We will present the study-design of our prospective randomized multi-center study that will start in autumn 2012.

Anti-VEGF-therapy has developed to the standard care for diabetic macular edema. ¬†Vitrectomy is an additional treatment option that is able to stabilize DME. The pharmacokinetic effect of a vitrectomy is an¬†increased VEGF-clearance in the eye, but also a higher clearance of intravitreally administered drugs. Consequently, vitrectomy should influence the number of Anti-VEGF injections. It remains unclear if the higher VEGF-clearance results in a smaller number of injections, or of the higher drug-clearance reduces the efficacy of the Anti-VEGF treatment with the consequence of a higher number of Anti-VEGF-injections in the first year after treatment. The goal of the planned prospective randomized multi-center study is to estimate the number of Anti VEGF-injections in the first year after a vitrectomy for DME. Patients will be randomized in two treatment groups. One group will be treated with Ranibizumab-injections, according to the label of the drug. In the second group, the same treatment is combined with vitrectomy with dye-assisted ILM-Peeling at the beginning of the one-year treatment period. Primary end point is the number of Ranibizumab injections in the first year of treatment. Secondary endpoints are the visual acuity, macular thickness in SD-OCT, quality of life, drop out rates and AE’s. Power analyses, based on the published results of the RESORE-study and on estimated effects of vitrectomy on the number of injections, showed a minimum number of 2 x 55 patients.