Real-World Data on Intravitreal Aflibercept for Macular Edema Secondary to Central Retinal Vein Occlusion: 24-Month Outcomes

Abstract

Purpose To report on the safety and effectiveness of intravitreal aflibercept (IVT-AFL) for macular edema secondary to central retinal vein occlusion (CRVO) in clinical practice in Japan. Patients and Methods This prospective, noninterventional, multicenter post-authorization safety study enrolled patients who were treated with IVT-AFL for macular edema secondary to CRVO and followed up for 24 months. The primary outcome was the occurrence of safety events. Other pre-specified outcomes were indicators of effectiveness, including best corrected visual acuity (BCVA), central retinal thickness (CRT), and frequency of injections. Results The safety analysis included 377 patients who received at least one IVT-AFL. Adverse events (AEs) occurred in 22 patients (5.84%) and adverse drug reactions occurred in 5 (1.33%) over 24 months. Of the 22 patients with AEs, 72.7% experienced their first AEs by the third injection. The effectiveness analysis set comprised 360 patients for whom data on each outcome could be collected. The number of injections over 24 months was 3.4 ± 2.4 (mean ± standard deviation [SD]). BCVA (logarithm of the minimum angle of resolution) was 0.709 ± 0.535 (mean ± SD) ( n = 357) at baseline and 0.543 ± 0.559 ( n = 97) after 24 months of treatment with IVT-AFL. CRT was 552.6 ± 211.3 μm (mean ± SD) ( n = 214) at baseline and 331.5 ± 144.0 μm ( n = 54) at 24 months. Conclusion There were no new safety issues concerning routine administration of IVT-AFL for macular edema secondary to CRVO. BCVA recovered during 24 months of IVT-AFL treatment in the real-world setting. However, there was a trend toward less improvement compared with the results of randomized controlled trials, likely due in part to undertreatment.

Background diseases and the number of previous intravitreal aflibercept injections on immediate intraocular pressure increase and vitreous reflux rate in phakic eyes

“…N owadays, intravitreal aflibercept (Eylea ® ; Regeneron, Tarrytown, NY, USA) injection (IVAI) is extensively used for diabetic macular edema (DME) [1] , neovascular agerelated macular degeneration (nAMD) [2] , cystoid macular edema (CME) secondary to retinal vein occlusion (RVO) [3][4] , and myopic choroidal neovascularization (CNV) [5] treatment in Japan. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) antibody including aflibercept, causes an immediate increase of the intraocular pressure (IOP) [6][7][8] .…”