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A Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy

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ClinicalTrials.gov Identifier: NCT02215330
Recruitment Status : Unknown
Verified August 2014 by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery.
Recruitment status was:  Not yet recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Brief Summary:

Central serous chorioretinopathy (CSC) is supposedly the fourth most common non-surgical retinopathy after age-related macular degeneration, diabetic retinopathy and branch retinal vein occlusion. The disease was first described by Albrecht von Graefe in 1866 as a 'recurrent central retinitis' and is nowadays commonly known as 'central serous chorioretinopathy', a term mainly coined by Donald Gass in the late 1960s.

Although the disease has been known for decades, the underlying mechanism is not yet fully understood. Numerous studies have shown an involvement of the retinal pigment epithelium (RPE) and the choroid which lead to accumulation of subretinal fluid with subsequent detachment of the neurosensory retina.

Among several assumed risk factors, high serum glucocorticoid levels seem to be related to the occurrence of CSC.

CSC typically affects young, male patients unilaterally and causes decreased and distorted vision, often associated with metamorphopsia, micropsia, dyschromatopsia and reduced contrast sensitivity. CSC can occur in an acute or chronic form. However, there is no agreement in the literature concerning the duration of the two forms. Some authors define CSC as chronic if there is persistent subretinal fluid for at least 6 months 11, others speak of chronic CSC when symptoms last longer than 3 months. In contrast there are studies where CSC is defined acute within the first 4 months. Spontaneously absorption is possible in up to 50% and normally leads to the recurrence of a normal visual acuity. Chronic CSC can result in a wide spread RPE damage and in a constantly reduction of visual acuity.

Structural changes in the retina and RPE have been found about 2 months after onset of the disease. Those changes can cause accumulation of photoreceptor outer segments, lead to consecutive atrophy of the photoreceptor cells and are associated with a loss of visual acuity.

Different concepts of treatment exist, but none of these may be deemed to be the golden standard. In the past few years several studies where CSC was treated with photodynamic therapy (PDT) or half-fluence PDT showed good visual outcomes and morphologic reconstitution. However, PDT is a destructive method which causes structural damage and can trigger other severe complications like choroidal ischemia and iatrogenic CNV. Furthermore, CSC is a self-limiting disease in many cases and physicians often hesitate to perform a relatively destructive therapeutical approach to treat a potentially self-limiting disease.

A newer, non-destructive therpeutical concept is the oral use of eplerenone a mineralocorticoid receptor antagonist. It is currently used in the treatment of hypertension and congestive heart failure. In the recent literature it was shown that eplerenone improved CSC and no serious adverse effects were observed in any case. However, no randomised controlled studies were performed comparing eplerenone with placebo to evaluate the clinical effect.


Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Drug: Eplerenone Drug: Maltodextrin Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Placebo Controlled Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy
Study Start Date : October 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Placebo Comparator: Sugar pill

Maltodextrin filled into capsules.

1 Pill starting dosage

Follow-up visits (every two weeks, beginning at week 4):

  • If subretinal fluid is present and the patient takes two pills a day dosage stays the same.
  • If no subretinal fluid is present, the patient will continue the present dosage for another 2 weeks and will then stop the medication.
  • If no subretinal fluid is present and the patient takes no medication everything stays the same.
  • If subretinal fluid is present again (recurrence) and the patient takes no medication, the medication will be re-started again, the patient has to take one tablet beginning at the following day
Drug: Maltodextrin
Experimental: Eplerenone

Eplerenone 25mg pills triturated and filled into capsules.

1 Pill starting dosage

Follow-up visits (every two weeks, beginning at week 4):

  • If subretinal fluid is present and the patient takes two pills a day dosage stays the same.
  • If no subretinal fluid is present, the patient will continue the present dosage for another 2 weeks and will then stop the medication.
  • If no subretinal fluid is present and the patient takes no medication everything stays the same.
  • If subretinal fluid is present again (recurrence) and the patient takes no medication, the medication will be re-started again, the patient has to take one tablet beginning at the following day
Drug: Eplerenone



Primary Outcome Measures :
  1. Difference in the number of successful treatments after 16 weeks, defined as complete absence of subretinal fluid on SD-OCT [ Time Frame: 16 weeks ]
    Difference in the number of successful treatments after 16 weeks, defined as complete absence of subretinal fluid on SD-OCT, between the study and the control groups. The final evaluation will be performed by an external retina specialist. Significance testing will be performed using Fischer's exact test.


Secondary Outcome Measures :
  1. Changes in visual acuity between eplerenone and placebo. [ Time Frame: 16 weeks ]
  2. Changes in retinal thickness between eplerenone and placebo. [ Time Frame: 16 weeks ]
  3. Changes in retinal volume between eplerenone and placebo. [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from untreated CSC for less than two months
  • Age 21 and older
  • Written informed consent

Exclusion Criteria:

  • Patients who have recently been treated with eplerenone
  • Pregnancy or patients who are currently breast-feeding
  • Patients who should not use eplerenone for any reason - an extensive internal medicine assessment will be performed in all patients prior to treatment start)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215330


Locations
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Austria
Oliver Findl Not yet recruiting
Vienna, Austria, 1140
Contact: Oliver Findl, MD, Prof, MBA    0043191021 ext 57568    ofindl@googlemail.com   
Principal Investigator: Oliver Findl, MD, Prof, MBA         
Sponsors and Collaborators
Prim. Prof. Dr. Oliver Findl, MBA
Investigators
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Principal Investigator: Oliver Findl, MD, Prof, MBA VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Prim. Univ-Prof. Dr. MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT02215330     History of Changes
Other Study ID Numbers: EPL
EK_14_170_0814 ( Other Identifier: Ethikkommission der Stadt Wien )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:
Central serous chorioretinopathy
Eplerenone
Photodynamic Therapy
Macula
Retina

Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents