Session Title: Vascular Diseases and Diabetic Retinopathy II
Session Date/Time: Friday 18/09/2015 | 16:30-18:00
Paper Time: 17:10
First Author: : P.Mitchell AUSTRALIA
Co Author(s): : M. Larsen J. Korobelnik K. Lorenz C. Lu T. Katz C. Metzig
PURPOSE:The VIVID-DME and VISTA-DME trials evaluated intravitreal aflibercept (IVT-AFL) vs. laser for diabetic macular edema (DME). The current exploratory analyses assessed additional changes in the diabetic retinopathy severity scale (DRSS) score, as well as the development of proliferative diabetic retinopathy (PDR), up to week 100.
VIVID-DME and VISTA-DME were phase 3, randomized, double-masked, active-controlled, 148-week trials. VIVID-DME took place at 73 sites in Europe, Japan, and Australia, and VISTA-DME was conducted at 54 sites in the United States.
Patients were randomized to IVT-AFL 2mg every 4 weeks + sham laser (2q4), IVT-AFL 2mg every 8 weeks (after 5 initial monthly doses) + sham laser (2q8), or laser + sham injections. The primary endpoint was mean change from baseline in BCVA at week 52. The proportion of patients with a ≥2-step improvement from baseline on the DRSS was a secondary end point at week 100. Patients were considered to have developed PDR if baseline DRSS score was <61 and there was at least 1 post-baseline DRSS score ≥61. As the DRSS was assessed only at baseline, week 24, week 52, week 76, and week 100, use of panretinal photocoagulation (PRP) was also evaluated as a proxy for PDR development. Results are presented for pooled IVT-AFL 2q4 and 2q8 treatment arms in each study.
The proportion of patients receiving IVT-AFL vs. laser with a ≥2-step improvement in DRSS at week 100 was 31.0% vs. 8.2% (VIVID-DME) and 37.0% vs. 15.6% (VISTA-DME); the proportion with a ≥3-step improvement was 4.8% vs. 0.0% (VIVID-DME) and 22.8% vs. 5.7% (VISTA-DME). The proportion of patients receiving IVT-AFL vs. laser who developed PDR through week 100 was 1.8% vs. 5.3% (VIVID-DME) and 2.9% vs. 13.0% (VISTA-DME); when data were integrated across the two trials, the respective proportions were 2.4% vs. 9.4% (P≤0.0001). The proportion of patients receiving IVT-AFL vs. laser who received PRP through week 100 was 1.8% vs. 4.5% (VIVID-DME) and 1.3% vs. 5.2% (VISTA-DME); when data were integrated, the respective proportions were 1.6% vs. 4.9% (P=0.0064). Not all cases of PDR led to PRP and not all cases of PRP were captured as PDR at the DRSS reading time points, resulting in different proportions in the two analyses. The most common ocular serious adverse event in IVT-AFL-treated patients was cataract (VIVID-DME, 2.2%, VISTA-DME, 1.3%).
In the VIVID-DME and VISTA-DME studies, a greater proportion of patients treated with IVT-AFL experienced ≥2- and ≥3–step improvements in DRSS scores at week 100 compared with laser-treated patients. Conversely, a smaller proportion of IVT-AFL-treated patients in both studies developed PDR and/or received PRP over the 100 weeks compared with laser. These findings through 100 weeks of the VIVID-DME and VISTA-DME studies demonstrate benefits of IVT-AFL over laser in the treatment of the underlying eye disease in patients with diabetes. These data further support the concept that IVT-AFL has a beneficial impact not only on DME, but also on the underlying diabetic retinopathy.