NAC Attack, a phase-3, multicenter, randomized, placebo-controlled trial with retinitis pigmentosa: OCT Reading Center

摘要 本申请中提出的活动的目标是提供光谱域光学 相干断层扫描(SD-OCT)阅读中心对NAC攻击研究的支持。这个项目的 主要目标是通过OCT确定N-乙酰半胱氨酸(NAC)与对照的效果 从基线到研究结束时视网膜色素变性进展的治疗，根据 中心凹中心椭球区(EZ)长度的累积损失。探索性的目标是确定 与对照相比，NAC对EZ区域累积损失的影响。 主要和探索性目标将通过以下具体目标实现： 具体目标1：提供处理NAC攻击提交的SD-OCT图像的基础设施 临床站点到华侨城阅读中心。 具体目标2：培训和认证NAC攻击临床现场人员，了解获取和 将图像传输到OCT阅读中心。 具体目标3：提供可靠、及时、可重现和系统的提交评级 SD-OCT 为了实现这些目标，我们将使用内部开发、验证和符合21 CFR 21的 独立的基于Web的系统，为临床站点传输电子信息提供安全方法 SD-OCT数据到OCT阅读中心，要存储和备份提交的数据，请分配 将图像分级到阅读器，并提供电子数据输入表格，供阅读器使用 将输入他们的图像质量评估数据。读者将使用我们的定制开发和 经过验证的软件可以手动分级中心凹EZ长度并自动量化EZ面积 在指定的图像中。中心凹EZ长度和EZ面积数据将直接从 软件到数据库中，该数据库将通过安全的 传送门。华侨城阅读中心还将为读者和 临床现场OCT技师认证和培训，严格的手动和 自动评分，并支持学习目标作为招聘的图像资源，学习小组 会议、演示文稿和出版物。

Abstract The objective of the activities proposed in this application is to provide spectral-domain optical coherence tomography (SD-OCT) Reading Center support to the NAC Attack study. This project's primary goal is to identify by OCT the effect of N-acetyl cysteine (NAC) compared to control treatment on progression of retinitis pigmentosa from baseline to study end, as assessed by the cumulative loss in foveal-centered ellipsoid zone (EZ) length. An exploratory goal is to determine NAC's effect, when compared to control, on the cumulative loss of the EZ area. The primary and exploratory objectives will be accomplished through the following specific aims: Specific Aim 1: Provide the infrastructure to process SD-OCT images submitted by NAC Attack clinical sites to the OCT Reading Center. Specific Aim 2: Train and certify NAC Attack clinical site personnel on methods to acquire and transmit images to the OCT Reading Center. Specific Aim 3: Provide Reliable, Timely, Reproducible, and Systematic Grading of submitted SD-OCT. To achieve these aims, we will use in-house developed, validated, and 21 CFR 21-compliant stand-alone web-based systems to provide secure methods for clinical sites to transmit electronic SD-OCT data to the OCT Reading Center, to store and back-up submitted data, assign the images to be graded to Reader, and to provide electronic data entry forms into which Readers will enter their image quality assessment data. Readers will use our custom-developed and validated software to manually grade the foveal EZ length and automatically quantify the EZ area in the assigned images. The foveal EZ length and EZ area data will be exported directly from software into a database that will be transferred to the Coordinating Center through a secure portal. The OCT Reading Center will also implement materials and methods for Reader and clinical site OCT technician certification and training, rigorous quality control for manual and automatic gradings, and support study goals as an image resource for recruitment, Study Group meetings, presentations, and publications.