Triamcinolone versus inner-limiting membrane peeling in persistent diabetic macular edema (TIME study): design issues and implications

Abstract

Treatment options for persistent diabetic macular edema remain disappointing. ILM peeling and intravitreal triamcinolone have been successfully used in several case series; however, there is no evidence that one of these options is superior for specific groups of patients. The triamcinolone versus ILM peeling in diabetic macular edema study (TIME-study) is designed to investigate the efficacy of these two treatments in patients with persistent diabetic macular edema. Patients with persistent diabetic macular edema are randomised to either the control group (no treatment), ppV + ILM peeling, or triamcinolone (4 mg) injection. One hundred thirty-five patients are to be recruited per group and followed-up for one year. The main endpoints are defined as change in visual acuity (VA) at 12 months compared to baseline and the change in retinal thickness after 3 months follow-up. Secondary endpoints include differences in the functional success and anatomical success and the effect of the treatment on the patient's quality of life. Twelve institutions (28 surgeons) in 3 European countries agreed to contribute to the study. The design issues and implications of the study are described. The TIME study is the first randomised prospective clinical trial to investigate the effectiveness of the two treatment methods. The results of this study should enable physicians to improve therapy and to select cases according to the most promising treatment option.