Judy Kim, MD, professor of ophthalmology at MCW, was the principal investigator for Froedtert & the Medical College of Wisconsin. The results are published online in the New England Journal of Medicine.
The trial was conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), a network dedicated to facilitating multicenter clinical research of diabetic eye disease. DRCR.net is funded by the National Eye Institute, is comprised of more than 350 physicians at approximately140 clinical sites across the country.
DME can occur in people with diabetic retinopathy, a type of diabetic eye disease that results in abnormal blood vessels in the retina. The retina is an inner lining of the eye that acts like a film in a camera. The macula is the area of the retina used when looking straight ahead, for tasks such as reading, driving, and watching television. Macular edema, or swelling, occurs when fluid leaks from abnormal retinal blood vessels and accumulates in the macula, resulting in distortion and reduction of vision. Macular edema can arise during any stage of diabetic retinopathy and is the most common cause of diabetes-related vision loss. About 7.7 million Americans have diabetic retinopathy; of those, about 750,000 have DME.
Each of the 660 participants enrolled in this trial was randomly assigned to receive Eylea (2.0 milligrams/0.05 milliliter), Avastin (1.25 mg/0.05 mL), or Lucentis (0.3 mg/0.05 mL). Participants were evaluated monthly and received the assigned study drug by injection directly into the eye until the DME resolved or stabilized. Additionally, laser treatment was given if DME persisted without continual improvement after six months of injections. Laser treatment alone was the standard treatment for DME until widespread adoption of these drugs a few years ago.
When the study began, participants were 61 years old on average, and had had Type 1 or Type 2 diabetes 17 years on average. Only people with a visual acuity of 20/32 or worse were eligible to participate. (This means that a person with 20/32 vision would have to be 20 feet away from an object that a person with normal vision could see clearly at 32 feet.) At enrollment, about half the participants had 20/32 or 20/40 vision, and the other half had 20/50 or worse vision.
All three drugs evaluated in this clinical trial target a substance called vascular endothelial growth factor (VEGF), which can cause leakage from blood vessels and the growth of new, abnormal blood vessels. Anti-VEGF drugs work for DME by reducing vascular leakage. Based on Medicare allowable charges, the per-injection costs of each drug at the doses used in this study were about $1960 for Eylea, about $70 for Avastin, and about $1200 for Lucentis. During the year-long study, participants on Avastin and Lucentis received, on average, 10 injections, versus nine for those on Eylea.
One year after starting treatment, vision had improved substantially for the majority of trial participants. When visual acuity was 20/32 or 20/40 at the start of the trial, vision improved on average almost two lines on an eye chart in all three treatment groups. In contrast, for participants whose visual acuity was 20/50 or worse at the start of the trial, Eylea improved vision on average almost four lines, Avastin improved vision on average almost 2.5 lines, and Lucentis improved vision on average almost three lines.
“This comparative study is a landmark study in the treatment of DME. We had known the benefit of anti-VEGF agents from previous clinical trials that we had participated in but did not know which drug was better, if any, and for which patient. The results of this trial will help doctors and patients make informed decisions when choosing treatments for DME,” said Dr. Kim. “I am grateful to the patients who volunteered and participated in this and other clinical trials and my colleagues, research coordinators, and photographers who assisted in this study at the Eye Institute.”
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