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Ranibizumab: in macular oedema following retinal vein occlusion.

机译:雷尼单抗:在视网膜静脉阻塞后发生黄斑水肿。

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摘要

Ranibizumab (Lucentis(R)), a recombinant humanized IgG(1) kappa isotype monoclonal antibody fragment, is approved in the US for the treatment of macular oedema following retinal vein occlusion (RVO). It binds to the receptor-binding site of active forms of vascular endothelial growth factor-A, inhibiting its biological activity. In two large, well designed, phase III trials in patients with macular oedema following branch RVO (BRVO) or central RVO (CRVO), monthly intravitreal injections of ranibizumab 0.5 mg were associated with significantly greater improvement from baseline in mean best-corrected visual acuity letter score (measured on the Early Treatment Diabetic Retinopathy Study chart) in the study eye at 6 months (primary endpoint) than sham injections. Moreover, ranibizumab was significantly more effective than sham injections with regard to improvements in central foveal thickness at 6 months, as well as several other visual acuity measures. Ranibizumab was generally well tolerated in patients with macular oedema following CRVO or BRVO. Overall, the most common adverse events with ranibizumab were consistent with the adverse event profile previously reported in patients with age-related macular degeneration.
机译:Ranibizumab(Lucentis®)是一种重组人源化IgG(1)κ同种型单克隆抗体片段,已在美国获准用于治疗视网膜静脉闭塞(RVO)后的黄斑水肿。它与血管内皮生长因子-A活性形式的受体结合位点结合,从而抑制其生物学活性。在两项针对RVO(BRVO)或中枢RVO(CRVO)引起的黄斑水肿患者的三项精心设计的大型III期试验中,每月玻璃体内注射兰尼单抗0.5 mg与平均最佳矫正视力较基线水平有明显改善有关与假注射相比,在第6个月(主要终点)研究眼中的字母得分(根据早期糖尿病性视网膜病变研究图测量)。此外,在改善6个月中央凹中央厚度以及其他几种视敏度方面,兰尼单抗明显优于假注射。雷诺单抗通常在CRVO或BRVO后发生黄斑水肿的患者中得到很好的耐受。总的来说,兰尼单抗最常见的不良事件与先前在年龄相关性黄斑变性患者中报道的不良事件相一致。

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