Ophthalmol. 2010 Feb;149(2):307-315.e2. doi: 10.1016/j.ajo.2009.08.026. Epub 2009 Nov 6.

Robertson DM, Ilstrup D. Direct, indirect, and sham laser photocoagulation in the management of central serous chorioretinopathy. Am J Ophthalmol. 1983 Apr;95(4):457-66.

Nielsen JS, Jampol LM. Oral mifepristone for chronic central serous chorioretinopathy. Retina. 2011 Oct;31(9):1928-36. doi: 10.1097/IAE.0b013e31821c3ef6.

Forooghian F, Meleth AD, Cukras C, Chew EY, Wong WT, Meyerle CB. Finasteride for chronic central serous chorioretinopathy. Retina. 2011 Apr;31(4):766-71. doi: 10.1097/IAE.0b013e3181f04a35.

Weinberger MH, Roniker B, Krause SL, Weiss RJ. Eplerenone, a selective aldosterone blocker, in mild-to-moderate hypertension. Am J Hypertens. 2002 Aug;15(8):709-16.

Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003 Apr 3;348(14):1309-21. Epub 2003 Mar 31. Erratum in: N Engl J Med. 2003 May 29;348(22):2271.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moein HR, Bierman LW, Novais EA, Moreira-Neto C, Baumal CR, Rogers A, Duker JS, Witkin AJ. Short-term eplerenone for treatment of chronic central serous chorioretinopathy; a prospective study. Int J Retina Vitreous. 2019 Sep 9;5:39. doi: 10.1186/s40942-019-0190-y. eCollection 2019.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT01822561 History of Changes
• Other Study ID Numbers: NEEC-10722
• First Submitted: March 25, 2013
• First Posted: April 2, 2013
• Results First Submitted: April 17, 2018
• Results First Posted: May 16, 2018
• Last Update Posted: May 16, 2018