Ranibizumab in Diabetic Macular Oedema - the RESTORE study

This trial is sponsored by the pharmaceutical company Novartis. The study drug, Ranibizumab (Lucentis®), is given by injection into the eye.  Ranibizumab is currently approved for the treatment of age-related macular degeneration in many countries, including the UK. It is being evaluated as a new treatment but is not yet approved by the Health Authority for the treatment of people with diabetic macular oedema, an eye condition that can cause a form of blindness.     In an ongoing research study, Ranibizumab has been administered to approximately 100 patients with diabetic macular oedema for up to one year. While the purpose of this previous study was to assess the safety and how effective ranibizumab is when compared to no treatment, the purpose of the new study is to compare ranibizumab with the current standard treatment for diabetic macular oedema, which is laser treatment. This research study will be taking place in about 60 hospitals located in European countries and in other parts of the world. There will be approximately 315 patients taking part in this study and the study will last for approximately 12 months. During this time patients will be asked to come to the clinic for at least 14 visits. The duration of the visits will depend on the procedures required by the study protocol. The procedures involved in the study are routine for diabetic macular oedema and involve eye tests, photographying the eye, blood tests and other imaging techniques for the eye. There will be three treatment types and patients will be randomly assigned to one of the following treatments: laser treatment, ranibizumab or laser and ranibizumab.