VEGF Trap improves visual acuity, foveal thickness at higher doses

CANCUN, Mexico — Higher doses of VEGF Trap show more bioactivity and a longer lasting improvement in vision and foveal thickness compared with lower doses in patients with age-related macular degeneration, according to a surgeon speaking here.

Quan D. Nguyen, MD, presented the interim results from a study of VEGF Trap-Eye (Regeneron Pharmaceuticals) during subspecialty day at the Pan-American Association of Ophthalmology meeting.

According to Dr. Nguyen, phase 1 of three phases has been completed and phase 2 data is still being collected.

The phase 1 trial included 28 AMD patients given VEGF Trap-Eye doses of either 0.15 mg or 4 mg.

Investigators found that both doses resulted in similar decreases in lesion thickness at 2 weeks. But the 4-mg dose showed a significantly better effect at 8 weeks, Dr. Nguyen said.

"By week 8, the 4-mg dose produced a much better effect and fewer patients required re-treatment," he said.

The results also showed the mean time to the second dose was 78 days with the 0.15-mg dose compared with 109 days with the 4-mg dose, he noted.

Interim results for the phase 2 study included data for 78 patients randomly assigned to receive either 0.5 mg, 2 mg or 4 mg of VEGF Trap-Eye at different time points. The results showed a six letter increase in visual acuity at 12 weeks. However, there was still a difference in treatment effect between the doses.

"The 2-mg and 4-mg doses showed more bioactivity, and the effects lasted 8 weeks or longer," Dr. Nguyen said. "Overall, 99% of patients either maintained or improved visual acuity at 12 weeks."