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

NCT02215330 | Unknown Phase 2

• 2 other identifiers: EPLEK_14_170_0814
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Serous Chorioretinopathy

Keywords

Central serous chorioretinopathy; Eplerenone; Photodynamic Therapy; Macula; Retina

Outcome Measures

Primary Outcomes (1)

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

  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.

  16 weeks

Secondary Outcomes (3)

• Changes in visual acuity between eplerenone and placebo.

  16 weeks

• Changes in retinal thickness between eplerenone and placebo.

  16 weeks

• Changes in retinal volume between eplerenone and placebo.

  16 weeks

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

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

Eplerenone

EXPERIMENTAL

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

Interventions

Eplerenone DRUG

Eplerenone

Maltodextrin DRUG

Sugar pill

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prim. Prof. Dr. Oliver Findl, MBA: lead

Study Sites (1)

Oliver Findl

Vienna, 1140, Austria

Location

Related Publications (1)

• Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.

  PMID: 40522203 DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Eplerenone; maltodextrin

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Oliver Findl, MD, Prof, MBA

  VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prim. Univ-Prof. Dr. MBA

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 13, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

AU (1)