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Haley D'Souza, Kapil Kapoor, Alan Wagner; Ziv-aflibercept Efficacy in Better Regulating Neovascular AMD (ZEBRA) Trial. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5191.
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© ARVO (1962-2015); The Authors (2016-present)
The purpose of this study is to determine if ziv-aflibercept is a safe and effective alternative to currently available anti-VEGF medications used to treat neovascular age-related macular degeneration (nAMD).
This is a prospective, randomized, IRB-approved, case-control study of patients undergoing treatment for nAMD. Inclusion criteria were previous therapy with intravitreal bevacizumab, ranibizumab, and/or aflibercept and best corrected visual acuity (BCVA) ≤ 20/250. Exclusion criteria included active intraocular inflammation, recent vitreous hemorrhage, and uncontrolled glaucoma or ocular hypertension. The treatment group received 1.25 mg/0.05mL intravitreal ziv-aflibercept at their baseline treatment interval, while the control group continued their existing anti-VEGF regimen. Primary outcomes were BCVA and central foveal thickness (CFT).
Of the 52 patients enrolled, 26 patients have been enrolled for at least nine months, with 10 of those patients enrolled for at least 12 months. In these 26 patients, control group (n=12) mean baseline BCVA was 1.51±0.37 logMAR (Snellen equivalent: CF 6 ft); treatment group (n=14) mean baseline BCVA was 1.72±0.38 logMAR (Snellen equivalent: CF 5 ft). Mean change in BCVA during the study period was 0.17 logMAR in the control group and 0.07 logMAR in the treatment group (p=0.45). Baseline CFT in the control and treatment groups were 246±62 µm and 240±95 µm respectively. In the control and treatment groups, mean change in CFT was 40 µm and 21 µm respectively (p=0.49).Over the twelve months of the study, ziv-aflibercept has been well-tolerated and has not demonstrated any retinal toxicity or adverse effects such as retinal detachment, intraocular inflammation, intraocular infection, or vision loss. There was no significant change in mean arterial blood pressure in the control compared with the treatment group (p=0.35).
Our findings are that ziv-aflibercept is a safe and effective alternative to currently available anti-VEGF medications in treating patients with nAMD. Compared to aflibercept and bevacizumab, ziv-aflibercept is non-inferior with respect to anatomy, function, and complication rate. Due to ziv-aflibercept’s efficacy and relatively low cost, it may represent an important addition to current anti-VEGF treatment options, especially as a cost-effective alternative to aflibercept and a second-line therapy for eyes resistant to bevacizumab.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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