The American Diabetes Association 71st Scientific Sessions:

Drug for Diabetic Macular Edema Shows ‘Huge’ Improvement Over Standard Care

Intraocular injections of the anti-vascular endothelial growth factor (anti-VEGF) drug ranibizumab (RBZ) produced statistically significant gains in visual acuity over sham treatment for patients with diabetic macular edema (DME), according to 2 large trials presented at the 2011 American Diabetes Association meeting.

The results of the prospective, randomized, double-blind trials will “change the entire paradigm of how to treat diabetic patients’ macular edema,” said the first author and presenter of the studies, David S. Boyer, MD, clinical professor of ophthalmology at the University of Southern California’s Keck School of Medicine. “Many patients who would not otherwise be able to drive will now meet the legal standard. It’s a huge improvement over existing treatments.”

Dr. Boyer presented results from two 24-month phase 3 trials involving DME patients with best corrected visual acuity of 20/40 to 20/320. Patients in both trials were eligible for laser therapy after 3 months, and 72% of those receiving sham therapy received it, compared to 33% of patients given RBZ.

The RISE trial involved 127 DME patients given sham therapy, 125 given 0.3 mg of RBZ, and 125 given 0.5 mg of RBZ. The RIDE trial involved 130 patients given sham, 125 given 0.3 mg of RBZ, and 127 given 0.5 mg of RBZ.

The primary outcome was the proportion of patients gaining at least 15 standardized eye-chart letters at month 24. In the RISE trial, 18.1% of patients given sham treatment achieved that outcome, compared to 44.8% of those given 0.3 mg of RBZ and 39.2% of those given 0.5 mg (p<0.05) of RBZ. In the RIDE trial, 12.3% of patients given sham achieved the primary outcome, compared to 33.6% of those given 0.3 mg of RBZ and 45.7% of those given 0.5 mg (p<0.05) of RBZ. No significant differences were seen in adverse outcomes.

While approved for other disorders, the drug is not yet approved for DME. “Hopefully with this study, we’ll see it approved,” said Dr. Boyer. “This is a potential new standard of care for DME. The take-home message is we have new treatments. Patients need to be referred in for their eye care professional early in the course of the disease.”

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