Clinical Trial For Diabetic Macular Edema

Main Category: Diabetes
Article Date: 03 Apr 2007 - 7:00 PDT

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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.

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Participants must be at least 18 years of age, and have macular edema as a result of type 1 or type 2 diabetes.

For additional study information and participation, please visit http://www.clinicaltrials.gov/ct/show/NCT00407381?order=14

About Ranibizumab

Ranibizumab is designed to block a natural protein in the body 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 Phase 1 clinical trial, Dr. Quan Dong Nguyen, Dr. Peter Campochiaro, and colleagues at the Wilmer Eye Institute of Johns Hopkins University treated 10 patients with chronic diabetic macular edema with ranibizumab. The trial participants received injections of the drug, with follow-up injections at one, two, four, and six months. The outcome revealed that ranibizumab significantly reduced macular swelling in all patients and improved visual acuity. The phase 1 clinical trial for DME followed the investigative work by Genentech, Inc., which manufactures ranibizumab and had reported encouraging results from two large Phase 3 trials testing the drug for a similar condition called wet age-related macular degeneration. Ranibizumab was approved by the U.S. Food and Drug Administration for the treatment of patients with wet age related macular degeneration in June 2006.

About JDRF

JDRF was founded in 1970 by the parents of children with type 1 diabetes - a disease that strikes children, adolescents, and adults suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications. Since inception, JDRF has provided more than $1 billion to diabetes research worldwide. More than 80 percent of JDRF's expenditures directly support research and research-related education. JDRF's mission is constant: to find a cure for diabetes and its complications through the support of research. For more information about JDRF please visit http://www.jdrf.org/

Contact: Eileen Brangan
Juvenile Diabetes Research Foundation International

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