Effect of Intravitreal Aflibercept on Diabetic Retinopathy Severity and Visual Function in Subjects with Proliferative Diabetic Retinopathy

Abstract

Purpose : To evaluate the effect of intravitreal aflibercept on diabetic retinopathy severity in subjects with proliferative diabetic retinopathy (PDR) without diabetic macular edema (DME).

Methods : Forty eyes of 40 subjects with PDR and no DME were enrolled in this prospective, longitudinal, IRB approved the multi-center clinical trial, the RECOVERY study (NCT02863354). Subjects were randomized into monthly and quarterly 2 mg aflibercept injection cohorts, treated over a period of 12 months. All subjects underwent ultra-widefield (UWF) fundus imaging including pseudocolor and fluorescein angiography at baseline using an Optos 200Tx device (Optos, Dunfermline, UK), with pseudo color images repeated at follow-up. The severity of retinopathy at baseline, month 6, and month 12 was evaluated by certified reading center graders using the diabetic retinopathy severity scale (DRSS). DRSS scores were correlated with the 25-item and 39-item Visual Function Questionnaire scores at baseline and month 12.

Results : The mean age of the subjects was 48.2 years (range 25-75), the mean duration of diabetes mellitus was 16.1 years (range 2-36 years) and mean HbA1c was 9.42% (range 6.0-17). The monthly group demonstrated a statistically significant greater regression of the DRSS score at the month 6 visit compared to the quarterly group (p= 0.02). However, the difference between the two groups became statistically insignificant by the month 12 visit (p= 0.31). There was also no difference in mean VFQ-25 and VFQ-39 composite scores between the monthly and quarterly groups at month 12 (p= 0.95, 0.92, respectively). The improvement in mean VFQ-25 and VFQ-39 composite scores at month 12, however, was significantly correlated with improvement in DRSS (r= 0.38, p= 0.04; r= 0.36, p= 0.046; respectively). Of note, improvement in DRSS was not correlated with change in best-corrected visual acuity (r= 0.12, p=0.50).

Conclusions : In this study of eyes with PDR without DME, monthly aflibercept injection was associated with greater regression of DRSS at month 6 compared to quarterly dosing, but this difference was not significant by month12. The improvement in DRSS was associated with an improvement in the VFQ composite score.

This is a 2020 ARVO Annual Meeting abstract.