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Phase 3 trial evidence supports use of aflibercept in DME
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BOSTON — Among “lessons learned” from the VIVID and VISTA trials is that aflibercept is an effective treatment for patients with center-involved diabetic macular edema, according to one presenter at Macula 2015.
“The totality of the evidence suggests that aflibercept is a very effective and safe treatment for our patients with DME,” Diana V. Do, MD, said at Macula 2015, adding that the diabetic retinopathy severity score improves with use of the drug as well.
In the phase 3 VIVID and VISTA trials, which looked at visual acuity gains in patients with DME treated with laser or Eylea (aflibercept, Regeneron), the treatment effects in subgroups of eyes previously treated with anti-VEGF before enrollment were similar to those in patients who were anti-VEGF-naïve before enrollment, she said.
Furthermore, treatment effects were not influenced by baseline visual acuity; however, the average maximal visual gains were influenced by baseline vision.
“If eyes started off with very good vision at baseline, 20/50 or better, there was a ceiling effect, and the average maximal gain was limited, even in aflibercept-treated subjects,” Do said.
In laser-treated eyes, increasing HbA1c levels correlated with decreased visual and anatomic outcomes, whereas in aflibercept-treated eyes, the effect of baseline demographic characteristics, such as systemic cardiovascular disease and increasing HbA1c level, was not associated with visual acuity outcomes, according to the presentation.
Finally, aflibercept had no safety signals in the VIVID and VISTA trials, Do said.
Disclosure: Do receives research funding from Allergan, Genentech and Regeneron and is a consultant to Allergan, Bayer, Genentech and Regeneron .