NEW YORK, March 26, 2010 - 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.
About Ranibizumab and the READ Studies
The READ-3 Trial is the third READ study to test the effectiveness of ranibizumab as a treatment of diabetic eye disease.
Ranibizumab is an antibody designed to block a protein called vascular endothelial growth factor (VEGF), which is produced in excessive amounts in people with diabetes. VEGF causes leakage in the small blood vessels of the eye that can lead to vision loss and, eventually, blindness. In the READ-1 study, Dr. Quan Dong Nguyen, Dr. Peter Campochiaro, and colleagues at the Wilmer Eye Institute of Johns Hopkins University (under the JDRF collaboration) treated 10 patients who suffered from chronic diabetic macular edema. The trial participants received injections of the drug, with follow-up injections at one, two, four, and six months. The injections were well-tolerated and the results showed that ranibizumab significantly reduced macular swelling and improved vision.
In the READ-2 Study (a multi-center national trial also supported by JDRF) designed by Dr. Nguyen, Dr. Campochiaro, and Dr. Diana Do of the Wilmer Eye Institute, researchers from 14 clinical centers throughout the U.S. enrolled 126 patients to compared the effectiveness of ranibizumab versus conventional treatment - laser photocoagulation therapy. The study results showed a significantly greater improvement in vision in patients treated with ranibizumab than those receiving laser surgery or a combination of both.
Dr. Nguyen, Dr. Campochiaro, Dr. Do, and 14 other clinician scientists from clinical centers in California, Florida, Hawaii, Illinois, Kansas, Maryland, Pennsylvania, South Dakota, and Texas designed the READ-3 Study.
Ranibizumab was approved by the U.S. Food and Drug Administration for the treatment of patients with a type of age-related macular degeneration in June 2006. In addition to the READ studies, Genentech is conducting two parallel, phase 3 trials studying the safety and efficacy of different doses of ranibizumab to treat diabetic macular edema.
JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder and advocate of type 1 research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is a disease which strikes children and adults suddenly and requires multiple injections of insulin daily or a continuous infusion of insulin through a pump. Insulin, however, is not a cure for diabetes, nor does it prevent its eventual and devastating complications which may include kidney failure, blindness, heart disease, stroke, and amputation. Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes research, including more than $100 million last year.
For more information, please visit www.jdrf.org