August 22, 2011
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Expanded 1-year DA VINCI outcomes suggest continued visual gains for DME patients

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 Diana V. Do, MD
Diana V. Do

BOSTON — VEGF Trap-Eye may be associated with superior visual outcomes in patients with diabetic macular edema, according to a study presented here.

"VEGF Trap-Eye appears to be safe with treatment and follow-up through 1 year. In regards to efficacy, all doses and dosing regimens of VEGF Trap-Eye produced statistically significant improvements in visual acuity compared to the laser treatment group," Diana V. Do, MD, said at the American Society of Retina Specialists meeting.

One-year results for the multicenter, double-masked phase 2 DA VINCI study included data from 176 patients who were treated up to 52 weeks. Patients were randomized to one of five regimens: 0.5 mg of VEGF Trap-Eye (aflibercept ophthalmic solution, Regeneron) every 4 weeks, 2 mg of aflibercept every 4 weeks, 2 mg of aflibercept every 8 weeks after three initial monthly doses, 2 mg of aflibercept as-needed after three initial monthly doses, or as-needed laser therapy after initial laser photocoagulation.

Eyes that received aflibercept gained 9.7 to 13 letters of visual acuity, compared with a mean loss of one letter for eyes treated with laser; 24% to 46% of aflibercept eyes gained 15 or more letters, compared with 12% of laser eyes. Eyes treated with aflibercept were also associated with a greater reduction in retinal thickening and improvements in diabetic retinopathy.

No serious ocular or systemic events were demonstrated, and a phase 3 randomized clinical trial is currently under way. Dr. Do said that initial data from the VIEW-1, VIEW-2 and DA VINCI studies suggest that aflibercept may be as efficacious as other anti-VEGF therapies but with fewer required doses.

  • Disclosure: Dr. Do's employer, Johns Hopkins University, receives research support from Regeneron and Genentech. The DA VINCI study is sponsored by Regeneron and Bayer.