The Neovascular Age-Related Macular Degeneration Database: Multicenter Study of 92 976 Ranibizumab Injections
The Neovascular Age-Related Macular Degeneration Database: Multicenter Study of 92 976 Ranibizumab Injections
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DOI：
10.1016/j.ophtha.2013.11.031
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发表时间：
2014-05-01
期刊：
影响因子：
13.7
通讯作者：
Bunce, Catey
中科院分区：
文献类型：
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作者：
Tufail, Adnan;Xing, Wen;Bunce, Catey
目的：研究真实世界中雷珠单抗治疗新生血管性年龄相关性黄斑变性 (nAMD) 初治眼的情况，并制定护理基准标准。设计：多中心、国家 nAMD 数据库研究。参与者：11 135 名患者的 12 951 只眼睛中总共 92 976 次治疗。方法：从 14 个英国中心远程提取长达 5 年的常规收集匿名数据，并提取到中央中心使用电子病历（EMR）系统的数据库。参与中心使用雷珠单抗治疗 nAMD，采用 3 个月注射的负荷阶段和 Pro re nata 重新治疗方案。在首次患者数据输入之前定义并由 EMR 系统强制执行的最小数据集包括年龄、所有就诊时的早期治疗糖尿病视网膜病变研究视力 (VA) 以及注射次数。主要结果指标：基线 VA、VA 变化、治疗和就诊次数以及影响 VA 变化的基线特征。结果：对来自超过 300 000 次就诊（280 万个数据点）的信息进行了整理。首次治疗时的平均年龄为 79.1 岁，女性比例为 1.7:1。从 55 个字母的基线开始，随访至少 3 年的眼睛平均 VA（字母）为：1 年时 57 (+2) 个字母，2 年时 56 (+1) 个字母，3 年时 53 (-2) 个字母。第 1 年、第 2 年和第 3 年避免中度视力丧失的眼睛比例分别为 90%、84% 和 82%。 VA 为 20/40 或更好的眼睛比例为： 基线，16%；第一年，30%；第 2 年，30%；第三年，29%。第 1 年、第 2 年和第 3 年随访至少 3 年的眼部治疗中位次数分别为 5 次、4 次和 4 次，门诊就诊次数中位分别为 9.2 次、8.2 次和 8.2 次。基线 VA 与 3 个月时的平均视力增益呈负相关。年龄较大与视力下降相关。结论：英国许多中心获得的真实视觉结果与大多数随机试验中获得的结果并不相符，但它们的注射次数和就诊次数要少得多。这项研究提供了重要的基准结果，患者、视网膜专家和卫生保健专员应该会感兴趣。这项研究证明了 EMR 系统对未来 4 期和 5 期临床试验的潜在用途。 (C) 2014 年由美国眼科学会颁发。
Purpose: To study real-world ranibizumab therapy for treatment-naive eyes with neovascular age-related macular degeneration (nAMD) and to benchmark standards of care.Design: Multicenter, national nAMD database study.Participants: A total of 92 976 treatment episodes from 12 951 eyes of 11 135 patients.Methods: Up to 5 years of routinely collected, anonymized data were extracted remotely from 14 United Kingdom centers to a central database using an electronic medical record (EMR) system. Participating centers used ranibizumab to treat nAMD using a loading phase of 3 monthly injections and a pro re nata retreatment regimen. The minimum data set defined before first patient data entry and mandated by the EMR system included age, Early Treatment Diabetic Retinopathy Study visual acuity (VA) at all visits, and injection episodes.Main Outcome Measures: Baseline VA, change in VA, number of treatments and clinic visits, and baseline characteristics affecting VA change.Results: Information from more than 300 000 clinic visits (2.8 million data points) were collated. Mean age at first treatment was 79.1 years, with a female preponderance of 1.7: 1. Mean VA (letters) for eyes followed up for at least 3 years from a baseline of 55 letters was 57 (+2) letters at 1 year, 56 (+1) letters at 2 years, and 53 (-2) letters at 3 years. The proportion of eyes that avoided moderate vision loss at years 1, 2, and 3 were 90%, 84%, and 82%, respectively. The proportion of eyes with VA of 20/40 or better were: baseline, 16%; year 1, 30%; year 2, 30%; and year 3, 29%. The median number of treatments for eyes followed up for at least 3 years in years 1, 2 and 3 was 5, 4, and 4, respectively, and the median number of outpatient visits was 9.2, 8.2, and 8.2, respectively. Baseline VA was related inversely to mean vision gain at 3 months. Older age was associated with lower presenting VA.Conclusions: Real-world visual outcomes achieved at a large number of centers across the United Kingdom do not match the results achieved in most randomized trials, but they were delivered with substantially fewer injections and hospital visits. This study provides important benchmark results that should be of interest to patients, retina specialists, and commissioners of health care. This study demonstrates the EMR system's potential usefulness for future phase 4 and 5 clinical trials. (C) 2014 by the American Academy of Ophthalmology.