SHORT-TERM SAFETY OF 2 MG INTRAVITREAL ZIV-AFLIBERCEPT

To evaluate the safety of single intravitreal 2 mg ziv-aflibercept (0.08 mL) injections for the treatment of choroidal neovascular membranes (CNVM).

Eyes with choroidal neovascular membranes because of several conditions each received single intravitreal injections of 2 mg ziv-aflibercept (0.08 mL). Comprehensive ophthalmic examinations and detailed systemic evaluations were performed at baseline and Days 1, 7, and 30 after injections. Standard electroretinography was performed at baseline and Day 30. Primary outcome measures consisted of safety assessments (signs of clinical toxicity and electroretinographic abnormalities). Secondary outcome measures included changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) of the macula.

Twenty-one eyes of 20 patients (12 males) received injections. Etiologies responsible for the choroidal neovascular membranes included age-related macular degeneration (14), polypoidal choroidal vasculopathy (PCV) (3), myopia (2), and idiopathic juxtafoveal telangiectasia (2). None of the patients complained of worsening vision or pain after the intravitreal injections and no intraocular inflammation was seen. No significant changes in the electroretinographic b/a ratio from baseline to 1 month were measured (scotopic: P = 0.89; photopic: P = 0.13) and mean intraocular pressures were unchanged (14.2 ± 3.6 vs. 13.7 ± 3.0 mmHg; P = 0.62). Mean best-corrected visual acuity did not change significantly from baseline to 1 month (0.66 ± 0.37 logMAR [Snellen equivalent: 20/100] vs. 0.61 ± 0.35 logMAR [Snellen equivalent: 20/80]; P = 0.72) but significant improvements in central subfield thickness were seen (343 ± 177 vs. 210 ± 133 μm; P = 0.01).

Single intravitreal injections of 2 mg ziv-aflibercept (0.08 mL) appear to be safe through 1 month.