Photograph Reading Center for the Comparison of AMD Treatment Trials

AMD 治疗试验比较照片阅读中心

• 批准号: 7172529
• 负责人: JUAN E GRUNWALD
• 金额: $ 48.79万
• 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 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7172529
• 关键词: angiogenesis; clinical research; clinical trials; combination therapy; digital imaging; eye; fluoresceins; information systems; reading; training

DESCRIPTION (provided by applicant): The Comparison of AMD Treatment Trials (CATT) is a proposal of two consecutive, multi-centered, randomized clinical trials to compare treatments for neovascular AMD-the first a monotherapy trial, and the second a combination therapy trial. The primary objective of the activities proposed in this Fundus Photograph Reading Center (FPRC) application is to provide support to the CATT. The long term goals of this project, that will be accomplished through the conduct of the two proposed trials are: 1) to identify by color fundus photographs and fluorescein angiograms those eyes that are most likely to benefit from preventative strategies or treatments designed to prevent vision loss, or improve visual acuity in eyes with AMD; 2) to determine by fluorescein angiography eligibility for study enrollment and when treatment is effective; and 3) to provide a basis for direct comparison between angiographic characteristics of choroidal neovascularization and those captured by ocular coherence tomograms. These goals will be accomplished via the following specific aims: Specific Aim 1: Establish the infrastructure to process color fundus photographic and fluorescein angiographic digital images that will be submitted by CATT clinical centers to the FPRC. Specific Aim 2: Collaborate with the Coordinating Center to establish and implement photographic certification and training programs for CATT clinical study investigators, clinic coordinators, and photographers in preparation of CATT. Specific Aim 3: Provide reliable, timely, reproducible, and systematic grading of submitted color photograph photographs and angiographic image materials for CATT. To achieve these aims, the FPRC has developed modules for submission of images on CD's, receipt of CD's and downloading of images to the FPRC image data base, and for grading digital images. We will establish secure methods to transmit data from the FPRC to the Coordinating Center. The FPRC also will implement materials and methods for grader, photographer, clinic coordinator, and ophthalmologist certification and training, and support study goals as an image resource for recruitment, Study Group meetings, presentations and publications.

描述(由申请人提供)：AMD治疗试验比较(CATT)是两个连续的、多中心的、随机的临床试验，以比较新生血管性AMD的治疗方法--第一个是单一疗法试验，第二个是联合疗法试验。Fundus照片阅读中心(FPRC)应用程序中提出的活动的主要目标是为CATT提供支持。该项目的长期目标将通过实施两项拟议的试验来实现：1)通过彩色眼底照片和荧光素血管造影确定最有可能受益于旨在防止视力损失或提高AMD患者视力的预防性策略或治疗方法的眼睛；2)通过荧光素血管成像确定是否有资格参加研究以及何时治疗有效；以及3)为脉络膜新生血管的血管成像特征与眼部相干断层扫描所捕捉到的特征进行直接比较提供基础。这些目标将通过以下具体目标来实现：具体目标1：建立处理彩色眼底照相和荧光素血管造影数字图像的基础设施，这些图像将由CATT临床中心提交给临床研究中心。具体目标2：与协调中心合作，为CATT临床研究研究员、临床协调员和摄影师建立和实施照相认证和培训计划，以准备CATT。具体目标3：为CAT提供可靠、及时、可重现和系统的彩色照片和血管造影影像资料分级。为实现这些目标，方案和协调中心开发了用于提交光盘图像、接收光盘和将图像下载到方案方案图像数据库以及对数字图像进行分级的模块。我们将建立安全的方法，将数据从FPRC传输到协调中心。研究中心还将为评分员、摄影师、临床协调员、眼科医生认证和培训提供材料和方法，并支持研究目标作为招募、研究小组会议、演示和出版物的图像资源。