Original articleOne-Year Outcomes of the DA VINCI Study of VEGF Trap-Eye in Eyes with Diabetic Macular Edema
Section snippets
Patients and Methods
The DA VINCI study was a randomized, double-masked, active-controlled multicenter phase 2 clinical trial. Thirty-nine sites in the United States, Canada, and Austria participated in the trial, and patients were enrolled between December 2008 and June 2009. The primary objective was to assess the efficacy of various doses and dose intervals of intravitreal VEGF Trap-Eye (aflibercept injection) on BCVA. The primary end point was the change in BCVA from baseline to week 24. Secondary objectives
Patient Disposition and Demographics
A total of 221 eyes were randomized, 219 were treated, and 176 completed the 52-week study (Table 1, available at http://aaojournal.org). Forty-three patients discontinued the study after receiving at least 1 treatment for the following reasons: lost to follow-up (n = 11), withdrew consent (n = 11), death (n = 6), treatment failures (n = 2), AE (n = 7), protocol deviation (n = 2), other (n = 4). Discontinuations were distributed evenly among all the treatment groups. Demographic information and
Discussion
In this phase 2 clinical trial, all VEGF Trap-Eye doses and dosing regimens were found to be superior to macular laser photocoagulation for the treatment of DME over the course of 52 weeks and produced similar results in terms of preserving and improving visual acuity. Patients who received VEGF Trap-Eye benefited from significantly greater increases in mean visual acuity at 1 year (+9.7 to +13.1 letters of improvement) compared with laser treatment alone (−1.3 letters change; P<0.0001).
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Manuscript no. 2011-1202.
Financial Disclosure(s): The author(s) have made the following disclosure(s): Diana V. Do, Financial support, Genentech, Regeneron Pharmaceuticals; Quan Dong Nguyen, Financial support, Genentech, Regeneron Pharmaceuticals; David Boyer, Consultant, Genentech, Regeneron Pharmaceuticals, IÇO, Allergan; Lecturer, Genentech, Regeneron Pharmaceuticals, Allergan; Ursula Schmidt-Erfuth, Consultant, Alcon Labs, Bayer Healthcare, Novartis; Lecturer, Alcon Labs, Bayer Healthcare, Novartis, Regeneron Pharmaceuticals, Pfizer; David Brown, Consultant, Genentech, Regeneron Pharmaceuticals, Allergan; Lecturer, Genentech, Regeneron Pharmaceuticals, Allergan; Robert Vitti, Employee, Equity owner, Regeneron Pharmaceuticals; Alyson Berliner, Employee, Equity owner, Regeneron Pharmaceuticals; Oliver Zeitz, Employee, Bayer Healthcare; Rene Ruckert, Employee, Bayer Healthcare; Thomas Schmelter, Employee, Bayer Healthcare; Rupert Sandbrink, Employee, Bayer Healthcare; Jeff S. Heier, Consultant, Genentech, Regeneron Pharmaceuticals, Fovea; Lecturer, Genentech, Regeneron Pharmaceuticals.
Sponsored by Regeneron Pharmaceuticals, Inc, Tarrytown, New York, and Bayer Healthcare, Berlin, Germany.
A list of principal investigators of the DME And VEGF Trap-Eye: INvestigation of Clinical Impact Study is available at http://aaojournal.org.