Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy — SPECT  

Chronic Central Serous Chorioretinopathy Clinical Trial

Official title: Study on Half-dose Photodynamic Therapy Versus Eplerenone in Chronic CenTRAl Serous Chorioretinopathy (SPECTRA Trial)

Status Active, not recruiting

Clinical Trial Summary

Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye disease that is often diagnosed in patients in the professionally active age range. In this disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and the retinal pigment epithelium. This specific form of macular degeneration can cause permanent vision loss, image distortion, and loss of color and contrast vision. An early diagnosis and treatment may improve the visual outcome and quality of life.

To date there is no international consensus on the optimal treatment of cCSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Treatment with oral eplerenone may also be effective in this disease.

In this proposed prospective randomized controlled trial, cCSC patients will be randomized into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than eplerenone treatment.

The null hypothesis of the study is that PDT treatment is more effective than eplerenone treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is not superior to eplerenone treatment.

Treatment success will not only be based on characteristics on ophthalmological imaging, but also on functional endpoints (both on the outcome of questionnaires, best-corrected visual acuity, and microperimetry), which are most important from a patient's perspective.

The study will take place in 3 large tertiary referral university hospitals in The Netherlands that have extensive experience with conducting clinical trials (Academic Medical Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the Radboud University Medical Center and the Leiden University Medical Center have been involved in the first prospective randomized controlled trial that is currently conducted in cCSC.

This study will last 2 years per participant. Each participant will visit the outpatient clinic for a maximum number of 6 visits.

A total number of 107 patients will be included in the trial. Depending on the speed of inclusion of patients in this trial, the total duration of this study can be determined.

Clinical Trial Description

Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye disease that is often diagnosed in patients in the professionally active age range. In this disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and the retinal pigment epithelium. This specific form of macular degeneration can cause permanent vision loss, image distortion, and loss of color and contrast vision. An early diagnosis and treatment may improve the visual outcome and quality of life.

To date there is no international consensus on the optimal treatment of cCSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Treatment with oral eplerenone may also be effective in this disease.

In this proposed prospective randomized controlled trial, cCSC patients will be randomized into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than eplerenone treatment.

The null hypothesis of the study is that PDT treatment is more effective than eplerenone treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is not superior to eplerenone treatment.

Treatment success will not only be based on characteristics on ophthalmological imaging, but also on functional endpoints (both on the outcome of questionnaires, best-corrected visual acuity, and microperimetry), which are most important from a patient's perspective.

The study will take place in 3 large tertiary referral university hospitals in The Netherlands that have extensive experience with conducting clinical trials (Academic Medical Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the Radboud University Medical Center and the Leiden University Medical Center have been involved in the first prospective randomized controlled trial that is currently conducted in cCSC.

This study will last 2 years per participant. Each participant will visit the outpatient clinic for a maximum number of 6 visits, depending on the outcome of treatment. Study evaluations will be mostly part of regular clinical care.

A total number of 107 patients will be included in the trial. Depending on the speed of inclusion of patients in this trial, the total duration of this study can be determined. ;

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Chronic Central Serous Chorioretinopathy

• NCT number: NCT03079141
• Study type: Interventional
• Source: Leiden University Medical Center
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 20, 2017
• Completion date: August 2021