The RECOVERY Study 2-Year Assessment of Longitudinal Panretinal Leakage Index Following Intravitreal Aflibercept for Proliferative Diabetic Retinopathy

Abstract

Purpose : To assess the 2-year longitudinal panretinal leakage index dynamics in proliferative diabetic retinopathy (PDR) treated with intravitreal aflibercept injections (IAI) utilizing quantitative ultra-widefield fluorescein angiography (UWFA).

Methods : The RECOVERY Study (NCT02863354) enrolled PDR subjects without vitreous hemorrhage (VH) or prior panretinal photocoagulation into 2 treatment groups. The 2q4 group was administered 2 mg IAI every 4 weeks and the 2q12 group received 2 mg IAI every 12 weeks (q12) for the first year. After year 1, both groups crossed-over to the other treatment regimen (2q4 to q12 dosing; and 2q12 to q4 dosing). UWFA imaging was obtained at baseline, 24, 48, 72, and 96 weeks. Following UWFA projection correction, images were evaluated with a quantitative UWFA assessment platform. All images were reviewed and corrected for segmentation errors by two masked expert readers. Panretinal leakage index reflects the percentage of leaking retinal area defined as the areas of leakage divided by the analyzable retinal area. Within group and between group comparative assessments were performed.

Results : Forty subjects were enrolled with a mean age of 48±12.1 years. After 2 years, the mean number of injections in the 2q4 arm was 16±1.01 and 13±4.63 in the 2q12 arm. The mean baseline panretinal leakage index were similar in the 2q4 and 2q12 groups: 6.4% and 4.4%, respectively (p = 0.28). Following the first year of therapy, both the 2q4 and 2q12 groups demonstrated similar and significant reduction in panretinal leakage index. Following the cross-over in therapy, both groups maintained significant reduction in panretinal leakage index at week 72 compared to baseline [2q4 group (-47%, p =0.01) and 2q12 group (-80%, p=0.01)]. At week 96, the panretinal leakage indices for the 2q4 and 2q12 groups were 3.7% (p=0.03) and 1.7% (p<0.01), respectively.

Conclusions : Eyes with PDR show large reductions in panretinal leakage index with IAI. Although 2q4 dosing provided more rapid reduction in leakage index compared to 2q12 dosing in the first year of the study, the cross-over in dosing regimens resulted in sustained reduction of the panretinal leakage index in both groups. The impact of quantitative leakage index as a possible biomarker for treatment indication merits further research.

This is a 2020 ARVO Annual Meeting abstract.