Clinical Trial: A Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Detailed 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
Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in visual acuity between eplerenone and placebo. [ Time Frame: 16 weeks ]
  • Changes in retinal thickness between eplerenone and placebo. [ Time Frame: 16 weeks ]
  • Changes in retinal volume between eplerenone and placebo. [ Time Frame: 16 weeks ]


Original Secondary Outcome: Same as current

Information By: Vienna Institute for Research in Ocular Surgery

Dates:
Date Received: August 11, 2014
Date Started: October 2014
Date Completion: September 2017
Last Updated: August 12, 2014
Last Verified: August 2014