Ranibizumab Reduces Retinopathy Severity in Patients with Diabetic Macular Edema
MAY 02, 2016
In RIDE/RISE, disease severity was graded with the DR Severity Scale by masked evaluators of seven-field fundus photographs, and patients were evenly distributed by disease severity among treatment groups. The analysis of RIDE/RISE by Wykoff and Genentech colleagues found that, among DME patients with moderately severe or severe NPDR, rates of reduction in severity of two steps or more were significantly greater for those who received either dose of Lucentis vs. placebo. These rates were 76% vs. 2%, respectively, after 12 months of treatment, and about 80% vs. 12%, respectively, after 24 months (P <0.0001 for both time points and doses vs. placebo). Also, after 24 months of treatment, 23% in the low-dose group and 28% in the high-dose group had a severity reduction of three steps or more, compared with 1% in the sham-treated group (P<0.0001).
Reduction in disease severity occurred regardless of baseline characteristics, including whether patients had macular nonperfusion shown by fluorescein angiography at baseline. However, after 24 months, the rate of macular nonperfusion doubled in sham-treated patients but remained stable in Lucentis-treated patients.
The analysis also found that very few patients treated with Lucentis had progression to PDR, which was much more common in sham-treated patients. After 12 monthly injections of Lucentis, no patients progressed to PDR at either dose, but 10% of sham-treated patients did. And after 24 monthly injections, no patient in the lower-dose group progressed to PDR, 3% in the higher-dose group did, and nearly 20% in the sham-treated group did.