November 15, 2013
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VIVID, VISTA trials: Aflibercept superior to laser treatment for DME

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NEW ORLEANS — Parallel studies testing separate regimens of aflibercept injections against laser photocoagulation found both drug regimens to work better than laser photocoagulation in patients with diabetic macular edema.

Reporting the primary results at 1 year of the VIVID and VISTA trials, Diana V. Do, MD, told colleagues at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting, “Eyes that were randomized to either dosing regimen of aflibercept had superior visual acuity outcomes compared to laser-treated eyes.”

In the two randomized, multicenter, double-masked trials in patients with clinically significant DME with central involvement, 406 eyes in the VIVID study and 466 eyes in the VISTA study were randomized 1:1:1 to receive 2 mg Eylea (aflibercept, Regeneron) given intravitreally every 4 weeks, 2 mg aflibercept given intravitreally every 8 weeks after five initial monthly doses or laser photocoagulation. Primary endpoint at week 52 was mean change in best corrected visual acuity.

“In fact, eyes that received aflibercept gained on average 10.5 to 12.5 letters of acuity at year 1,” Do said. Thirty-two percent to 41% of aflibercept-treated eyes gained 15 or more letters of acuity compared with 8% to 9% of laser-treated eyes, she said.

On average, aflibercept given every 8 weeks was similar to aflibercept given every 4 weeks, she said. Furthermore, there were no systemic safety signals associated with aflibercept through 1 year of treatment.

Disclosure: Do receives research support from Genentech and Regeneron.