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    Insights from anti-VEGF pivotal DME trials

    Dr. ZarbinAnalyses of data collected in the RISE/RIDE and VIVID/VISTA clinical trials provide important messages about the efficacy and safety of ranibizumab (Lucentis, Genentech) and aflibercept (Eylea, Regeneron) for treatment of diabetic macular edema (DME).

    “We learned from these pivotal trials that the anti-VEGF agents are disease-modifying in that they do not just treat DME,” said Marco Zarbin, MD, PhD, professor and chairman, Department of Ophthalmology & Visual Science, Rutgers-New Jersey Medical School, Newark, NJ. “They also reduce severity of diabetic retinopathy in patients with DME.”

    Data also show that visual outcomes are better with anti-VEGF treatment than with conventional focal macular laser photocoagulation, Dr. Zarbin added. Visual outcome seems to be adversely affected if anti-VEGF treatment is delayed for one to two years, even though the edema resolves after delayed initiation of anti-VEGF therapy.

    “In addition, analyses of adverse event data demonstrate that systemic risks of intravitreal anti-VEGF injections are real, particularly for patients with high exposure receiving ongoing monthly treatment,” he said.


    Disease-modifying benefit

    Data on diabetic retinopathy severity graded using the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (DRSS) were collected in the ranibizumab and aflibercept DME trials (RISE/RIDE and VIVID/VISTA, respectively). Improvement in diabetic retinopathy was analyzed using the metric of a ≥2-step improvement in the DRSS.

    2-Step Improvement in Diabetic Retinopathy Severity Score in Year-1. Courtesy of Marco Zarbin, MD, PhD

    In RIDE/RISE, about one third of patients receiving ranibizumab 0.3 mg achieved this endpoint after 1 year of treatment, and this percentage was significantly greater than in the sham-treated control group. The proportion of patients treated with ranibizumab 0.3 mg, who achieved a ≥2-step improvement in the DRSS, increased after 2 years of treatment.

    Results with aflibercept in VIVID/VISTA were similar with respect to percentage of patients benefiting, the increase with time, and the superiority compared with controls, Dr. Zarbin said.

    The sooner, the better


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