Phase III ranibizumab study demonstrates rapid vision improvement for DME

March 21, 2011

Lucentis administered to diabetic macular oedema (DME) patients demonstrated vast vision improvement, according to a Phase III study conducted by Genentech.

Lucentis administered to diabetic macular oedema (DME) patients demonstrated vast vision improvement, according to a Phase III study conducted by Genentech.

The data recorded from the 24-month RISE study revealed 44.8% of patients who received 0.3 mg Lucentis and 39.2% of patients who received 0.5 mg were capable of reading 15 or more letters on the eye chart, compared to 18.1% of placebo patients. The changes in vision were measured by best-corrected visual acuity (BCVA) based on a standardized eye chart.

The mean gain in BCVA of patients who received 0.3 mg and 0.5 mg Lucentis was 12.5 and 11.9 letters from baseline, respectively. The result was 2.6 letters for the placebo-controlled group. The mean reduction in central foveal thickness was 250.6 microns for the group receiving 0.3 mg Lucentis and 253.1 microns for the group receiving 0.5 mg. The sham injection group had a mean decrease of 133.6 microns.

Dr Dennis M. Marcus, Southeast Retina Center, Augusta, Georgia, USA, said: "There are no FDA-approved medicines to treat DME and these new data add to evidence showing that Lucentis can help improve vision soon after initiation of treatment. In the case of the RISE study, the significant improvements on day seven were maintained for two years."