Comparing the Efficacy of Bevacizumab and Ranibizumab in Patients with Retinal Vein Occlusion

血管抑制剂 医学 贝伐单抗 视力 眼科 黄斑水肿 置信区间 随机对照试验 视网膜中央静脉阻塞 不利影响 视网膜分支静脉阻塞 闭塞 外科 内科学 化疗
作者
Maartje J.C. Vader,Ann-Sofie M.E. Schauwvlieghe,Frank D. Verbraak,Greetje Dijkman,Johanna M. M. Hooymans,Leonoor I. Los,Aeilko H. Zwinderman,Tünde Petõ,Carel B. Hoyng,Redmer van Leeuwen,Johannes R. Vingerling,Yvonne de Jong‐Hesse,Janneke J.C. van Lith-Verhoeven,Marcel G. W. Dijkgraaf,Reinier O. Schlingemann
出处
期刊:Ophthalmology Retina [Elsevier]
卷期号:4 (6): 576-587 被引量:24
标识
DOI:10.1016/j.oret.2019.12.019
摘要

Comparing the efficacy of intravitreal injections of bevacizumab to ranibizumab in the treatment of macular edema (ME) resulting from retinal vein occlusion (RVO).Comparative, randomized, double-masked, multicenter, noninferiority clinical trial. The noninferiority margin was 4 letters.Patients with vision loss resulting from ME secondary to a branch or (hemi) central RVO who might benefit from anti-vascular endothelial growth factor treatment were eligible for participation.From June 2012 through February 2018, 277 participants were randomized to receive injections of 1.25 mg bevacizumab (n = 139) or 0.5 mg ranibizumab (n = 138). The follow-up was 6 months with a monthly dosing interval.The primary outcome was a change in visual acuity from baseline at 6 months. Changes in the central area thickness and safety were studied as secondary outcomes.The mean visual acuity (±standard deviation) improved, with 15.3±13.0 letters for bevacizumab and 15.5±13.3 letters for ranibizumab after 6 months of monthly treatment. The lower limit of the 2-sided 90% confidence interval was -1.724 letters, which is within the noninferiority margin of 4 letters. Even in the branch and (hemi-)central RVO subgroups, minimal differences were found in visual acuity outcomes between treatment arms. Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group. Severe adverse events (SAEs) were also distributed equally over both treatment groups: 10 participants (7.1%) in the bevacizumab group and 13 participants (9.2%) in the ranibizumab group experienced SAEs.This study showed, based on the change in visual acuity, that bevacizumab is noninferior to ranibizumab for patients with ME resulting from RVO of either subtype when receiving monthly injections for a period of 6 months. In addition, anatomic and safety outcomes did not differ between treatment groups. Based on our findings, bevacizumab may be an effective alternative to ranibizumab.
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