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RISE, RIDE: Ranibizumab bested sham injection in diabetic macular edema

Issue: August 2011

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ADA 71st Scientific Sessions

SAN DIEGO — Treatment with ranibizumab was associated with statistically significant improvements in best corrected visual acuity and retinal thickness, according to data from the RISE and RIDE trials.

In both studies, more patients treated with ranibizumab had visual gains of 15 letters or more, with less significant visual acuity loss and fewer complications of diabetic retinopathy.

“There was a rapid and sustained improvement in both vision and retinal anatomy, and there was reduced progression — actually an improvement in — diabetic retinopathy,” David S. Boyer, MD, of the Retina Vitreous Associates Medical Group in Los Angeles, said during the late-breaking abstract session here.

RISE and RIDE, prospective, double-masked, phase 3 trials, compared the use of monthly ranibizumab (66% of patients) to sham injections (33% of patients) in patients with vision loss and diabetic macular edema. All patients were eligible for rescue macular laser starting during the third month. Visual gain of 15 letters or more at 24 months was the primary endpoint.

In the RISE study, 18.1% of patients assigned to sham achieved >15 letters vs. patients in the ranibizumab groups: 44.8% in the 0.3 mg group and 39.2% in the 0.5 mg group (P<.05). Patients in the ranibizumab group achieved a higher mean of letters for best corrected visual acuity, compared with the sham group: 12.5 letters gained in the 0.3 mg group and 11.9 letters gained in the 0.5 mg group vs. 2.6 letters in the sham group (P<.05). Adverse events, including deaths of vascular and unknown cause, nonfatal MI and nonfatal stroke, were 4.9% in the sham group, 2.4% in the 0.3 mg group and 8.7% in the 0.5 mg group.

Results were similar in the RIDE group: 130 patients were assigned to sham injection, 125 to 0.3 mg ranibizumab and 127 to 0.5 mg ranibizumab. The percentage of patients gaining >15 letters was significantly higher in the ranibizumab groups compared with sham: 33.6% in the 0.3 mg group and 45.7% in the 0.5 mg group vs. 12.3% in the sham group. Mean letters gained for best corrected visual acuity were 2.3 in the sham group, 10.9 in the 0.3 mg group and 12.0 in the 0.5 mg group. Adverse events were similar among the three treatment arms: 5.5% for sham, 8.8% for 0.3 mg and 5.6% for 0.5 mg.

“This is a potential new standard for the treatment of patients with diabetic macular edema and underscores the need for prompt referral to the ophthalmologist for treatment,” Boyer said.

For more information:

• Boyer DS. 132-LBOR. Presented at: American Diabetes Association’s 71st Scientific Sessions; June 24-28, 2011; San Diego, Calif.

Disclosure: Dr. Boyer is a consultant for ALCON Laboratories, Allergan, Genentech, Novartis Pharmaceuticals Corporation, Pfizer and Regeneron Pharmaceuticals. He is in the speaker’s bureau for ALCON laboratories; Allergan and Genentech.

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