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Masahiko Shimura,1 Makoto Fukumatsu,2 Jun Tsujimura,2 Kazufumi Hirano,2 Toshiyuki Sunaya3 On behalf of the Participating Investigators1Department of Ophthalmology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan; 2Medical Affairs & Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan; 3Research & Development Japan, Bayer Yakuhin, Ltd., Osaka, JapanCorrespondence: Masahiko Shimura, Department of Ophthalmology, Tokyo Medical University Hachioji Medical Center, 1163 Tate-machi, Hachioji, Tokyo, 193-0998, Japan, Tel +81 42 665 5611, Fax +81 42 665 1976, Email masahiko@v101.vaio.ne.jpPurpose: 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.Keywords: central retinal vein occlusion, macular edema, intravitreal aflibercept, anti-vascular endothelial growth factor treatment, real-world data |
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