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（CATT）的比较是两项连续的，多个中心的随机临床试验的建议，以比较新血管AMD的治疗方法 - 首先是单一疗法试验，第二次是组合治疗试验。在此Fellus照片阅读中心（FPRC）应用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两个提议的试验的进行实现：1）通过彩色眼底照片和荧光素血管造影识别那些最有可能受益于旨在防止视力丧失的预防策略或治疗方法的眼睛，或者用AMD提高视力敏锐度； 2）通过荧光素血管造影术的资格确定研究入学和治疗有效的何时； 3）为直接比较脉络膜新生血管形成的血管造影特征与眼部相干性断层图捕获的血管造影特征提供了基础。这些目标将通过以下特定目的来实现：具体目标1：建立基础架构来处理CATT临床中心将向FPRC提交的颜色底面照相和荧光素血管造影数字图像。具体目标2：与协调中心合作，为CATT临床研究研究者，诊所协调员和摄影师建立和实施摄影认证和培训计划，以准备Catt。特定目的3：提供可靠，及时，可重复的和系统分级的彩色照片以及CATT的血管造影图像材料。 为了实现这些目标，FPRC开发了用于在CD上提交图像的模块，收到CD并将图像下载到FPRC图像数据库中以及对数字图像进行分级。我们将建立安全的方法将数据从FPRC传输到协调中心。 FPRC还将为分级机，摄影师，诊所协调员和眼科医生认证和培训实施材料和方法，并支持研究目标作为招聘，研究小组会议，演讲和出版物的图像资源。