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Marco A Zarbin, Ivo Stoilov, Na Lu; Long-term diabetic retinopathy and macular edema outcomes with anti-VEGF treatments in randomized controlled clinical studies. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2083.
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To examine the similarities and potential differences in long-term vision outcomes (≥2 years) across trials of ranibizumab (RBZ), aflibercept (AFL), and bevacizumab (BVZ) for the treatment of diabetic retinopathy (DR) and diabetic macular edema (DME).
Study designs, primary endpoints, inclusion/exclusion criteria, baseline (BL) characteristics, long-term vision and DR outcomes, and injection frequencies were compared for the Diabetic Retinopathy Clinical Research Network Protocol-I, -T, and -S, RISE/RIDE, VIVID/VISTA and BOLT. DR severity was evaluated on fundus photographs (FP) graded on the Early Treatment Diabetic Retinopathy Study DR Severity Scale (DRSS).
BL vision varied across the trials. Protocol-I, -T and S enrolled patients with BCVA up to 20/32 (Snellen equivalent), whereas RIDE/RISE and VIVID/VISTA restricted BL BCVA to 20/40 or worse. At BL, 24−34% of eyes in Protocol-I and RIDE/RISE were graded to have mild/moderate proliferative DR (PDR; DRSS 60−65) vs. only 1−7% in VIVID/VISTA and BOLT. The majority of patients in Protocol S had moderate- and high-risk BL PDR. Mean change in BCVA from BL and percentage of patients with 2-step improvement on the DRSS are shown in Figures 1 and 2, respectively. Only 1-year data were available from Protocol T. In most trials, baseline vision correlated with vision gains suggesting a ceiling effect. Injection frequencies (less than monthly) were comparable for the 3 anti-VEGFs despite different doses and molecular structures.
This cross-trial comparison suggests that intensive early anti-VEGF treatment can resolve DME and significantly improve vision. These outcomes were maintained with less than monthly treatment. In Protocol S, RBZ was effective in the management of moderate- and high-risk PDR. Although findings should be interpreted with caution given the limitations of cross-trial comparisons, there was no additional benefit of aflibercept 2 mg over ranibizumab 0.3 mg with respect to treatment burden or DR improvement.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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