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.

对来自与其他药物相关的比较的数据的附加分析 黄斑变性治疗试验（CATT） (NEI二级数据分析研究补助金 （R21）） 摘要 拟议的项目将利用来自比较的综合数据集， 视网膜相关黄斑变性（AMD）治疗试验（CATT），一项多中心 非劣效性临床试验，由国家眼科研究所赞助，以评估 雷珠单抗（Lucentis）和贝伐单抗（Avastin）的疗效和安全性， 每月治疗一次或PRN（亲自然）。本提案的具体目标不包括 CATT研究的主要目标已经实现。而是 拟议项目涉及CATT数据集的额外二次分析， 实现以下重要的新目标： (1)描述2年内随时间变化的视力反应模式， 治疗，并确定是否短期反应的视力（后1 或3次注射）预测长期（2年）视敏度反应。 (2)描述OCT和荧光素血管造影捕获的形态学变化 随着时间的推移，在2年的治疗，并评估是否形态 3个月时的反应预测2年时的长期形态学反应。 (3)评估视力与抗- VEGF治疗2年。 (4)描述治疗模式，并确定预后相关因素， 接受PRN治疗2年的患者治疗次数较少。 (5)评估基因型-表型相关性， 表现时新生血管性AMD的特征和严重程度。 (6)评价抗凝药物与视网膜病变的相关性， 新生血管性AMD患者出血。 CATT数据集是进一步评估Lucentis效果的独特资源， Avastin对视觉和形态学变化的影响，以阐明 视觉和形态反应，并确定因素（遗传和 全身性药物暴露），可能与新生血管性AMD的特征相关， 演示文稿. CATT数据集的分析将为 治疗眼科医生和他们的病人对治疗的期望， 帮助监测和优化治疗的新生血管性AMD的个性化 药非常大的样本量（N=1185），高质量的数据集，以及 沿着的调查人员经验丰富、工作效率高， CATT研究小组的支持，支持高的可行性和可能性， 建议项目的收益率。