Intravitreal Aflibercept Injection in Diabetic Macular Edema Patients with and without Prior Anti-Vascular Endothelial Growth Factor Treatment Outcomes from the Phase 3 Program

Purpose: To evaluate visual and anatomic outcomes after intravitreal aflibercept injection (IAI) versus laser in diabetic macular edema (DME) patients with and without prior anti-vascular endothelial growth factor (VEGF) treatment for DME. Design: Post hoc analysis of eyes from 2 similarly designed, phase 3 trials, VISTA and VIVID. Participants: Patients (eyes) with DME with central involvement from VISTA (n = 461) and VIVID (n = 404). Methods: Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or macular laser photocoagulation. Main Outcome Measures: This study reports exploratory outcomes through week 100. Analyses focused on VISTA because more patients received prior anti-VEGF therapy in VISTA (42.9%) versus VIVID (8.9%). Results: Of 42.9% of patients in VISTA who received prior anti-VEGF treatment, 83.3% to 92.6% received >= 1 prior injections of bevacizumab, and 71.4% to 82.4% received bevacizumab only as prior anti-VEGF treatment for a duration ranging from 28 days to 3.9 years. In patients with prior anti-VEGF treatment, mean best-corrected visual acuity (BCVA) changes from baseline in the IAI 2q4, IAI 2q8, and laser groups were +10.4 letters, +10.5 letters, and -0.7 letters at week 52 and +10.9 letters, +10.8 letters, and -0.8 letters at week 100, respectively. Corresponding changes in patients without prior anti-VEGF treatment were +14.1 letters, +11.0 letters, and +0.9 letters at week 52 and +12.0 letters, +11.3 letters, and +2.1 letters at week 100. In patients with prior anti-VEGF treatment, mean reductions in central retinal thickness were 180.2 mu m, 192.2 mu m, and 90.9 mu m at week 52 and 180.1 mu m, 196.4 mu m, and 94.1 mu m at week 100. Corresponding reductions in patients without prior anti-VEGF treatment were 190.3 mu m, 175.7 mu m, and 61.0 mu m at week 52 and 200.0 mu m, 186.7 mu m, and 76.9 mu m at week 100. The most frequent serious ocular adverse event was vitreous hemorrhage (1.3%, 0.7%, and 1.9%, respectively). Conclusions: Visual and anatomic improvements over laser with both IAI regimens were significant and similar through week 100 in subgroups of patients in VISTA with and without prior anti-VEGF treatment for DME. (C) 2016 by the American Academy of Ophthalmology.