Retinal Nonperfusion (RNP) Extent and its Relationship with Visual, Anatomic and Disease State Outcomes Among Eyes Treated for Diabetic Macular Edema (DME)

Abstract

Purpose : Evaluate the relationship between macular RNP area quantified in mm² and visual and anatomic outcomes as well as the impact of baseline RNP area on the incidence of proliferative diabetic retinopathy (PDR) events in eyes treated for DME through 2 years in the VISTA phase 3 trial.

Methods : Post hoc analysis included 178 of 466 eyes randomized in VISTA that had FA images available at baseline and weeks 52 and 100, with quantifiable RNP at baseline, and received intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4, n=60), IAI 2 mg every 8 weeks following 5 monthly doses (2q8, n=55), or laser control (n=63). RNP was quantified in mm² at baseline and weeks 24, 52, and 100 by a masked reading center. PDR events were defined as PDR, pan retinal photocoagulation, or vitrectomy. Macular RNP area was analyzed by MMRM, correlation by Pearson & Spearman methods, and the effect of baseline RNP area on PDR events by Cox’s model.

Results : At baseline, mean RNP areas were 1.7, 1.5, and 1.5 mm² in the 2q4, 2q8, and laser control groups, respectively. At week 100, the corresponding mean change (95% CI) from baseline in RNP area was -0.7 (-1.0, -0.2), -0.6 (-1.1, -0.3), and -0.2 (-0.6, 0.2) mm², respectively. At week 100, reductions in RNP from baseline with 2q4 and 2q8 were correlated with changes from baseline in best-corrected visual acuity (BCVA) (r=-0.6 and -0.5, P<0.05; respectively) and central retinal thickness (CRT) (r=0.7 and 0.4, P<0.05; respectively), but not with changes from baseline in DRSS score (r=0.4 and 0.1). In the laser control group, there was no correlation between changes from baseline in RNP with BCVA, CRT, and DRSS score. Overall, 2.8% (3/108) and 14% (8/57) of eyes with baseline RNP in the combined IAI and laser control groups, respectively, developed a PDR event through week 100. Compared to eyes with baseline RNP of ≤0.615 mm², PDR events (hazard ratio [95% CI]) occurred 2.1 (0.2, 22.7) times and 9.2 (1.2, 73.6) times higher in eyes with baseline RNP areas of >0.615-≤1.255 mm² and >1.255 mm², respectively.

Conclusions : Significant reductions in macular RNP with anti-VEGF treatment with aflibercept were correlated with improvements in BCVA and CRT. Greater extent of baseline RNP area was associated with greater likelihood of developing a PDR event through week 100.

This is a 2020 ARVO Annual Meeting abstract.