In 2011, Lucentis became the first breakthrough treatment in more than 20 years for people with diabetic macular edema (DME), a leading cause of blindness among the working-age population (ages 20 to 74). Unfortunately, it does not work for everyone with the disease. Now, JDRF has teamed up with Vancouver-based company iCo Therapeutics to support the development of a new drug—one that, if successful, can work alone or in tandem with Lucentis to provide another therapeutic option to people with type 1 or type 2 diabetes suffering from the condition.
The Phase II trial called iDEAL—one of the largest studies of its kind—will enroll as many as 208 people with type 1 or type 2 diabetes and DME at up to 30 clinical sites across the United States to see if the drug iCo-007 will improve their sharpness of vision within eight months as tested with a standard eye chart. The multicenter effort, led by Quan Dong Nguyen, M.D., associate professor of ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine, is currently recruiting volunteers. All study participants will be followed for 12 months.
“The purpose of this trial is to see if iCo007, alone or in combination with Lucentis, is effective in treating diabetic macular edema, which affects 14 percent of people with type 1 diabetes,” says Helen Nickerson, Ph.D., JDRF’s senior scientific program manager of complications. “This collaboration with iCo Therapeutics is exciting because we need additional tools to prevent vision loss for DME and we need to learn how to best use these tools in combination with existing therapies.”
Diabetic macular edema is a complication of diabetic retinopathy, which is caused by either changes of blood vessels in the retina or the growth of new ones that are tiny and fragile. These damaged blood vessels may leak fluid, or blood, and create scar tissue that blurs and distorts vision. In the case of DME, fluid collects in the macula, the central portion of the retina. If left untreated, the swelling of the macula can lead to severe vision loss and even blindness.
Lucentis, or ranibizumab injection, has been shown to stunt or prevent the growth of these tiny and fragile blood vessels in the macula by blocking the effects of a protein known as vascular endothelial growth factor, or VEGF. iCo-007 may have the potential to inhibit the growth of these new blood vessels, but rather than target VEGF alone, iCo-007 works by tamping down the production of a protein called c-Raf kinase, which interacts with VEGF and other growth factors that are important in the etiology of diabetic retinopathy. VEGF is best known for its role in cancer, where it promotes the growth of tumors.
“Diabetic macular edema is both devastating and prevalent, and yet today’s treatments are insufficient for everyone with this complication,” says Aaron Kowalski, Ph.D., assistant vice president of treat therapies for JDRF. “As we investigate a novel pathway to inhibit the pathogenesis of this disease, we are collecting useful data about iCo-007 in the process that will enhance our understanding of diabetic macular edema, and hopefully build upon currently available resources used to manage this disease.”