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Paul Mitchell, Mark C Gillies, Michael Larsen, Giovanni Staurenghi, Frank G Holz, Todd A Katz, Chengxing Lu, Christiane Ahlers, Carola Metzig, Oliver Zeitz, VIVID-DME and VISTA-DME study investigators; Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema: Evaluating the Impact on Diabetic Retinopathy. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3146.
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To evaluate the impact of intravitreal aflibercept injection (IAI) on diabetic retinopathy severity in patients with diabetic macular edema (DME).
The VIVID-DME and VISTA-DME trials evaluated IAI vs. laser for DME. Patients were randomized to IAI 2mg every 4 weeks + sham laser, IAI 2mg every 8 weeks (after 5 initial monthly doses) + sham laser, or laser + sham injections. The primary endpoint was change from baseline (BL) in BCVA at week 52 (W52). The proportion of patients with a ≥2-step improvement from BL on the diabetic retinopathy severity scale (DRSS) was a secondary end point. The current exploratory analyses assessed additional changes in the DRSS, as well as the development of proliferative diabetic retinopathy (PDR) up to W52. Patients were considered to have developed PDR if BL DRSS score was <61 and there was at least 1 post-BL DRSS score ≥61. As the DRSS was assessed only at BL, W24 and W52, use of panretinal photocoagulation (PRP) was also evaluated as a proxy for PDR development. Pooled IAI data are reported.
The proportion of patients receiving IAI vs. laser with a ≥2-step improvement in DRSS at W52 was 30.5% vs. 7.5% (VIVID-DME) and 31.5% vs. 14.3% (VISTA-DME); the proportion with a ≥3-step improvement at W52 was 3.0% vs. 0.0% (VIVID-DME) and 14.7% vs. 5.2% (VISTA-DME). The proportion of patients receiving IAI vs. laser who developed PDR through W52 was 0.7% vs. 5.3% (VIVID-DME) and 2.6% vs. 9.1% (VISTA-DME); when the data were integrated, the respective proportions were 1.7% vs. 7.3% (P=0.0001). The proportion of patients receiving IAI vs. laser who received PRP through W52 was 1.1% vs. 3.0% (VIVID-DME) and 0.7% vs. 3.9% (VISTA-DME); when the data were integrated, the respective proportions were 0.9% vs. 3.5% (P=0.0099). It is possible that mild cases of PDR may not have led to PRP use; hence, the difference proportions in the 2 analyses. Overall, the most common ocular serious AEs in IAI-treated patients were cataract (VIVID-DME, 0.7%) and vitreous hemorrhage (VISTA-DME, 0.7%).
These findings from the initial 52 weeks of the VIVID-DME and VISTA-DME studies demonstrate benefits of IAI over laser in terms of diabetic retinopathy outcomes. These data further support the concept that IAI has a beneficial impact not only on DME, but also on the underlying diabetic retinopathy.
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