The 2-Year Leakage Index and Quantitative Microaneurysm Results of the RECOVERY Study: Quantitative Ultra-Widefield Findings in Proliferative Diabetic Retinopathy Treated with Intravitreal Aflibercept.

Amy S Babiuch,Hannah Yu,Charles C Wykoff,Sari Yordi,Leina Lunasco,Jamie Reese,Ming Hu,Sunil K Srivastava,Muneeswar G Nittala,Thuy K Le,Justis P Ehlers,Srinivas R Sadda

doi:10.3390/jpm11111126

Abstract

Eyes with proliferative diabetic retinopathy (PDR) have been shown to improve in the leakage index and microaneurysm (MA) count after intravitreal aflibercept (IAI) treatment. The authors investigated these changes via automatic segmentation on ultra-widefield fluorescein angiography (UWFA). Forty subjects with PDR were randomized to receive either 2 mg IAI every 4 weeks (Arm 1) or every 12 weeks (Arm 2) through Year 1. After Year 1, Arm 1 switched to quarterly IAI and Arm 2 to monthly IAI through Year 2. By Year 2, the Arm 1 leakage index decreased by 43% from Baseline (p = 0.03) but increased by 59% from Year 1 (p = 0.04). Arm 2 decreased by 61% from Baseline (p = 0.008) and by 31% from Year 1 (p = 0.12). Both cohorts exhibited a significant decline in MAs from Baseline to Year 2 (871 to 410; p < 0.001; 776 to 207; p < 0.001, respectively). Subjects with an improved leakage and MA count showed a more significant improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Moreover, central subfield thickness (CST) was positively associated with changes in the leakage index. In conclusion, the leakage index and MA counts significantly improved from Baseline following IAI treatment, and monthly injections provided a more rapid and sustained reduction in these parameters compared with quarterly injections.

Highlights

Over 34.2 million people in the United States have Type I or Type II diabetes mellitus, and 88 million US adults have prediabetes [1]
The development of retinal ischemia in DR triggers the release of the Vascular Endothelial
The purpose of this study is to assess longitudinally the MA count and leakage occurring on ultra-widefield fluorescein angiography (UWFA) images over a 2-year period in patients with proliferative diabetic retinopathy (PDR) being treated with a fixed-interval intravitreal aflibercept

Summary

Introduction

Over 34.2 million people in the United States have Type I or Type II diabetes mellitus, and 88 million US adults have prediabetes [1]. Diabetic retinopathy (DR), the most common form of diabetic-related eye disease, is the leading cause of visual impairment and blindness in working-age Americans, and is expected nearly to double from 2010 to 2050. (7.7 million to 14.6 million) [2]. To have vision-threatening complications such as proliferative diabetic retinopathy (PDR). Diabetic macular edema (DME) [3]. Vision-threatening complications in DR arise from prolonged hyperglycemia causing a cascade of biochemical pathways. These pathways lead to oxidative stress in the retinal vasculature and subsequently cause microvascular dysfunction. The development of retinal ischemia in DR triggers the release of the Vascular Endothelial

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