Randomized control trial details
The study recruited 135 eyes of 93 patients that were randomly assigned to intravitreal treatment with ziv-aflibercept 2.5 mg/0.1 mL, ziv-aflibercept 1.25 mg/0.05 mL, or bevacizumab 1.25 mg/0.05 mL. Ziv-aflibercept was administered as three loading doses at 4-week intervals and then every 8 weeks. Bevacizumab was administered on a monthly basis.
A total of 123 eyes (83 patients) completed all visits. No eyes required retinal photocoagulation, vitrectomy, or cataract surgery. The mean number of injections administered was about 6.7 in each of the ziv-aflibercept groups and 11.6 for bevacizumab.
BCVA analyses showed that compared with the bevacizumab-treated eyes, mean BCVA improvement in the 2.5 and 1.25 mg ziv-aflibercept groups was 0.20 and 0.16 logMAR greater, respectively. Percentages of eyes achieving >0.2 logMAR improvement of BCVA was also significantly greater in the ziv-aflibercept groups.
Among eyes with initial BCVA ≤20/50, a 2-line improvement in BCVA was achieved in 95% of eyes treated with ziv-aflibercept 2.5 mg, 91% of those treated with ziv-aflibercept 1.25 mg, and 67% of bevacizumab-treated eyes.
Overall, final CMT was <250 µm in 65% of eyes treated with ziv-aflibercept 2.5 mg, 53% of the eyes treated with ziv-aflibercept 1.25 mg, and 40% of bevacizumab-treated eyes.