Photograph Reading Center for the Comparison of AMD Treatment Trials

描述（由申请人提供）：AMD治疗试验的比较（CATT）是两个连续的、多中心的、随机的临床试验来比较新血管性AMD的治疗方法，第一个是单一治疗试验，第二个是联合治疗试验。眼底照片阅读中心（FPRC）申请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进行两项拟议试验来实现：1)通过眼底彩色照片和荧光素血管造影来确定那些最有可能从预防策略或治疗中受益的眼睛，这些策略或治疗旨在防止视力丧失，或改善患有AMD的眼睛的视力；2)通过荧光素血管造影确定纳入研究的资格和治疗的有效时间；3)为直接比较脉络膜新生血管的血管造影特征与眼相干层析成像特征提供依据。这些目标将通过以下具体目标实现：具体目标1：建立处理彩色眼底摄影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FPRC。具体目标2：与协调中心合作，建立和实施CATT临床研究调查员、临床协调员和摄影师的摄影认证和培训计划，为CATT做准备。具体目标3：为CATT提供可靠、及时、可复制和系统的彩色照片照片和血管造影图像材料分级。为达致上述目标，影像资料中心已开发了若干模块，供提交影像光碟、接收影像光碟及将影像下载至影像资料中心的影像资料库，以及对数码影像进行分级。我们将建立从FPRC向协调中心传输数据的安全方法。FPRC还将实施评分员、摄影师、诊所协调员和眼科医生认证和培训的材料和方法，并作为招聘、研究小组会议、演讲和出版物的图像资源支持研究目标。

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.