An Open Label Clinical Trial of Ranibizumab for Diabetic Macular Oedema resistant to Intravitreal Triamcinolone

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Diabetic macular oedema (DMO) is thought to result from a series of biochemical and cellular changes, causing progressive leakage and exudation. Focal and grid photocoagulation remains the standard care for diabetic maculopathy. However, the availability of new agents raises the possibility of improvements in outcomes. Vascular endothelial growth factor (VEGF) levels have been found to be elevated in the aqueous and vitreous humour of patients with DMO.The study is designed to confirm the efficacy and safety of ranibizumab (0.3 mg), an anti-VEGF agent, as therapy in patients with visual impairment due to DMO, in whom current treatments of intravitreal injections of triamcinolone (IVTA) is no longer effective. The primary objective of this study is to determine whether ranibizumab 0.3 mg given as monthly intravitreal injections is effective in patients who meet the criteria for steroid (IVTA) resistence, defined as: - An improvement in VA of less than 5 letters - A reduction in central retinal thickness in OCT of less than 100 microns (or less than 20%, whichever is greater) 6 weeks after treatment with IVTA for at least 2 consecutive injections RESEARCH DESIGN AND METHODS We will, after investigations to exclude any other cause of visual loss, conduct an open label study to administer intravitreal injections of 0.3 mg of ranibizumab at four weekly intervals to all enrolled patients, with a minimum 4 injections planned with additional doses at the same interval if clinically indicated at the discretion of the Investigator for up to 12 months. All patients will be followed for at least 12 months.

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