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: 8725165
• 负责人: Gui-shuang Ying
• 金额: $ 19.6万
• 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 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8725165
• 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

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：拟议项目将利用年龄相关性黄斑变性（AMD）治疗试验比较（CATT）的综合数据集，这是一项多中心非劣效性临床试验，由国家眼科研究所赞助，到 评估雷珠单抗 (Lucentis) 和贝伐单抗 (Avastin) 每月治疗或 PRN (pro re nata) 的疗效和安全性。本提案的具体目标不包括已经实现的 CATT 研究的主要目标。相反，拟议的项目涉及对 CATT 数据集进行额外的二次分析，以实现以下重要的新目标：（1）描述 2 年治疗期间视敏度随时间的反应模式，并确定短期反应是否有效视力（1 或 3 次注射后）可预测长期（2 年）视力反应。 (2) 描述治疗 2 年期间 OCT 和荧光素血管造影随时间推移捕获的形态学变化，并评估 3 个月时的形态学反应是否可预测 2 年时的长期形态学反应。 (3) 评估 2 年抗 VEGF 治疗后视力与形态变化之间的关联。 (4) 描述治疗模式并确定与接受 PRN 治疗 2 年的患者治疗次数少相关的预后因素。 (5) 评估基因型-表型与新生血管性 AMD 的形态特征和严重程度之间的关联。 (6) 评估新生血管性AMD患者抗凝药物与视网膜出血的关系。 CATT 数据集是一个独特的资源，可进一步评估 Lucentis 和 Avastin 对视觉和形态变化的影响，阐明视觉和形态反应之间的关联，并确定可能与特征相关的因素（遗传和全身药物暴露）就诊时患有新生血管性 AMD。 CATT 数据集的分析将为治疗眼科医生及其患者提供有关治疗预期的有用信息，并帮助通过个性化医疗监测和优化新生血管性 AMD 的治疗。非常大的样本量（N=1185）、高质量的数据集、研究人员丰富的经验和高生产力以及CATT研究组的全力支持，支持了高的可行性和可能性。 拟议项目的产量。

项目成果

Association between Antiplatelet or Anticoagulant Drugs and Retinal or Subretinal Hemorrhage in the Comparison of Age-Related Macular Degeneration Treatments Trials.

• DOI: 10.1016/j.ophtha.2015.09.046
• 发表时间: 2016-02
• 期刊: Ophthalmology
• 影响因子: 13.7
• 作者: Ying GS;Maguire MG;Daniel E;Grunwald JE;Ahmed O;Martin DF;Comparison of Age-Related Macular Degeneration Treatments Trials Research Group
• 通讯作者: Comparison of Age-Related Macular Degeneration Treatments Trials Research Group