<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02215330</url>
  </required_header>
  <id_info>
    <org_study_id>EPL</org_study_id>
    <secondary_id>EK_14_170_0814</secondary_id>
    <nct_id>NCT02215330</nct_id>
  </id_info>
  <brief_title>A Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy</brief_title>
  <official_title>A Randomized, Double-masked, Placebo Controlled Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Prof. Dr. Oliver Findl, MBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vienna Institute for Research in Ocular Surgery</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Central serous chorioretinopathy (CSC) is supposedly the fourth most common non-surgical&#xD;
      retinopathy after age-related macular degeneration, diabetic retinopathy and branch retinal&#xD;
      vein occlusion. The disease was first described by Albrecht von Graefe in 1866 as a&#xD;
      'recurrent central retinitis' and is nowadays commonly known as 'central serous&#xD;
      chorioretinopathy', a term mainly coined by Donald Gass in the late 1960s.&#xD;
&#xD;
      Although the disease has been known for decades, the underlying mechanism is not yet fully&#xD;
      understood. Numerous studies have shown an involvement of the retinal pigment epithelium&#xD;
      (RPE) and the choroid which lead to accumulation of subretinal fluid with subsequent&#xD;
      detachment of the neurosensory retina.&#xD;
&#xD;
      Among several assumed risk factors, high serum glucocorticoid levels seem to be related to&#xD;
      the occurrence of CSC.&#xD;
&#xD;
      CSC typically affects young, male patients unilaterally and causes decreased and distorted&#xD;
      vision, often associated with metamorphopsia, micropsia, dyschromatopsia and reduced contrast&#xD;
      sensitivity. CSC can occur in an acute or chronic form. However, there is no agreement in the&#xD;
      literature concerning the duration of the two forms. Some authors define CSC as chronic if&#xD;
      there is persistent subretinal fluid for at least 6 months 11, others speak of chronic CSC&#xD;
      when symptoms last longer than 3 months. In contrast there are studies where CSC is defined&#xD;
      acute within the first 4 months. Spontaneously absorption is possible in up to 50% and&#xD;
      normally leads to the recurrence of a normal visual acuity. Chronic CSC can result in a wide&#xD;
      spread RPE damage and in a constantly reduction of visual acuity.&#xD;
&#xD;
      Structural changes in the retina and RPE have been found about 2 months after onset of the&#xD;
      disease. Those changes can cause accumulation of photoreceptor outer segments, lead to&#xD;
      consecutive atrophy of the photoreceptor cells and are associated with a loss of visual&#xD;
      acuity.&#xD;
&#xD;
      Different concepts of treatment exist, but none of these may be deemed to be the golden&#xD;
      standard. In the past few years several studies where CSC was treated with photodynamic&#xD;
      therapy (PDT) or half-fluence PDT showed good visual outcomes and morphologic reconstitution.&#xD;
      However, PDT is a destructive method which causes structural damage and can trigger other&#xD;
      severe complications like choroidal ischemia and iatrogenic CNV. Furthermore, CSC is a&#xD;
      self-limiting disease in many cases and physicians often hesitate to perform a relatively&#xD;
      destructive therapeutical approach to treat a potentially self-limiting disease.&#xD;
&#xD;
      A newer, non-destructive therpeutical concept is the oral use of eplerenone a&#xD;
      mineralocorticoid receptor antagonist. It is currently used in the treatment of hypertension&#xD;
      and congestive heart failure. In the recent literature it was shown that eplerenone improved&#xD;
      CSC and no serious adverse effects were observed in any case. However, no randomised&#xD;
      controlled studies were performed comparing eplerenone with placebo to evaluate the clinical&#xD;
      effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Central serous chorioretinopathy (CSC) is supposedly the fourth most common non-surgical&#xD;
      retinopathy after age-related macular degeneration, diabetic retinopathy and branch retinal&#xD;
      vein occlusion. The disease was first described by Albrecht von Graefe in 1866 as a&#xD;
      'recurrent central retinitis' and is nowadays commonly known as 'central serous&#xD;
      chorioretinopathy', a term mainly coined by Donald Gass in the late 1960s.&#xD;
&#xD;
      Although the disease has been known for decades, the underlying mechanism is not yet fully&#xD;
      understood. Numerous studies have shown an involvement of the retinal pigment epithelium&#xD;
      (RPE) and the choroid which lead to accumulation of subretinal fluid with subsequent&#xD;
      detachment of the neurosensory retina.&#xD;
&#xD;
      Among several assumed risk factors, high serum glucocorticoid levels seem to be related to&#xD;
