Ranibizumab yields 15-letter gain in VA in patients treated for DME, study shows

SOUTH SAN FRANCISCO, Calif. — Results of the second of two phase 3 clinical trials showed that ranibizumab met its primary endpoint in patients being treated for diabetic macular edema, according to a news release from Genentech.

The study showed a significant gain in visual acuity among patients who received injections of Lucentis (ranibizumab, Genentech) compared with patients who received sham injections, according to the release.

"This data adds to the considerable body of clinical evidence showing that patients with DME who received Lucentis had significant improvement in vision," Hal Barron, MD, chief medical officer and head of global product development for Genentech, said in the release.

At 24 months, 42 of 125 patients (33.6%) who received a 0.3-mg injection of ranibizumab and 58 of 127 patients (45.7%) who received a 0.5-mg injection gained at least 15 letters of best corrected visual acuity over baseline. In contrast, 16 of 130 patients (12.3%) who received sham injections gained 15 lines or more.

Safety results were consistent with previous ranibizumab phase 3 trials, the release said.

Results of the study are scheduled to be presented in May at the Euretina meeting in London.

Results of the first phase 3 trial of ranibizumab for DME showed a rapid and sustained improvement in visual acuity that began 7 days after treatment and persisted for 24 months.

Both trials are being undertaken to support U.S. Food and Drug Administration approval of DME as an indication for ranibizumab. The anti-VEGF agent is approved by the FDA for wet age-related macular degeneration.