Secondary Data Analysis of the Data from Comparison of AMD Treatments Trials

对与年龄相关的比较数据的补充分析 黄斑变性治疗试验(CATT) (NEI次级数据分析研究助学金 (R21)) 摘要 拟议的项目将利用从比较中获得的综合数据集 多中心老年性黄斑变性(AMD)治疗试验(CATT) 由国家眼科研究所赞助的非劣势临床试验，以评估 雷尼比珠单抗(Lucentis)和贝伐单抗(阿瓦斯丁)的疗效和安全性 每月治疗或PRN(Prore Nata)。这项提案的具体目标不包括 CATT研究的主要目标，这些目标已经实现。相反， 拟议的项目涉及对CATT数据集进行额外的二级分析，以 实现以下重要的新目标： (1)描述两年内视力随时间变化的反应模式 治疗，并确定短期视力反应是否(术后1 或3次注射)预测长期(2年)视力反应。 (2)描述OCT和荧光素血管造影术捕捉到的形态变化 在治疗2年内随时间推移，并评估是否在形态上 3个月的反应预示着2年后的长期形态反应。 (3)探讨视力与视力变化的关系。 血管内皮生长因子治疗2年。 (4)描述治疗模式，并确定与 治疗PRN 2年的患者治疗次数少。 (5)从形态上评估基因-表型之间的关系 表现为新生血管性AMD的特点和严重程度。 (6)评价抗凝药物与视网膜的关系 新生血管性AMD患者的出血情况。 CATT数据集是进一步评估Lucentis和 阿瓦斯丁对视觉和形态变化的影响，以阐明两者之间的联系 视觉和形态反应，并确定因素(遗传和 系统性药物暴露)，这可能与新生血管性AMD的特征有关 演示文稿。对CATT数据集的分析将为 治疗眼科医生和他们的患者从治疗中期待什么，并 帮助监测和优化新生血管性AMD的治疗 医药。非常大的样本量(N=1185)、高质量的数据集以及 调查人员的丰富经验和高生产率以及充分的 CATT研究组的支持，支持的可行性和可能性很高 建议项目的收益率。

Additional Analysis of the Data from the Comparison of Age-related Macular Degeneration Treatments Trials (CATT) (NEI Research Grant for Secondary Data Analysis (R21)) Abstract The proposed project will utilize the comprehensive dataset from the Comparison of Age-related Macular Degeneration (AMD) Treatments Trials (CATT), a multi-center non-inferiority clinical trial, sponsored by the National Eye Institute, to assess the efficacy and safety of ranibizumab (Lucentis) and bevacizumab (Avastin) when treated monthly or PRN (pro re nata). The specific aims of this proposal do not include the major goals of the CATT Study, which were already accomplished. Instead, the proposed project involves additional secondary analysis of the CATT dataset to address the following important new aims: (1) To describe the response pattern of visual acuity over time during the 2 years of treatment, and to determine whether the short-term response of visual acuity (after 1 or 3 injections) predicts the long-term (2 years) visual acuity response. (2) To describe the morphologic changes captured by OCT and fluorescein angiography over time during 2 years of treatment, and to evaluate whether the morphologic responses at 3 months predict the long-term morphologic responses at 2 years. (3) To assess the associations between vision and morphologic changes from anti- VEGF treatment at 2 years. (4) To describe treatment patterns and identify the prognostic factors associated with a low number of treatments in patients treated PRN for 2 years. (5) To assess genotype-phenotype associations with respect to the morphologic features and severity of neovascular AMD at presentation. (6) To evaluate the association of anticoagulation medications with retinal hemorrhage in patients with neovascular AMD. The CATT dataset is a unique resource to further evaluate the effects of Lucentis and Avastin on visual and morphologic changes, to elucidate the association between visual and morphologic responses, and to determine the factors (genetic and systemic drug exposure) that may be associated with features of neovascular AMD at presentation. The analyses of the CATT dataset will provide useful information to the treating ophthalmologists and their patients on what to expect from treatments, and to help monitor and optimize the treatment of the neovascular AMD by personalized medicine. The very large sample size (N=1185), high quality of the dataset, as well as the rich experience and high productivity of the investigators along with the full supports of the CATT Research Group, support the feasibility and likelihood of high yield of the proposed project.