Comparison of AMD Treatment Trials-OCT Reading Center

AMD治疗试验比较-OCT阅片中心

基本信息

批准号：
8264343
负责人：
GLENN JAFFE
金额：
$ 17.78万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-30 至 2013-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8264343
关键词：
Affect Age related macular degeneration Anatomy Angiography Archives Area Atrophic Back Blindness Certification Characteristics Clinical Clinical Investigator Clinical Research Clinical Trials Color Complex Computer software Custom Data Electronics Ensure Exudative age-related macular degeneration Eye Fluorescein Funding Fundus Fundus photography Goals Group Meetings Housing Human Resources Image Instruction Internet Lesion Long-Term Effects Measurement Medicare Methods Monitor Morphology Online Systems Ophthalmologist Optical Coherence Tomography Optics Outcome Patients Pharmaceutical Preparations Phase Process Protocols documentation Publications Randomized Clinical Trials Reader Reading Relative (related person)Reproducibility Research Infrastructure Research Personnel Resolution Resources Retinal Safety Scanning Secure Site Speed System Thick Time Training Vascular Endothelial Growth Factors Visual Visual Acuity base design follow-up improved macular edema prevent programs therapy design transmission process treatment trial web site

项目摘要

The primary objective ofthe activities proposed in this appHcation is to provide optical coherence tomography (OCT) Reading Center support to the Comparison of Age Related Macular Degeneration Treatment trial (CATT) duringthe conclusion of the CATT rsndomized clinical trial phase, and for the subsequent 3-year follow-up phase. The long term goals of this project, that will be accomplished through conduct of CATT are 1) to identify by OCT those eyes that are most likely to benefit from treatment in eyes with AMD, 2) to determine by OCT when treatment is effective or re-treatment is required and 3) to standardize OCT protocols and grading methods in eyes with AMD. 4) To determine OCT parameters that reflect long-term safety and efficacy ofAMD treatment as administered in CATT. The primary objective will be accomplished through the following specific aims: SPECIFIC AIM 1: Provide the infrastructure to process OCT images that will be submitted by CATT study sites to the CATT OCT Reading Center during the remainder of the randomized clinical trial and follow-up phase SPECIFIC AIM 2: Certify and train CATT study personnel during the remainder of the randomized clinical trial and follow-up phase. SPECIFIC AIM 3: Provide Reliable, Timely, Reproducible, and Systematic Grading of Submitted OCT Material during the remainder ofthe clinical trial and follow-up phase. To achieve these aims, The OCT Reading Center will use a custom, stand-alone web-based system that we have developed to establish and implement secure methods for electronic time-domain and spectral-domain OCT data submission from the CATT clinical study sites to the CATT OCT Reading Center, and to store and back-up submitted data. We will use secure methods to transmit data from the OCT Reading Center to the Coordinating Center. We will develop custom software to quantify retinal and sub-retinal lesion area to monitor thickness changes over time. The Reading Center will also implement materials and methods for reader, OCT technician, clinical coordinator and ophthalmologist certification training, and will support study goals as an image resource for recruitment. Study Group meetings, presentations and pulications. RELEVANCE (See instructions); The funds requested in this application will allow successful completion of the randomiszed clinical trial phase of CATT, and will provide critical safety and efficacy information during the follow-up phase. Results from this trial, which will affect hundreds of thousands of patients with neovascular age-related macular degeneration, will provide the basis for doctors and patients to choose between two different drugs and treatment nians DeDendina on the results. Medicare could save more than $1 billion per vear.

本应用中提出的活动的主要目标是提供光学相干断层扫描 (OCT) 阅读中心对年龄相关性黄斑变性治疗比较试验 (CATT) 的支持在 CATT 随机化临床试验阶段结束期间以及随后的 3 年随访中阶段。通过 CATT 的实施，该项目的长期目标是： 1) 确定通过 OCT 确定最有可能受益于 AMD 眼睛治疗的眼睛，2) 通过 OCT 确定何时治疗有效或需要重新治疗，3) 标准化 OCT 方案和分级方法眼睛有AMD。 4) 确定反映AMD治疗长期安全性和有效性的OCT参数在 CATT 中管理。主要目标将通过以下具体目标来实现：具体目标 1：提供基础设施来处理 OCT 图像，这些图像将由 CATT 研究中心提交给在随机临床试验和随访阶段的剩余时间内，CATT OCT 阅读中心具体目标 2：在随机临床试验的剩余时间内对 CATT 研究人员进行认证和培训和后续阶段。具体目标 3：对提交的 OCT 材料提供可靠、及时、可重复和系统的分级在临床试验的剩余时间和随访阶段。为了实现这些目标，OCT 阅读中心将使用我们拥有的定制、独立的基于网络的系统开发用于建立和实施电子时域和谱域 OCT 数据的安全方法 CATT临床研究中心提交至CATT OCT阅片中心，并进行存储和备份提交的数据。我们将使用安全的方法将数据从 OCT 阅片中心传输到协调中心中心。我们将开发定制软件来量化视网膜和视网膜下病变区域以监测厚度随着时间的推移而变化。阅读中心还将为读者、OCT技术人员、临床协调员和眼科医生认证培训，并将作为图像资源支持研究目标用于招聘。研究组会议、演示和出版物。相关性（参见说明）；本申请中请求的资金将允许成功完成随机临床试验 CATT 阶段，并将在后续阶段提供关键的安全性和有效性信息。结果从这项试验来看，这将影响数十万患有新生血管性年龄相关性黄斑的患者变性，将为医生和患者在两种不同药物之间进行选择提供依据治疗nians DeDendina 对结果的影响。医疗保险每年可以节省超过 10 亿美元。