Aflibercept (Eylea, formerly VEGF Trap-Eye, Regeneron Pharmaceuticals/Bayer HealthCare) was safe and provided significant benefit in the treatment of diabetic macular edema (DME), according to a paper presented at the 2011 ASRS meeting.1
Diana V. Do, MD, Assistant Professor of Ophthalmology at the Wilmer Eye Institute, Johns Hopkins School of Medicine in Baltimore, Maryland, presented the results of the DA VINCI study, a double-masked randomized prospective multicenter phase 2 study that included 219 patients (219 eyes) who were randomized and treated with either aflibercept or photocoagulation. The aflibercept group was divided into four groups: aflibercept 0.5 mg every 4 weeks (0.5q4); 2 mg every 4 weeks (2q4); 2 mg every 8 weeks following 3 initial monthly doses (2q8); and 2 mg as needed following 3 initial monthly doses (2PRN). Eligible patients had clinically significant DME with central involvement, defined as thickness of greater than 250 μm in the central subfield on optical coherence tomography (OCT), and best corrected visual acuity (BCVA) of between 20/40 and 20/320 Snellen equivalent.
The change in BCVA was measured at week 24 (primary endpoint) and week 52. Additional secondary endpoints assessed at week 52 included the proportion of patients who gained ≥15 letters in BCVA and mean change in central retinal thickness from baseline.
In the 176 patients who followed to the completion of the study at 1 year, eyes that were randomized to aflibercept gained 9.7 to 13.1 letters, compared with a 1.3 letter loss in the laser group (P < .0001). No statistically significant differences were observed among the groups that received aflibercept. Also at 1 year, 45% to 71% of eyes treated with aflibercept gained 10 or more letters; and 24% to 46% of eyes treated with aflibercept gained 15 or more letters, compared with 12% of eyes in the laser-treated group, Dr. Do said.
At 6 months, central retinal thickness on OCT was greater in the aflibercept treatment groups than in the laser group (P < .0001). The greatest decrease at 6 months, -194.5 μm from baseline, was seen in the 2q4 treatment arm, although the differences among the aflibercept treatment arms were not statistically significant. The decreases in thickness seen at 6 months were maintained or numerically improved at 1 year.
“All doses and dosing regimens of [aflibercept] produced statistically significant improvements in visual acuity compared to the laser treatment group. And these improvements were associated with a greater reduction in anatomic retinal thickening on OCT,” Dr. Do said. “Because of these positive phase 2 results, a phase 3 randomized clinical trial is currently underway to further investigate [aflibercept] for diabetic macular edema.”
In addition to improving visual acuity, aflibercept was also associated with an improvement in diabetic retinopathy. At 1 year, 31% to 64% of eyes treated with aflibercept had an improvement in their diabetic retinopathy improvement scale, compared with 12% of eyes in the laser-treated group, Dr. Do said.
Aflibercept was generally well tolerated. There were 2 cases of injection-related endophthalmitis, but no serious ocular adverse events were related to the study drug. Additionally, there were no serious systemic adverse events. Six deaths occurred in the 175 patients who received the study drug (3.4%) and 1 death occurred in the 44 patients who were treated with laser (2.3%) over the course of 1 year. Dr. Do said that none of the deaths were attributed to the study drug, and most were due to the patients' underlying medical illness.
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