Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema (TDMX study)

We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular oedema that persists or recurs after laser treatment. Sixty four of the originally enrolled 69 (93%) eyes are available to be followed. The primary outcome measures will be an increase of =5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit. The incidence of moderate or severe adverse events over the 3 years of the open-label extension will also be a primary outcome. Secondary outcomes will include change in macular thickness by OCT, any change in visual acuity and number of laser treatments required. Standardised protocols have been developed for intravitreal injection, macular laser treatment, refraction and measurement of visual acuity. Treatment with triamcinolone will be offered to all patients, whether they previously received placebo or active treatment, on exit from the TDMO study. IVTA will be administered in the clinic under local anaesthesia. Treatments will be given at least 6 months apart according to prospectively identified criteria that take into account the previous and current visual acuity and macular thickness measured by OCT. The safety data will be monitored 6 monthly by an independent Safety Monitoring Committee.