The Juvenile Diabetes Research Foundation, the world?s largest charitable funder of type 1 diabetes research, announced that the Ranibizumab for Edema of the mAcula in Diabetes Phase 2 Study (READ 2) is now enrolling patients.
The READ 2 Study will test the long-term safety and effectiveness of intraocular injections of ranibizumab in patients with diabetic macular edema (DME), a condition characterized by swelling of the retina due to leaking of fluid from blood vessels within the macula. DME is the leading cause of vision loss among working-age Americans.
The READ2 study is supported by Genentech and JDRF. The Phoenix-based Retinal Consultants of Arizona will serve as a clinical center for the trial.
This Phase 2 clinical trial builds on the results of a phase 1 trial (which was supported by an Innovative Grant Award from JDRF), which showed the ability of ranibizumab to improve visual acuity in patients with diabetic macular edema. Visual acuity was assessed using a reading chart, and median and mean visual acuity improved by 11 and 12.3 letters respectively at 7 months. This corresponds to the ability to read two additional lines on a reading chart. In the phase 1 study, there were no adverse events that were judged by the investigators to be related to the drug. Some patients experienced redness on the surface of the eye at the site of injection that lasted up to 72 hours. The redness was thought to be due to the injection itself, however, and not the drug.
The READ 2 study will look specifically for additional dosing and safety information, as well as combination therapy of ranibizumab and laser photocoagulation (which has been the standard therapy for DME). The study consists of a two-week screening period, a six-month active treatment period, and an 18-month follow-up and treatment period.