玻璃体内注射雷珠单抗治疗糖尿病性黄斑水肿的常规实践：来自德国一项非干预性多中心研究的两年真实世界数据。
Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany.
作者信息
Ziemssen Focke, Wachtlin Joachim, Kuehlewein Laura, Gamulescu Maria-Andreea, Bertelmann Thomas, Feucht Nikolaus, Voegeler Jessica, Koch Mirja, Liakopoulos Sandra, Schmitz-Valckenberg Steffen, Spital Georg
机构信息
Centre for Ophthalmology, Eberhard-Karls-University Tuebingen, Tuebingen, Germany.
St. Gertrauden Krankenhaus, Berlin, Germany.
出版信息
Diabetes Ther. 2018 Dec;9(6):2271-2289. doi: 10.1007/s13300-018-0513-2. Epub 2018 Oct 4.
INTRODUCTION
The prospective, non-interventional OCEAN study examined the use of intravitreal ranibizumab injections for the treatment of diabetic macular oedema (DME) in a real-world setting in Germany.
METHODS
Adults with DME receiving ≥ 1 ranibizumab (0.5 mg) injections were recruited by 250 ophthalmologists. Best-corrected visual acuity (VA) testing, imaging and treatments were performed according to the investigators' routine practice and documented over 24 months.
RESULTS
The full analysis set included 1226 participants. Mean baseline VA was 60.6 [95% CI: 59.7; 61.5] Early Treatment Diabetic Retinopathy Study letters. VA improved by ≥ 15 letters in 21.5% and 23.5% of the participants at 12 months and 24 months, respectively. They received a mean number of 4.42 [95% CI: 4.30; 4.54] injections in the first year and 5.52 [95% CI: 5.32; 5.73] injections over 24 months, which was markedly lower than in clinical trials. Only 33.4% of the participants received an upload with four initial monthly injections as recommended by the German ophthalmologic societies. Time-to-event analyses that account for missing data inherent to a non-interventional study design demonstrated that participants receiving ≥ 7 injections in the first year had a faster response, but the duration of the response was shorter compared to the subgroups receiving 1-3 and 4-6 injections. Serious adverse events were reported for 143/1250 (11.4%) participants in the safety population.
CONCLUSION
Under-treatment is a major problem of DME anti- vascular endothelial growth factor therapy under real life conditions. Despite fewer injections given compared to randomised controlled trials with a consequently reduced overall mean visual gain, a profound functional improvement (≥ 15 letters) was achieved over 2 years in 23.5% of eyes with DME.
TRIAL REGISTRATION NUMBER
NCT02194803, ClinicalTrials.gov.
FUNDING
Novartis Pharma GmbH, Nuremberg, Germany.
引言
前瞻性、非干预性的OCEAN研究在德国的实际临床环境中，考察了玻璃体内注射雷珠单抗治疗糖尿病性黄斑水肿（DME）的应用情况。
方法
250名眼科医生招募了接受过≥1次雷珠单抗（0.5mg）注射的DME成年患者。最佳矫正视力（VA）检测、成像和治疗均按照研究者的常规操作进行，并记录24个月的数据。
结果
完整分析集包括1226名参与者。平均基线视力为60.6 [95%可信区间：59.7；61.5] 早期糖尿病性视网膜病变研究字母表视力。在12个月和24个月时，分别有21.5%和23.5%的参与者视力提高≥15个字母。他们在第一年平均接受4.42 [95%可信区间：4.30；4.54]次注射，在24个月内平均接受5.52 [95%可信区间：5.32；5.73]次注射，这明显低于临床试验中的次数。只有33.4%的参与者按照德国眼科学会的建议接受了最初每月4次注射的强化治疗。考虑到非干预性研究设计中固有的缺失数据的事件发生时间分析表明，第一年接受≥7次注射的参与者反应更快，但与接受1 - 3次和4 - 6次注射的亚组相比，反应持续时间较短。在安全人群中，143/1250（11.4%）的参与者报告了严重不良事件。
结论
在现实生活条件下，治疗不足是DME抗血管内皮生长因子治疗的一个主要问题。尽管与随机对照试验相比注射次数较少，总体平均视力提高相应减少，但23.5%的DME患眼在2年内仍实现了显著的功能改善（≥15个字母）。
试验注册号
NCT02194803，ClinicalTrials.gov。
资助
德国纽伦堡的诺华制药有限公司。
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