Three-Month Outcome of Ziv-aflibercept for exudative age-related macular degeneration

Abstract

Purpose : Aflibercept is an approved therapy for neovascular macular degeneration (AMD) while ziv-aflibercept is approved for oncology and is cost-effective relative to the expensive same molecule aflibercept. In vitro and in vivo studies did not detect toxicity to the retinal pigment epithelium cells using ziv-aflibercept. Our purpose is to ascertain the 3-month safety and efficacy in AMD treated with intravitreal ziv-aflibercept.

Methods : Prospectively, consecutive patients with wet age related macular degeneration that required aflibercept underwent ziv-aflibercept intravitreal injection of 0.05 ml of compounded ziv-aflibercept (1.25mg) from March 2015 to November 2015 in the Lebanese series and scattered select cases in the Indian cases. Monitoring of best-corrected visual acuity, intraocular inflammation, cataract progression, and retinal structure by spectral domain OCT were carried initially, one week, one month, two months and three months after injections. The study received Institutional Review Board approval and received the registration NCT02486484.

Results : 30 eyes were treated (22 Caucasians, 8 Indians; 16 men, 14 women; 14 right eye and 16 right eye) with mean age of 74.3 years with 11 naïve cases and 19 having had prior injections 4 months prior to our treatment. Best-corrected visual acuity improved from baseline logMar 1.08 to 0.74 at 1 week, 0.72 at 1 month, 0.67 at 2 month, and 0.71 at 3 month (p<0.001 for all time periods). CMT in microns decreased from 332.8 to 302.0 at 1 week, 244.8 at 1 month, 225.9 at 2 months and 208.2 at 3 month (p<0.001 for all time periods). There were no signs of intraocular inflammation, or change in lens status throughout the study. Intraocular pressure was unchanged initial and at 3 month in 10 eyes (12.8±2.3 mmHg vs. 12.8±2.2 mmHg). Significance was also present for the Lebanese series alone and for virgin cases in the Lebanese series.

Conclusions : Off label use of ziv-aflibercept improves visual acuity, without ocular toxicity and offers a cheaper alternative to the same molecule aflibercept, especially in the third world.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.