One-Year Results of a Trial Comparing 2 Doses of Intravitreal Ziv-aflibercept versus Bevacizumab for Treatment of Diabetic Macular Edema

Abstract

To report 1-year findings of a trial comparing 2 doses of intravitreal ziv-aflibercept (IVZ) with intravitreal bevacizumab (IVB) for treatment of center-involving diabetic macular edema (DME). Three-armed double-blind randomized clinical trial. A total of 123 eyes with center-involving DME. In this clinical trial, eyes with DME were randomly assigned to 2.5 mg intravitreal ziv-aflibercept (42 eyes), 1.25 mg intravitreal ziv-aflibercept (42 eyes), and 1.25 mg IVB injections (39 eyes), every 4 weeks for 3 loading injections and then every 4 weeks for IVB and every 8 weeks for ziv-aflibercept injections. The patients were followed up to 1 year with complete ophthalmologic examination and central macular thickness (CMT) measurement by optical coherence tomography. Change in best-corrected visual acuity (BCVA) at 1 year. Although no significant difference was evident between the 2 ziv-aflibercept groups at 1 year, BCVA change was significantly better in both ziv-aflibercept groups (-0.33±0.26 and-0.38±0.34 logarithm of the minimum angle of resolution (logMAR) equal to 16 and 18 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, for IVZ 2.5 and 1.25 mg, respectively) than in the IVB group (-0.26±0.35 logMAR, equal to 14 ETDRS letters) at final follow-up (P= 0.007 for IVZ 2.5 mg and P= 0.029 for IVZ 1.25 mg). Regarding CMT changes, there was no significant difference between the 2 ziv-aflibercept groups; however, a significantly greater reduction in CMT was observed in the ziv-aflibercept 2.5 mg group in comparison to the IVB group at 1 year (P= 0.029). Subgroup analysis disclosed no difference in BCVA outcomes at 1 year among the eyes with baseline BCVA >20/50. In the eyes with baseline BCVA ≤20/50, however, the improvement was significantly better at 1 year in both ziv-aflibercept groups compared with the IVB group (P= 0.002 for IVZ 2.5 mg and P= 0.001 for IVZ1.25 mg). The 1-year results of this trial disclosed more vision improvement with IVZ compared with IVB in the treatment of center-involving DME. This stronger effect of IVZ, however, was detected in the eyes with initial worse level of vision (≤20/50).