No additional visual benefit seen with nesvacumab-aflibercept combination in DME
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In patients with diabetic macular edema, combination treatment with nesvacumab and aflibercept had no visual benefit over aflibercept alone, according to data from the phase 2 RUBY study published in Retina.
Some patients with DME do not completely respond to standard treatment with aflibercept or ranibizumab. Meanwhile, patients with diabetes have demonstrated increased intravitreal and plasmas levels of angiopoietin-2 (Ang2), making nesvacumab, an Ang2 inhibitor, a potential treatment for DME.
In the study, 302 eyes were randomly assigned 1:2:3 to nesvacumab 3 mg plus aflibercept 2 mg, nesvacumab 6 mg plus aflibercept 2 mg, or aflibercept 2 mg alone at baseline, week 4 and week 8.
Treatment in the 3 mg combination group continued every 8 weeks from week 16 to week 32. Starting at week 16 or week 20, patients in the 6 mg combination group were re-randomized (1:1) to the same treatment every 8 weeks or every 12 weeks until week 32. Starting at week 16 or week 20, the aflibercept group was re-randomized (1:1:1) to aflibercept every 8 weeks, aflibercept every 12 weeks or the 6 mg combination every 8 weeks through 32 weeks.
At week 12, best corrected visual acuity gains were 6.8 letters in the 3 mg combination group, 8.5 letters in the 6 mg combination group and 8.8 letters in the aflibercept group, with similar changes observed at 36 weeks.
Reductions in central subfield retinal thickness at week 36 were –210.4 µm for the 3 mg combination group, –223.4 µm for the 6 mg combination every 8 weeks group, –193.7 µm for the 6 mg combination every 12 weeks group and –61.9 µm for the aflibercept group.
At week 12, 13.3% of the 3 mg combination group and 21.3% of the 6 mg combination group had two or more step improvement on the Diabetic Retinopathy Severity Scale vs. 15.2% of the aflibercept group, with greater proportions observed in all groups at week 36. In addition, 59.6% of the 3 mg combination group and 66.3% of the 6 mg combination group had complete foveal center fluid resolution vs. 53.7% of the aflibercept group at week 12.
“The indication of positive anatomic effects may warrant further investigation of the role of anti-Ang2 agents in combination with anti-VEGF therapy,” David M. Brown, MD, and colleagues wrote.
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