A Phase II clinical trial for a promising treatment for diabetic eye disease has begun enrolling participants.
The Juvenile Diabetes Research Foundation, a leader in setting the agenda for diabetes research worldwide, and The Wilmer Eye Institute of Johns Hopkins University announced today that the READ 3 Study (Ranibizumab for Edema of the mAcula in Diabetes - Protocol 3 with High Dose Study) will evaluate the safety and efficacy of a injections of an antibody treatment in people with diabetic macular edema (DME).
DME is a major complication of diabetes and a leading cause of blindness in adults. In DME, leakage of fluid from the blood vessels in the eye causes the retina to swell, resulting in blurring and visual loss.
The READ-3 Study is a collaboration between JDRF and Johns Hopkins University, with funding support from Genentech, Inc. (a member of the Roche group), and involves 14 clinical centers across the U.S. that will collectively enroll some 100 patients. The Wilmer Eye Institute of Johns Hopkins University will serve as the Coordinating Center for the participating clinical sites, and the Retinal Imaging Research and Reading Center at Wilmer will serve as the Reading Center for the READ 3 Study.
READ-3 is a Phase 2 study designed to compare two different doses of the antibody treatment to determine if a higher dose is more effective in improving vision and decreasing retinal thickness; it will also determine if higher doses can reduce the frequency of subsequent treatments for DME.
After screening to confirm diabetic macular edema (and no other factors that would exclude someone from the study), the participants will receive either 1 or 2 doses of ranibizumab for six months, followed by a six-month follow up-period with the option for additional treatments. Participants must be at least 18 years of age and have macular edema as the result of diabetes. For additional study information and participation, please visit www.READ3.net or JDRF's Clinical Trials Connection at www.trials.jdrf.org.
Without treatment, diabetic macular edema can cause vision impairment, blurriness, or blindness. Therapies to free people from the devastating health burden of complications that can accompany diabetes, including diseases of the eye, nerves, and kidneys, are an important focus of JDRF research; in the last fiscal year, the foundation invested more than $22 million in research involving Complications Therapies.