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临床试验/NCT02215330
NCT02215330Unknown2 期

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

Prim. Prof. Dr. Oliver Findl, MBA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
60
试验地点
1
主要终点
Difference in the number of successful treatments after 16 weeks, defined as complete absence of subretinal fluid on SD-OCT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究组 & 干预措施

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

干预措施: Maltodextrin (Drug)

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

干预措施: Eplerenone (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Prim. Prof. Dr. Oliver Findl, MBA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Prim. Univ-Prof. Dr. MBA

Vienna Institute for Research in Ocular Surgery

研究点 (1)

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