A randomized trial tested three dosing schedules for aflibercept in patients with diabetic macular edema. The study included 658 adults aged 18 or older who had vision loss ranging from 20/32 to 20/320. Participants received initial monthly injections followed by extended intervals of either 8 mg every 12 weeks, 8 mg every 16 weeks, or the standard 2 mg every 8 weeks. The researchers followed the patients for 96 weeks to compare outcomes.
Results showed that the two higher-dose regimens produced visual and anatomical improvements comparable to the standard lower-dose schedule. Specifically, changes in best-corrected visual acuity and central retinal thickness were similar across all groups. Patients receiving 8 mg every 16 weeks maintained their dosing intervals in 83 percent of cases, while those on the standard schedule maintained theirs in 47 percent of cases.
Safety profiles were similar across all treatment groups. The incidence of ocular adverse events ranged from 37.1 percent to 45.4 percent in the study eye. No discontinuations due to safety issues were reported. This trial suggests that using aflibercept 8 mg at extended intervals can maintain treatment benefits while reducing the number of injections required over time.