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Eplerenone for Central Serous Chorioretinopathy

Information source: Tufts Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Central Serous Chorioretinopathy

Intervention: Eplerenone 50mg (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Tufts Medical Center


- The goal of the study is to examine the short-term effects and safety of a systemic

anti-aldosterone medication, eplerenone, in a small group of patients with central serous chorioretinopathy (CSCR).

- There is currently no standard treatment or therapy for either acute or chronic CSCR, a

potentially debilitating eye disease.

- There is evidence in both animals and humans that high blood serum corticosteroid

levels can cause or worsen CSCR or findings similar to CSCR in the choroid and retina

- Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and

anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR

- The investigators' aim is to evaluate a standardized dose of eplerenone in a controlled

prospective fashion for both acute and chronic CSCR.

- The study consists of taking a standard dose of eplerenone, 50mg once daily, for 1


- Over the course of the month, patients will be monitored for side effects, as well as

visual and anatomical response to the medication

Clinical Details

Official title: Eplerenone for Central Serous Chorioretinopathy: A Pilot Study

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Resolution of Sub-retinal Fluid

Secondary outcome:

Change in macular thickness

Best Corrected Visual Acuity

Change in choroidal thickness, both eyes

Safety and Tolerability Characteristics

Detailed description:

- The investigators hypothesize that aldosterone inhibition with eplerenone will decrease

choroidal vessel vasodilation, focal leakage, and choroidal thickness in patients with both acute and chronic CSCR, leading to resolution of subretinal fluid and ultimately an improvement in symptoms.

- Resolution of sub-retinal fluid will be the primary outcome, which can be precisely

measured using optical coherence tomography (OCT)

- Secondary outcomes will include: Change in macular thickness measured with OCT, in

central macular circle thickness on OCT, change in visual acuity, change in dye leakage characteristics on fluorescein angiography, change in OCT characteristics of the fellow eye, and safety and tolerability characteristics

- In acute CSCR, subretinal fluid often resolves on its own, but it often takes several

months (the literature shows that ~20% of patients have complete resolution of sub-retinal fluid on OCT 1 month after presentation)

- Chronic CSCR is defined as persistent fluid on OCT after 3 months of symptom onset, or

recurrence of signs and symptoms within 1 year after the prior episode

- In this study, the investigators will not make a distinction between acute and chronic


- Eplerenone, a generic medication, is a potassium sparing diuretic, which is FDA

approved to treat heart failure as well as high blood pressure, but is not FDA approved for treatment of central serous chorioretinopathy.

- The most important side effect of eplerenone is elevation of serum potassium and

decrease of blood pressure

- Patients will therefore be screened with routine blood tests as suggested by the

package insert of the medication, and serum potassium and blood pressure will be monitored routinely as directed by the medication package insert

- Study visits will be performed at therapy initiation, 1 week, 2 weeks, and 4 weeks


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. Age 18 or over 2. Ability to give written informed consent 3. Presence of sub-retinal fluid under the fovea as seen on OCT 4. Diagnosis of Acute or Chronic CSCR:

- Acute CSCR: First presentation to eye clinic with visual symptoms, including

decreased vision or visual distortion, and the characteristic appearance of CSCR on examination, fluorescein angiography, and OCT.

- Chronic CSCR: Previous diagnosis of CSCR, persistent subretinal fluid on OCT for

more than 3 months after initial presentation to the eye clinic, and <50% reduction in fluid thickness on OCT after 3 months. Patients who have had previous treatment for CSCR may be included. Exclusion Criteria: 1. Age less than 18 2. Persons with impaired decision-making ability. 3. Women who are known to be pregnant or are actively trying to conceive. 4. Additional eye disease affecting the macula or posterior retina. 5. At screening, serum potassium concentration ≥5. 0 mEq/L , a serum creatinine concentration >2 mg/dL in men and >1. 8 mg/dL in women, or a creatinine clearance <50 mL/min, and during concomitant administration of potassium supplements, potassium-sparing diuretics, and/or potent CYP3A4 inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, Rituximab, tacrolimus or voriconazole). 6. Patients with type 2 diabetes will be screened for microalbuminuria with a urinalysis. If microalbuminuria is present, these patients will be excluded.

Locations and Contacts

New England Eye Center / Tufts Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Andre J Witkin, MD, Phone: 617-646-7950, Email: awitkin@tuftsmedicalcenter.org
Julie Burt, Phone: 617-636-0747, Email: jburt@tuftsmedicalcenter.org
Andre J Witkin, MD, Principal Investigator
Jay S Duker, MD, Sub-Investigator
Elias Reichel, MD, Sub-Investigator
Caroline R Baumal, MD, Sub-Investigator
Adam R Rogers, MD, Sub-Investigator
Nadia K Waheed, MD, Sub-Investigator
Roger Goldberg, MD, Sub-Investigator
Marissa Weber, MD, Sub-Investigator
Jordana Fein, MD, Sub-Investigator
Additional Information

Related 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.

Starting date: May 2013
Last updated: December 3, 2014

Page last updated: August 23, 2015

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