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A post-hoc analysis of a randomized clinical trial comparing 3 anti-vascular endothelial growth factor (VEGF) agents, found that intravitreous aflibercept was associated with the greatest improvement in visual acuity (VA) over 2 years, for patients with diabetic macular edema (DME).
The trial occurred from August 22, 2012, to September 23, 2015, and involved a total of 660 participants (mean age, 61 years; 47% female) with diabetic macular edema (DME). Participants were randomized to either intravitreous aflibercept (2mg), bevacizumab (1.25mg), or ranibizumab (0.3mg), administered up to monthly based on a structured retreatment regimen.
Results showed that for eyes with a baseline VA of 20/50 or worse, the aflibercept treated group had a greater VA improvement than bevacizumab and ranibizumab after 1 year, but was superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P <.001) or ranibizumab (+13.6 [8.5]; 95% CI, +0.7 to +6.0; P=.009).
When groups were stratified by baseline VA, anti-VEGF agent, and whether focal/grid laser treatment was performed for DME, the only participants to have a substantial reduction in central subfield thickness were those receiving bevacizumab and laser treatment (SD, -55 [108] µm; 95% CI, −82 to −28 µm; P<.001).
The authors advise caution in assessing their results, highlighting how post-hoc analyses have a distinct potential for bias. However, their study did reveal results which suggest that the greatest VA improvements over 2 years were associated with aflibercept.
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