Triamcinolone versus Inner–Limiting Membrane Peeling for Diffuse Macular Edema (TIME Study): Design Issues and Implications

Abstract

Abstract: : Background: Treatment results for persistent diabetic macular edema remain disappointing. Although grid laser therapy might reduce retinal thickness in selected cases, there are severe side effects such as visual field loss and pigment epithelial scarring. Currently two very different treatment approaches are being investigated: ILM Peeling and intravitreal triamcinolone, which both have been demonstrated to be effective in case series. Still there is no evidence which one is superior to the other in and in which specific group of patients. The Triamcinolone versus ILM Peeling in Diabetic Macular Edema Study (TIME–Study) is designed to investigate the efficacy of the two treatments in patients with persistent diabetic macular edema. Methods/Results:The TIME Study is a multicentre, randomised, controlled clinical trial stratified by surgeon. Patients with persistent (diffuse or focal) diabetic macular edema (more than 6 months) can be included and are randomized to either the control group (no treatment), ppV+ILM peeing or triamcinolone (4mg) injection. 405 consecutive patients are to be recruited per group and followed up for 1 year. The main endpoint criteria are the change in VA at the twelve months timepoint as compared to the initial VA and the change in retinal thickness for the respective period of time. Secondary endpoints include measures of difference in the functional success (course of visual acuity, ETDRS and reading performance, ischemic maculopathy) between the treatment groups and the effect of the treatment on the patient's quality of life. So far, sixteen institutions (21 surgeons) in 5 european countries agreed to contribute to the study. Conclusions: The TIME Study is a randomised prospective clinical trial to investigate the effectiveness of triamcinolone acetonide and ILM Peeling in the treatment of persistent diffuse diabetic macular edema. The results of this study should enable physicians to improve therapy in this devastating condition and to select the cases according to the most promising treatment option.

Keywords: diabetes • macula/fovea • vitreoretinal surgery