Ziv-Aflibercept for Diabetic Macular Edema
Ophthalmology Retina, May 2018
Ziv-aflibercept, a recombinant fusion protein, has a mechanism that is similar in action to that of aflibercept—and is available at a lower cost than the proprietary anti–vascular endothelial growth factor (VEGF) drug. Bonyadi et al. set out to evaluate 2 doses of ziv-aflibercept and compare them with intravitreal bevacizumab for the treatment of center-involving diabetic macular edema (DME). They found that patients who received ziv-aflibercept improved more than those who received bevacizumab, with the caveat that the greatest improvement was noted in those eyes that had the worst visual acuity (VA) at baseline.
For this 1-year double-blind study, the researchers randomly assigned 123 eyes with center-involving DME to 1 of 3 arms: 1) 2.5 mg of intravitreal ziv-aflibercept (n = 42); 2) 1.25 mg of intravitreal ziv-aflibercept (n = 42); and 3) 1.25 mg of intravitreal bevacizumab (n = 39). Initially, all patients were treated every 4 weeks for 3 loading injections. After that, patients in the bevacizumab cohort were treated every 4 weeks, while those in the 2 ziv-aflibercept cohorts were treated every 8 weeks. The main outcome measure was change in best-corrected VA (BCVA) at 1 year.
At final follow-up, BCVA was superior in the ziv-aflibercept patients to that of those who received bevacizumab, with mean improvements of 16 and 18 ETDRS letters found for ziv-aflibercept 2.5 mg and 1.25 mg, respectively, versus 14 letters for bevacizumab. This effect was pronounced in those patients who had worse levels of vision at baseline (defined as ≤ 20/50)—improvements of 24, 25, and 14 letters were found for the 2.5-mg ziv-aflibercept, 1.25-mg ziv-aflibercept, and bevacizumab groups, respectively.
With regard to central macular thickness (CMT), the final measurement was less than 250 μm in 64.7% of those who received 2.5 mg of ziv-aflibercept, 53.3% of the 1.25-mg ziv-aflibercept cohort, and 40% of those who received bevacizumab.
All told, those who received 2.5 mg of ziv-aflibercept were given an average of 6.71 injections, versus 6.67 injections in the 1.25-mg ziv-aflibercept arm and 11.56 in the bevacizumab arm. No cases of major ocular or systemic complications were noted.
The original article can be found here.