Ziv-aflibercept for Better Regulating Neovascular Age-Related Macular Degeneration (ZEBRA): A Prospective, Randomized Trial

Abstract

ABSTRACT Objective The purpose of this study is to determine if ziv-aflibercept is a safe and effective maintenance drug for nAMD. Study Design and Methods This is a randomized, prospective, single-blinded trial. Inclusion criteria were active nAMD, prior anti-VEGF treatment, and BCVA ≤20/200. The treatment group received ziv-aflibercept. The control group continued their existing anti-VEGF regimen. The main outcome measures were BCVA, CFT, and safety. Results Mean baseline BCVA was 1.58 ± 0.44 logMAR and 1.71 ± 0.39 logMAR in the control (n = 27) and treatment (n = 29) groups, respectively. After 24 months, the mean change in BCVA was 0.11 in the control group (equivalent to a loss of 5 ETDRS letters) and 0.01 logMAR in the treatment group (p = .48). Baseline CFT was 257 ± 33 μm and 247 ± 30 μm in the control and treatment groups, respectively, and after 24 months mean change in CFT was 26 μm and −5 μm (p = .24). There were no ocular or systemic adverse events during the study. Conclusion Ziv-aflibercept is a safe and effective as a maintenance drug for patients with nAMD. It may represent a cost-effective alternative to aflibercept and second-line therapy for eye resistant bevacizumab or ranibizumab.