      the occurrence of CSC.&#xD;
&#xD;
      CSC typically affects young, male patients unilaterally and causes decreased and distorted&#xD;
      vision, often associated with metamorphopsia, micropsia, dyschromatopsia and reduced contrast&#xD;
      sensitivity. CSC can occur in an acute or chronic form. However, there is no agreement in the&#xD;
      literature concerning the duration of the two forms. Some authors define CSC as chronic if&#xD;
      there is persistent subretinal fluid for at least 6 months 11, others speak of chronic CSC&#xD;
      when symptoms last longer than 3 months. In contrast there are studies where CSC is defined&#xD;
      acute within the first 4 months. Spontaneously absorption is possible in up to 50% and&#xD;
      normally leads to the recurrence of a normal visual acuity. Chronic CSC can result in a wide&#xD;
      spread RPE damage and in a constantly reduction of visual acuity.&#xD;
&#xD;
      Structural changes in the retina and RPE have been found about 2 months after onset of the&#xD;
      disease. Those changes can cause accumulation of photoreceptor outer segments, lead to&#xD;
      consecutive atrophy of the photoreceptor cells and are associated with a loss of visual&#xD;
      acuity.&#xD;
&#xD;
      Different concepts of treatment exist, but none of these may be deemed to be the golden&#xD;
      standard. In the past few years several studies where CSC was treated with photodynamic&#xD;
      therapy (PDT) or half-fluence PDT showed good visual outcomes and morphologic reconstitution.&#xD;
      However, PDT is a destructive method which causes structural damage and can trigger other&#xD;
      severe complications like choroidal ischemia and iatrogenic CNV. Furthermore, CSC is a&#xD;
      self-limiting disease in many cases and physicians often hesitate to perform a relatively&#xD;
      destructive therapeutical approach to treat a potentially self-limiting disease.&#xD;
&#xD;
      A newer, non-destructive therpeutical concept is the oral use of eplerenone a&#xD;
      mineralocorticoid receptor antagonist. It is currently used in the treatment of hypertension&#xD;
      and congestive heart failure. In the recent literature it was shown that eplerenone improved&#xD;
      CSC and no serious adverse effects were observed in any case. However, no randomised&#xD;
      controlled studies were performed comparing eplerenone with placebo to evaluate the clinical&#xD;
      effect.&#xD;
&#xD;
      Aim of this randomised controlled double-masked study is to compare the treatment effects of&#xD;
      eplerenone versus placebo in patients with acute or chronic CSC with an untreated&#xD;
      observational period of at least 2 months. If there is no sign of clinical improvement within&#xD;
      the first 16 weeks after the onset of symptoms, patients will be offered half-fluence PDT.&#xD;
&#xD;
      In smaller case series, eplerenone was shown to be a valuable therapeutical option for&#xD;
      patients suffering from CSC, but no randomised studies are available. The oral application&#xD;
      was well tolerated by the patients and no severe side effects occurred.&#xD;
&#xD;
      The most common side effect of eplerenone is hyperkalemia making close monitoring in&#xD;
      individuals with diabetes mellitus or renal disease necessary. In our study, blood tests&#xD;
      according to the standard for eplerenone will be performed for all patients. Additionally,&#xD;
      all patients in the study will be seen and examined by an internal medicine specialist&#xD;
      sub-specialized in endocrinology prior to treatment and during the entire duration of the&#xD;
      study.&#xD;
&#xD;
      Patients suffering from CSC included in this study will either receive eplerenone or placebo&#xD;
      tablets. The treatment will start 2 months after recognition of first symptoms at the&#xD;
      earliest. Therefore, patients with acute CSC are not missing out on treatment, as the usual&#xD;
      &quot;treatment&quot; in this phase is observation only. Patients in the eplerenone group may benefit&#xD;
      from taking part in this study, whereas patients in the control group will undergo the&#xD;
      standard treatment (=observation only). Our current treatment protocol is to perform a&#xD;
      half-fluence PDT approximately 4 months after onset of symptoms. All patients that do not&#xD;
      improve within this time period will be offered to receive a half-fluence PDT. In the case of&#xD;
      chronic CSC, with onset of symptoms or diagnosis more than 2 months of duration, eplerenone&#xD;
      or placebo will nevertheless be offered with the above mentioned treatment period of 2 months&#xD;
      and the rescue therapy option of half-fluence PDT in case of no signs of a positive treatment&#xD;
      effect within 4 months of eplerenone therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the number of successful treatments after 16 weeks, defined as complete absence of subretinal fluid on SD-OCT</measure>
