Clinical Trial: Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Study on Half-dose Photodynamic Therapy Versus Eplerenone in Chronic CenTRAl Serous Chorioretinopathy (SPECTRA Trial)
Brief 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 e
Detailed 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 e
Sponsor: Leiden University Medical Center
Current Primary Outcome: Absence of subretinal fluid on OCT scan [ Time Frame: 3 months after (start) of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Macular sensitivity on microperimetry [ Time Frame: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment. ]Macular sensitivity on microperimetry
- Mean change in best-corrected visual acuity [ Time Frame: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment. ]Mean change in Early Treatment of Diabetic Retinopathy Study best-corrected visual acuity
- Vision-related quality of life as reported on the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) [ Time Frame: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment. ]Vision-related quality of life as reported on the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
- Number of cross-over treatments needed in each treatment arm [ Time Frame: During study. At the evaluation visit at 3 months after the (start of) treatment, a possible cross-over treatment can be performed. ]Number of cross-over treatments needed (half-dose photodynamic therapy to eplerenone treatment, and vice versa) in each treatment arm
- The long-term outcome both after successful treatment and after non-successful treatment [ Time Frame: One year and two year after (start of) therapy ]Persistent absence of subretinal fluid on OCT
- The number of (S)AEs in the 2 different treatment groups. [ Time Frame: At the several evaluation visits within the study, at 3 months, at 1 year, and at 2 years after (the start of) treatment ]The number of (S)AEs in the 2 different treatment groups.
Original Secondary Outcome: Same as current
Information By: Leiden University Medical Center
Dates:
Date Received: March 2, 2017
Date Started: February 20, 2017
Date Completion: February 2021
Last Updated: March 8, 2017
Last Verified: March 2017
