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

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Brief Title

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

Official Title

A Randomized, Double-masked, Placebo Controlled Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy

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.
    

Detailed Description

      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.

      Aim of this randomised controlled double-masked study is to compare the treatment effects of
      eplerenone versus placebo in patients with acute or chronic CSC with an untreated
      observational period of at least 2 months. If there is no sign of clinical improvement within
      the first 16 weeks after the onset of symptoms, patients will be offered half-fluence PDT.

      In smaller case series, eplerenone was shown to be a valuable therapeutical option for
      patients suffering from CSC, but no randomised studies are available. The oral application
      was well tolerated by the patients and no severe side effects occurred.

      The most common side effect of eplerenone is hyperkalemia making close monitoring in
      individuals with diabetes mellitus or renal disease necessary. In our study, blood tests
      according to the standard for eplerenone will be performed for all patients. Additionally,
      all patients in the study will be seen and examined by an internal medicine specialist
      sub-specialized in endocrinology prior to treatment and during the entire duration of the
      study.

      Patients suffering from CSC included in this study will either receive eplerenone or placebo
      tablets. The treatment will start 2 months after recognition of first symptoms at the
      earliest. Therefore, patients with acute CSC are not missing out on treatment, as the usual
      "treatment" in this phase is observation only. Patients in the eplerenone group may benefit
      from taking part in this study, whereas patients in the control group will undergo the
      standard treatment (=observation only). Our current treatment protocol is to perform a
      half-fluence PDT approximately 4 months after onset of symptoms. All patients that do not
      improve within this time period will be offered to receive a half-fluence PDT. In the case of
      chronic CSC, with onset of symptoms or diagnosis more than 2 months of duration, eplerenone
      or placebo will nevertheless be offered with the above mentioned treatment period of 2 months
      and the rescue therapy option of half-fluence PDT in case of no signs of a positive treatment
      effect within 4 months of eplerenone therapy.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Difference in the number of successful treatments after 16 weeks, defined as complete absence of subretinal fluid on SD-OCT

Secondary Outcome

 Changes in visual acuity between eplerenone and placebo.

Condition

Central Serous Chorioretinopathy

Intervention

Eplerenone

Study Arms / Comparison Groups

 Sugar pill
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

October 2014

Completion Date

September 2017

Primary Completion Date

March 2017

Eligibility 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)
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Oliver Findl, MD, Prof, MBA, , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT02215330

Organization ID

EPL

Secondary IDs

EK_14_170_0814

Responsible Party

Sponsor-Investigator

Study Sponsor

Prim. Prof. Dr. Oliver Findl, MBA


Study Sponsor

Oliver Findl, MD, Prof, MBA, Principal Investigator, VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140


Verification Date

August 2014