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Ranibizumab for the treatment of wet AMD: a summary of real-world studies

机译:雷尼单抗治疗湿性AMD:现实世界研究总结

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摘要

Data from real-world studies of ranibizumab in neovascular (wet) age-related macular degeneration suggest that outcomes in clinical practice fail to match those seen in clinical trials. These real-world studies follow treatment regimens that differ from the fixed dosing used in the pivotal clinical trial programme. To better understand the effectiveness of ranibizumab in clinical practice, we conducted a comprehensive evaluation of 12-month outcomes reported in peer-reviewed ‘real-world' publications. Key measures included in our analysis were mean change in visual acuity (VA) and the proportion of patients gaining ≥15 letters or losing ≤15 letters. Twenty studies were eligible for inclusion in our study, with 18 358 eyes having sufficient data for analysis of 12-month outcomes. Mean baseline VA ranged from 48.8 to 61.6 Early Treatment Diabetic Retinopathy Study letters. Mean change in VA was between −2.0 and +5.5 letters, with a grand mean of +2.9±3.2, and a weighted mean (adjusted for the number of eyes in the study) of +1.95. Eleven studies reported that 19±7.5 (mean value) of patients gained ≥15 letters, while in 12 studies the mean percentage of patient losing ≤15 letters was 89±6.5%. Our comprehensive analysis of real-world ranibizumab study data confirm that patient outcomes are considerably poorer than those reported in randomised control trials of both fixed and pro re nata regimens.
机译:雷尼单抗在新生血管(湿性)与年龄相关的黄斑变性中的现实研究数据表明,临床实践中的结果与临床试验中的结果不符。这些实际研究遵循的治疗方案不同于关键临床试验方案中使用的固定剂量。为了更好地了解兰尼单抗在临床实践中的有效性,我们对同行评审的“真实世界”出版物中报告的12个月结果进行了全面评估。我们分析中的关键指标是视力的平均变化(VA)和获得≥15个字母或丢失≤15个字母的患者比例。二十项研究符合纳入我们的研究的条件,其中18 358眼有足够的数据来分析12个月的结果。平均基线VA在48.8至61.6的早期治疗糖尿病性视网膜病研究信中。 VA的平均变化在-2.0到+5.5个字母之间,较大平均值为+ 2.9±3.2,加权平均值(根据研究中的眼睛数量进行调整)为+1.95。十一项研究报告说,19±7.5(平均值)的患者获得≥15个字母,而在十二项研究中,丢失≤15个字母的患者的平均百分比为89±6.5%。我们对现实中兰尼单抗研究数据的全面分析证实,与固定方案和前列腺癌方案的随机对照试验相比,患者的结局要差得多。

著录项

  • 期刊名称 Eye
  • 作者

    V Chong;

  • 作者单位
  • 年(卷),期 2016(30),2
  • 年度 2016
  • 页码 270–286
  • 总页数 17
  • 原文格式 PDF
  • 正文语种
  • 中图分类 眼科学;
  • 关键词

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