Impact of Intravitreal Aflibercept (IVT‐AFL) on Diabetic Retinopathy in the VIVID‐DME and VISTA‐DME Studies

Abstract

PurposePost‐hoc analysis to assess changes in the diabetic retinopathy severity scale (DRSS) score and the development of proliferative diabetic retinopathy (PDR) in VIVID‐DME and VISTA‐DME.MethodsPatients (pts) were randomized to IVT‐AFL 2 mg every 4 weeks + sham laser (2q4), IVT‐AFL 2 mg every 8 weeks (after 5 initial monthly doses) + sham laser (2q8), or laser + sham injections. Primary efficacy endpoint was mean change from baseline (BL) in visual acuity at week (W)52; the proportion of pts with a ≥ 2‐step improvement from BL on the DRSS was a secondary endpoint at W100. Pts were considered to have developed PDR if BL DRSS score was <61 and there was ≥1 post‐baseline DRSS score ≥61. Results are presented for pooled IVT‐AFL 2q4 and 2q8 treatment arms.ResultsThe proportion of pts receiving IVT‐AFL vs. laser with a ≥ 2‐step improvement in DRSS at W100 was 31.0% vs. 8.2% (VIVID‐DME) and 37.0% vs. 15.6% (VISTA‐DME). The proportion of pts receiving IVT‐AFL vs. laser who developed PDR through W100 was 1.8% vs. 5.3% (VIVID‐DME) and 2.6% vs. 12.3% (VISTA‐DME); when data were integrated across the two trials, the respective proportions were 2.4% vs. 9.4% (nominal P ≤ 0.0001). The most common ocular serious AE in IVT‐AFL‐treated pts was cataract (VIVID‐DME, 2.2%, VISTA‐DME, 1.3%).ConclusionsA greater proportion of pts treated with IVT‐AFL experienced ≥step improvements in DRSS scores at W100 compared with laser‐treated pts. A smaller proportion of IVT‐AFL‐treated pts in both studies developed PDR compared with laser. These findings demonstrate the beneficial impact of IVT‐AFL not only on DME, but also on the underlying diabetic retinopathy.