Impact of Intravitreal Aflibercept (IVT-AFL) on Diabetic Retinopathy in the VIVID-DME and VISTA-DME Studies
Abstract
Purpose
Post-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.
Methods
Patients (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.
Results
The 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%).
Conclusions
A 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.
