Cross-Over and Long Term Follow Up Study Following the PLACE Trial

• Research type

  Research Study

• Full title

  LONG-TERM FOLLOW-UP AND CROSS-OVER OF TREATMENT WITH HIGH-DENSITY MICROPULSE LASER AND HALF-DOSE PHOTODYNAMIC THERAPY IN PARTICIPANTS OF THE PLACE TRIAL FOR CHRONIC CENTRAL SEROUS CHORIORETINOPATHY

• IRAS ID

  171958

• Contact name

  Camiel J.F Boon

• Contact email

  C.J.F.Boon@lumc.nl

• Sponsor organisation

  Radboud University Nijmegen Medical Centre

• Duration of Study in the UK

  2 years, 0 months, 2 days

• Research summary

  The Cross Over and Long term Follow up study is designed to continue to review and provide treatment to those participants of the PLACE trial.
  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 colour 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. This was the objective of the PLACE trial and it is now important to follow up these participants to assess the long term outcome. Those participants who have responded to treatment will be monitored at baseline (the final PLACE visit) and 1 year later. Those participants who have not responded to their randomised treatment in the PLACE trial (either ML or PDT) will receive the alternative form of treatment. (i.e cross-over) The success of the treatment outcomes will be measured upon the absence of sub retinal fluid with Ocular Coherance Tomography imaging, evaluation of best corrected visual acuity,retinal sensitivity on microperimetry and subjective success scores with visual functional questionnaires.
  5 tertiary referral university hospitals in Europe will conduct this clinical trial : Oxford, UK; Nijmegen and Leiden, Netherlands; Cologne, Germany; and Paris, France) Each centre has confirmed sufficient funding to conduct the research which will be mostly part of regular clinical care. The whole study will last for max. 24 months.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  15/SC/0313

• Date of REC Opinion

  21 Jul 2015

• REC opinion

  Further Information Favourable Opinion