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SHORT-TERM SAFETY OF 2 MG INTRAVITREAL ZIV-AFLIBERCEPT

Chhablani, Jay MS*; Dedhia, Chintan Jethalal MS*; Peguda, Hari K. BS opt*; Stewart, Michael MD

doi: 10.1097/IAE.0000000000001440
Original Study
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SDC

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

Methods: 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.

Results: 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).

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

This pilot study demonstrates the short-term safety of single intravitreal injections of 2 mg (0.08 mL) ziv-aflibercept in patients with choroidal neovascular membranes. No signs of toxicity were seen on clinical examination or with electroretinographic testing at one month. Further studies are needed to determine the long-term safety and clinical efficacy of the 2-mg dose.

*Srimati Kanuri Santhamma Centre for Vitreo-Retinal Diseases, Hyderabad Eye Research Foundation, Kallam Anji Reddy Campus, L V Prasad Eye Institute, Hyderabad, India; and

Department of Ophthalmology, Mayo Clinic, Jacksonville, Florida.

Reprint requests: Jay Chhablani, Srimati Kanuri Santhamma Centre for Vitreo-Retinal Diseases, Kallam Anji Reddy Campus, L V Prasad Eye Institute, L V Prasad Marg, Banjara Hills Hyderabad, Telangana 500 034, India; e-mail: jay.chhablani@gmail.com

None of the authors has any financial/conflicting interests to disclose.

© 2017 by Ophthalmic Communications Society, Inc.