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One-year DA VINCI outcomes show sustained efficacy, safety for anti-VEGF
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NEW YORK — Clinical results through 52 weeks suggest sustained efficacy and safety for aflibercept in treating diabetic macular edema, a speaker here said.
"VEGF Trap-Eye produced statistically significant improvements in visual acuity, both at the primary endpoint at week 24 and through 52 weeks of follow-up and treatment. In addition to the visual acuity effects, also beneficial was the reduction in OCT retinal thickness," Diana Do, MD, said at Macula 2012.
The prospective, randomized, multicenter, phase 2 DA VINCI trial included 219 subjects assigned to one of five treatment groups: 2 mg or 0.5 mg Eylea (aflibercept, Regeneron Pharmaceuticals), also known as VEGF Trap-Eye, every 4 weeks; 2 mg aflibercept every 8 weeks or as-needed following three monthly loading doses; or focal grid laser.
Notably, over 52 weeks, approximately 7.4 injections were given to eyes in the as-needed group. Also, while most baseline characteristics were balanced, a higher proportion of those receiving aflibercept had cardiac history.
All aflibercept doses and regimens produced superior visual acuity results, Dr. Do said. Eyes treated with aflibercept gained, on average, 8.5 to 11.4 letters at month 6, compared with 2.5 letters for the laser group. By week 52, aflibercept eyes gained 9.7 to 13.1 letters, compared with a 1-letter loss for laser eyes; moreover, 45% to 71% of eyes gained 10 letters or more, and 24% to 46% of eyes gained 15 letters or more.
"In regards to safety, VEGF Trap-Eye was well-tolerated, and the most common ocular adverse events were those typical and previously described for VEGF inhibitors," Dr. Do noted.
Aflibercept eyes also had a significantly greater reduction in retinal thickness, and approximately 52% to 74% had no center-involved diabetic macular edema at 1 year.
"Because of these positive phase 2 results, a phase 3 randomized clinical trial is currently under way to further investigate VEGF Trap-Eye for diabetic macular edema," Dr. Do said.
- Disclosure: Dr. Do's employer, Johns Hopkins University, has received research funding from Regeneron and Genentech. The DA VINCI Study was co-sponsored by Regeneron and Bayer Healthcare.