Coordinating Center for the Comparison of AMD Treatments Trial

AMD 治疗试验比较协调中心

• 批准号: 8213503
• 负责人: MAUREEN G MAGUIRE
• 金额: $ 81.75万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8213503
• 关键词: Accounting; Age related macular degeneration; Ancillary Study; Avastin; Blindness; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Communication; Country; Data; Data Analyses; Data Collection; Databases; Disease; Effectiveness; Funding; Fundus; Future; Goals; Instruction; Lead; Leadership; Lucentis; Maintenance; Monitor; Patients; Performance; Pharmaceutical Preparations; Preparation; Protocols documentation; Randomized Clinical Trials; Reading; Relative (related person); Reporting; Research Design; Role; Safety; System; United States; Vision; Work; alternative treatment; clinical research site; data management; design; meetings; member; neovascular; primary outcome; programs; quality assurance; secondary outcome; success; treatment trial

DESCRIPTION (provided by applicant): Age-related macular degeneration (AMD) is the leading cause of blindness in the United States and most western countries. The Comparison of AMD Treatments Trials (CATT) is a large-scale (1200 patient), randomized clinical trial designed to evaluate the relative efficacy and safety of alternative treatments for the neovascular form of the disease that accounts for approximately 90% of blindness due to AMD. We now request funding to complete the clinical trial and to follow the patients through 5 years to obtain long-term data on safety and vision. The goal of the Coordinating Center is to contribute to the success of the CATT by providing study leadership, data management, data analysis, and communication, by facilitating the execution of the study protocol, and by coordinating the activities of the study group. The Coordinating Center provides expertise on design of multicenter clinical studies, implementation and maintenance of high quality data management systems, statistical analysis, and quality assurance in data management and clinical center performance. The specific aims of the Coordinating Center to fulfill this role are: 7 Work with the other members of the study group to further refine the study design; 7 Create and maintain the study database through design of data collection forms, data capture, data editing, and data management; Provide timely, regular reports concerning study progress and performance to the clinical sites, OCT Reading Center, Fundus Photograph Reading Center, Executive Committee and its subcommittees, and the Data and Safety Monitoring Committee; 7 Design and implement a full program of quality assurance activities, in conjunction with the Executive Committee; Provide interim and final statistical analysis of the accumulated data on primary and secondary outcomes, as well as ancillary studies; Contribute to and distribute support materials for all CATT meetings; Participate and lead in the preparation of scientific presentations and reports. 7 Administer subcontracts with CATT clinical centers; RELEVANCE (See instructions): Age-related macular degeneration (AMD) is the leading cause of blindness in the United States and most western countries. These studies of the relative effectiveness and safety of the two drugs under study will determine how patients with neovascular ("wet") AMD are treated in the future.

描述（由申请人提供）：与年龄相关的黄斑变性（AMD）是美国和大多数西方国家失明的主要原因。 AMD治疗试验（CATT）的比较是一项大规模（1200名患者），随机临床试验，旨在评估疾病新生血管形式的替代治疗的相对功效和安全性，占AMD引起的盲目性的90％。现在，我们要求资金完成临床试验，并跟踪患者5年以获取有关安全和视力的长期数据。 协调中心的目的是通过促进研究协议的执行以及协调研究小组的活动，通过提供研究领导，数据管理，数据分析和沟通来为CATT的成功做出贡献。协调中心提供了有关多中心临床研究，高质量数据管理系统的实施和维护，统计分析以及数据管理和临床中心绩效质量保证的专业知识。 协调中心履行此角色的具体目的是：7与研究小组的其他成员合作，进一步完善研究设计； 7通过设计数据收集表，数据捕获，数据编辑和数据管理来创建和维护研究数据库； 及时提供有关研究进度和绩效的定期报告，向临床站点，OCT阅读中心，眼底照片阅读中心，执行委员会及其小组委员会以及数据与安全监测委员会； 7与执行委员会一起设计和实施完整的质量保证活动计划； 提供有关主要和次要结果以及辅助研究的累积数据的临时和最终统计分析； 为所有CATT会议贡献并分发支持材料； 参与并领导科学演示和报告的准备。 7管理CATT临床中心的分包合同；相关性（请参阅说明）：与年龄相关的黄斑变性（AMD）是美国和大多数西方国家失明的主要原因。这些研究中两种正在研究的药物的相对有效性和安全性的研究将决定新血管（“湿”）AMD的患者将来如何治疗。

项目成果

Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results.

• DOI: 10.1016/j.ophtha.2012.03.053
• 发表时间: 2012-07
• 期刊: Ophthalmology
• 影响因子: 13.7
• 作者: Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group;Martin DF;Maguire MG;Fine SL;Ying GS;Jaffe GJ;Grunwald JE;Toth C;Redford M;Ferris FL 3rd
• 通讯作者: Ferris FL 3rd

Macular morphology and visual acuity in the comparison of age-related macular degeneration treatments trials.

• DOI: 10.1016/j.ophtha.2013.01.073
• 发表时间: 2013-09
• 期刊: Ophthalmology
• 影响因子: 13.7
• 作者: Jaffe GJ;Martin DF;Toth CA;Daniel E;Maguire MG;Ying GS;Grunwald JE;Huang J;Comparison of Age-related Macular Degeneration Treatments Trials Research Group
• 通讯作者: Comparison of Age-related Macular Degeneration Treatments Trials Research Group

Outcomes in Eyes with Retinal Angiomatous Proliferation in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT).

• DOI: 10.1016/j.ophtha.2015.10.034
• 发表时间: 2016-03
• 期刊: Ophthalmology
• 影响因子: 13.7
• 作者: Daniel E;Shaffer J;Ying GS;Grunwald JE;Martin DF;Jaffe GJ;Maguire MG;Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group
• 通讯作者: Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group

Growth of geographic atrophy in the comparison of age-related macular degeneration treatments trials.

• DOI: 10.1016/j.ophtha.2014.11.007
• 发表时间: 2015-04
• 期刊: OPHTHALMOLOGY
• 影响因子: 13.7
• 作者: Grunwald, Juan E.;Pistilli, Maxwell;Ying, Gui-shuang;Maguire, Maureen G.;Daniel, Ebenezer;Martin, Daniel F.
• 通讯作者: Martin, Daniel F.

Baseline predictors for one-year visual outcomes with ranibizumab or bevacizumab for neovascular age-related macular degeneration.

• DOI: 10.1016/j.ophtha.2012.07.042
• 发表时间: 2013-01
• 期刊: Ophthalmology
• 影响因子: 13.7
• 作者: Ying GS;Huang J;Maguire MG;Jaffe GJ;Grunwald JE;Toth C;Daniel E;Klein M;Pieramici D;Wells J;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