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

AMD 治疗试验比较数据的二次数据分析

• 批准号: 8568893
• 负责人: Gui-shuang Ying
• 金额: $ 24万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8568893
• 关键词: Address; Age related macular degeneration; Anticoagulation; Avastin; Blindness; Clinical Trials; Data; Data Analyses; Data Set; Decision Making; Drug Exposure; Drug usage; Elderly; Exudative age-related macular degeneration; Eye; Fluorescein Angiography; Funding; Genetic; Genotype; Goals; Growth and Development function; Injection of therapeutic agent; Lead; Legal Blindness; Lesion; Liquid substance; Lucentis; Medicine; Monitor; Morphology; National Eye Institute; Ophthalmologist; Outcome; Paper; Patients; Pattern; Pharmaceutical Preparations; Phenotype; Population; Prevention; Productivity; Prognostic Factor; Publishing; Research; Research Personnel; Resolution; Resources; Retinal; Retinal Hemorrhage; Safety; Sample Size; Severities; Subgroup; Support Groups; Time; Treatment Protocols; Vascular Endothelial Growth Factors; Vision; Visual; Visual Acuity; bevacizumab; clinical care; experience; geographic atrophy; improved; intravitreal injection; public health relevance; ranibizumab; response; treatment duration; treatment trial

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.

对年龄相关比较数据的补充分析 黄斑变性治疗试验 (CATT) （NEI 二次数据分析研究补助金 (R21)) 抽象的 拟议的项目将利用来自比较的综合数据集 年龄相关性黄斑变性 (AMD) 治疗试验 (CATT)，一个多中心 由国家眼科研究所赞助的非劣效性临床试验，旨在评估 雷珠单抗（Lucentis）和贝伐单抗（Avastin）的有效性和安全性 每月治疗或 PRN (pro re nata)。该提案的具体目标不包括 CATT 研究的主要目标已经实现。相反， 拟议的项目涉及对 CATT 数据集进行额外的二次分析 解决以下重要的新目标： (1) 描述 2 年期间视力随时间变化的反应模式 治疗，并确定视力的短期反应（1次后） 或 3 次注射）可预测长期（2 年）视力反应。 (2) 描述OCT和荧光素血管造影捕获的形态变化 在 2 年的治疗过程中，随着时间的推移，并评估形态学是否 3 个月时的反应可预测 2 岁时的长期形态学反应。 (3) 评估视力与抗病毒引起的形态变化之间的关联 2 年时进行 VEGF 治疗。 (4) 描述治疗模式并确定与治疗相关的预后因素 接受 PRN 治疗 2 年的患者治疗次数较少。 (5) 评估形态学方面的基因型-表型关联 就诊时新生血管性 AMD 的特征和严重程度。 (6) 评估抗凝药物与视网膜病变的关系 新生血管性AMD患者的出血。 CATT 数据集是进一步评估 Lucentis 和 阿瓦斯汀对视觉和形态变化的影响，阐明两者之间的关联 视觉和形态反应，并确定因素（遗传和 全身药物暴露）可能与新生血管性 AMD 的特征有关 推介会。 CATT 数据集的分析将为 向眼科医生及其患者介绍治疗的期望，并 通过个性化帮助监测和优化新生血管性 AMD 的治疗 药品。样本量非常大（N=1185），数据集质量高，以及 调查人员的丰富经验和高生产力以及充分的 CATT 研究小组的支持，支持高的可行性和可能性 拟议项目的产量。