Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy
Status:
Unknown status
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Radboud University