Abstract
Purpose :
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).
Methods :
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 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 best corrected visual acuity (BCVA) and central foveal thickness (CFT).
Results :
56 patients were enrolled. In the control group (n=27), mean baseline BCVA was 1.60±0.16 logMAR (Snellen equivalent: CF 6 ft); in the treatment group (n=29), mean baseline BCVA was 1.77±0.13 logMAR (Snellen equivalent: CF 5 ft). Mean change in BCVA during the study period was 0.17 logMAR in the control group and -0.03 logMAR in the treatment group (p=0.12). Baseline CFT in the control and treatment groups were 271±32 µm and 247±30 µm respectively. In the control and treatment groups, mean change in CFT was -26 µm and 5 µm respectively (p=0.33).
Over the eighteen months of the study, ziv-aflibercept as 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).
Conclusions :
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, 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 is a 2020 ARVO Annual Meeting abstract.