JDRF News Blog: JDRF Clinical Trial Enrolling Newly Diagnosed Patients

Update: Positive results reported in Phase III study on promising drug for diabetic eye disease

February 23, 2011

Genentech, Inc. (a member of the Roche Group) recently announced that its Phase III study RISE, evaluating the drug Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. Results showed that a significantly higher percentage of patients receiving monthly Lucentis had an improvement in vision on the eye chart at 24 months, compared to patients in a control group who received a placebo injection.

DME is a serious complication of diabetes that involves swelling of the retina, which can lead to blurred vision and blindness, and affects up to 10 percent of people with diabetes. Although Lucentis was recently approved to treat DME in Europe, no drugs to treat DME are currently approved by the U.S. Food and Drug Administration (FDA). 

Genentech is simultaneously conducting a second Phase III study, known as RIDE.  RISE and RIDE are two identical, parallel studies designed to support application to FDA for Lucentis for DME.