The DA VINCI Study (Diabetic Macular Edema And VEGF Trap-Eye: Investigation Of Clinical Impact): 1-Year Results

Peter Kaiser

Purpose: To determine whether different doses and dosing regimens of intravitreal VEGF Trap-Eye are superior to focal/grid photocoagulation in eyes with diabetic macular edema (DME) over one year of treatment.

Methods: In this double-masked, multicenter, Phase 2 study, patients with clinically significant macular edema were randomized to VEGF Trap-Eye 0.5 mg every 4 weeks, 2 mg every 4 weeks, 2 mg every 8 weeks following 3 monthly loading doses, 2 mg PRN following 3 monthly loading doses, or laser photocoagulation. Main outcome measures are the mean change in visual acuity and central retinal thickness.

Results: Six month (primary endpoint) results have shown that VEGF Trap-Eye significantly improved visual acuity when compared to macular laser photocoagulation. VEGF Trap-Eye was generally well tolerated, with the most frequent ocular adverse event being conjunctival hemorrhage, occurring in 19% of VEGF Trap-Eye-treated eyes and 18% of laser-treated eyes. 1-yr data from this study will become available by the end of 2010; these efficacy and safety results will be presented and discussed.

Conclusions: The 1-yr results of DA VINCI will provide important information regarding the relative efficacy and safety of VEGF Trap-Eye in patients with DME