In a news conference yesterday, researchers announced findings from a government study comparing treatments for swelling of the retina caused by leaking blood vessels in the eye.
Nearly 50% of patients given eye injections of the drug Lucentis along with laser treatments showed improvement in vision after a year of treatment, compared to just over a fourth of patients treated with laser alone.
For several decades, laser has been the standard treatment for diabetic macular edema, or DME, in which fluid builds up near the center of the retina.
“For the first time in 25 years we have definitive proof that a new treatment can lead to better results for the eye health of people with diabetes,” said Neil M. Bressler, MD, who oversaw the study as chairman of the Diabetic Retinopathy Clinical Research Network.
Lucentis is a genetically engineered drug derived from the cancer drug Avastin, which was the first targeted biologic treatment approved by the FDA.
The newer biologic was approved in June 2006 for the treatment of age-related macular degeneration, which is the leading cause of blindness in the elderly.
Bressler said the clear superiority of Lucentis with laser over laser alone in patients with diabetic macular edema should have an immediate impact on clinical practice, even though the biologic treatment is not approved for this indication.
“We expect the results of this study to have a major impact on how ophthalmologists treat macular edema in people with diabetes,” he says.
The study included 691 diabetic patients with macular edema in one or both eyes.
The patients received either standard laser treatment alone, Lucentis plus laser treatments in different dosing schedules, or the injectable steroid drug Trivaris with standard laser therapy.
Lucentis injections were limited to once a month, but most patients ended up having no more than eight or nine injections over the course of a year.