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

NAC Attack，一项针对色素性视网膜炎的 3 期、多中心、随机、安慰剂对照试验：OCT 阅读中心

基本信息

批准号：
10333125
负责人：
Sina Farsiu
金额：
$ 21.39万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-17 至 2027-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10333125
关键词：
Acetylcysteine Archives Area Back Biological Markers Blindness Certification Characteristics Clinical Clinical Trials Collaborations Computer software Custom Cysteine Data Databases Disease Disease Progression Ensure Eye Goals Group Meetings Health Human Resources Image Infrastructure Inherited Length Manuals Measures Methods Modernization Online Systems Optical Coherence Tomography Phase Photoreceptors Placebos Process Protocols documentation Public Health Publications Quality Control Reader Reading Reproducibility Research Personnel Resources Retina Retinal Diseases Retinitis Pigmentosa Scanning Secure Site Standardization System Testing Time Training Width adaptive optics clinical research site cost data exchange deep learning algorithm design electronic data imaging modality novel programs randomized placebo controlled trial recruit retinal imaging social software development software systems time use transmission process

项目摘要

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.

抽象的本申请中提出的活动的目标是提供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) 与对照相比的效果治疗对色素性视网膜炎从基线到研究结束进展的影响，由以中心凹为中心的椭球区（EZ）长度的累积损失。探索性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来实现：具体目标 1：提供基础设施来处理 NAC Attack 提交的 SD-OCT 图像 OCT 阅读中心的临床站点。具体目标 2：对 NAC Attack 临床现场人员进行培训和认证，了解获取和将图像传输至 OCT 阅片中心。具体目标 3：对提交的内容提供可靠、及时、可重复和系统的评分 SD-OCT。为了实现这些目标，我们将使用内部开发、经过验证且符合 21 CFR 21 的基于网络的独立系统，为临床站点传输电子数据提供安全方法 SD-OCT数据发送至OCT阅片中心，对提交的数据进行存储和备份，分配图像将被分级给读者，并提供电子数据输入表格供读者输入将输入他们的图像质量评估数据。读者将使用我们定制开发的和经过验证的软件可手动对中心凹 EZ 长度进行分级并自动量化 EZ 面积在指定的图像中。中央凹 EZ 长度和 EZ 面积数据将直接从软件存入数据库，该数据库将通过安全的方式传输到协调中心门户网站。 OCT阅读中心还将实施读者和读者的材料和方法。临床现场OCT技术人员认证和培训，严格的手册和质量控制自动评分，并支持学习目标作为招聘的图像资源，Study Group 会议、演示和出版物。