The Juvenile Diabetes Research Foundation is currently enrolling patients to participate in the second phase of the Ranibizumab for Edema of the Macula in Diabetes (READ-2) study.
Supported by Genentech Inc. and the nonprofit U.S.-based JDRF, the study is designed to test the long-term safety and effectiveness of intraocular injections of ranibizumab in patients with diabetic macular edema. In this phase II study, researchers also would like to compare the results of ranibizumab injection with laser photocoagulation, the standard treatment of diabetic macular edema, according to a statement issued by the foundation.
The researchers want to enroll 126 participants in this multicenter clinical trial, age 18 and older with macular edema as a result of type 1 or type 2 diabetes. The study will consist of a 2-week screening period, a 6-month treatment period, and an 18-month follow-up and treatment period.
In a phase I study, Dr. Quan Dong Nguyen, Dr. Peter A. Campochiaro, and their colleagues found that ranibizumab was successful in improving visual acuity at 7 months. There were no adverse events related to ranibizumab, although some patients did experience redness on the surface of the eye at the injection site that lasted up to 72 hours. The cause of the redness was more likely caused by the injection and not by the drug itself, the investigators said.
Genentech manufactures ranibizumab, which is used to treat patients with wet age-related macular degeneration. The drug blocks a growth factor thought to be involved in the formation of abnormal blood vessels that cause the loss of vision in diabetic macular edema patients.
Ranibizumab was approved by the Food and Drug Administration in June 2006.
The phase I trial, which began in December 2006, took place at the Wilmer Eye Institute at Johns Hopkins University, Baltimore. Phase II will take place at the Phoenix-based Retinal Consultants of Arizona and other sites. The expected completion date of the phase II study is January 2009.
For additional study and participation information, visit www.clinicaltrials.gov/ct/show/NCT00407381?order=14