Treatment trial of chronic central serous chorioretinopathy
Research type
Research Study
Full title
A prospective randomized controlled multicentre trial comparing half-dose photodynamic therapy with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (the PLACE study: Photodynamic therapy versus micropulse LAser in chronic CEntral serous chorioretinopathy)
IRAS ID
110788
Contact name
Camiel Boon
Contact email
Sponsor organisation
Radboud University Nijmegen Medical Centre
Eudract number
2012-004555-36
Clinicaltrials.gov Identifier
Research summary
Chronic central serous chorioretinopathy (CSC) is a relatively frequent eye disease that often occurs in patients in the professionally active age range. In this disease, there is pooling of fluid under the central retina (the macula). This specific form of macular degeneration can cause permanent vision loss, image distortion, loss of color and contrast vision due to this fluid under the retina. 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 chronic CSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Micropulse laser (ML) therapy may also be effective in this disease.
The proposed study is the first prospective randomized controlled trial in chronic CSC. In this study, participants with chronic CSC will be randomized into two treatment groups, PDT or ML treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than ML treatment. Therefore, PDT treatment is challenged against ML treatment.
Treatment success will not only be based on anatomical improvement, but also on functional endpoints, which are most important from a patient’s perspective.
The study will take place in four large tertiary referral university hospitals in Europe that have extensive experience with conducting clinical trials (in Oxford, UK; Nijmegen, Netherlands; Cologne, Germany; and Paris, France). Each of these centres has confirmed sufficient funding to conduct the research. The study will last max. 8 months per participant. Each participant will come for 5 (in the case of 1 treatment) or 7 visits (in the case of 2 treatments). Study evaluations will be mostly part of regular clinical care. The whole study will last for max. 24 months.REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0387
Date of REC Opinion
30 Sep 2013
REC opinion
Further Information Favourable Opinion