    <time_frame>16 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in visual acuity between eplerenone and placebo.</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in retinal thickness between eplerenone and placebo.</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in retinal volume between eplerenone and placebo.</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Central Serous Chorioretinopathy</condition>
  <arm_group>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin filled into capsules.&#xD;
1 Pill starting dosage&#xD;
Follow-up visits (every two weeks, beginning at week 4):&#xD;
If subretinal fluid is present and the patient takes two pills a day dosage stays the same.&#xD;
If no subretinal fluid is present, the patient will continue the present dosage for another 2 weeks and will then stop the medication.&#xD;
If no subretinal fluid is present and the patient takes no medication everything stays the same.&#xD;
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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eplerenone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eplerenone 25mg pills triturated and filled into capsules.&#xD;
1 Pill starting dosage&#xD;
Follow-up visits (every two weeks, beginning at week 4):&#xD;
If subretinal fluid is present and the patient takes two pills a day dosage stays the same.&#xD;
If no subretinal fluid is present, the patient will continue the present dosage for another 2 weeks and will then stop the medication.&#xD;
If no subretinal fluid is present and the patient takes no medication everything stays the same.&#xD;
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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eplerenone</intervention_name>
    <arm_group_label>Eplerenone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <arm_group_label>Sugar pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from untreated CSC for less than two months&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have recently been treated with eplerenone&#xD;
&#xD;
          -  Pregnancy or patients who are currently breast-feeding&#xD;
&#xD;
          -  Patients who should not use eplerenone for any reason - an extensive internal medicine&#xD;
             assessment will be performed in all patients prior to treatment start)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oliver Findl, MD, Prof, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oliver Findl</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <contact>
      <last_name>Oliver Findl, MD, Prof, MBA</last_name>
      <phone>0043191021</phone>
      <phone_ext>57568</phone_ext>
      <email>ofindl@googlemail.com</email>
    </contact>
    <investigator>
      <last_name>Oliver Findl, MD, Prof, MBA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vienna Institute for Research in Ocular Surgery</investigator_affiliation>
    <investigator_full_name>Prim. Prof. Dr. Oliver Findl, MBA</investigator_full_name>
    <investigator_title>Prim. Univ-Prof. Dr. MBA</investigator_title>
  </responsible_party>
  <keyword>Central serous chorioretinopathy</keyword>
  <keyword>Eplerenone</keyword>
  <keyword>Photodynamic Therapy</keyword>
  <keyword>Macula</keyword>
  <keyword>Retina</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Central Serous Chorioretinopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eplerenone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02215330
org study id: EPL
secondary id: EK_14_170_0814
nct id: NCT02215330
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference in the number of successful treatments after 16 weeks, defined as complete absence of subretinal fluid on SD-OCT
time frame: 16 weeks
description: 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.
measure: Changes in visual acuity between eplerenone and placebo.
time frame: 16 weeks
measure: Changes in retinal thickness between eplerenone and placebo.
time frame: 16 weeks
measure: Changes in retinal volume between eplerenone and placebo.
time frame: 16 weeks
arm group label: Sugar pill
arm group type: Placebo Comparator
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
arm group label: Eplerenone
arm group type: Experimental
description: 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
intervention type: Drug
intervention name: Eplerenone
arm group label: Eplerenone
intervention type: Drug
intervention name: Maltodextrin
arm group label: Sugar pill
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Oliver Findl, MD, Prof, MBA
role: Principal Investigator
affiliation: VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
facility: 
contact: 
investigator: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Vienna Institute for Research in Ocular Surgery
investigator full name: Prim. Prof. Dr. Oliver Findl, MBA
investigator title: Prim. Univ-Prof. Dr. MBA
mesh term: Central Serous Chorioretinopathy
mesh term: Eplerenone