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

• 批准号: 10593932
• 负责人: Sina Farsiu
• 金额: $ 25.53万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 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/10593932
• 关键词: Acetylcysteine; Archives; Area; Biological Markers; Blindness; Certification; Characteristics; Clinical; Clinical Trials; Collaborations; Computer software; Custom; Cysteine; Data; Databases; Disease; Disease Progression; Electronics; Ensure; Eye; Goals; Group Meetings; Health; Human Resources; Image; Infrastructure; Inherited; Length; Manuals; Measures; Methods; Modernization; 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; Software Validation; Standardization; System; Testing; Time; Training; Width; adaptive optics; clinical research site; comparison control; cost; data exchange; data submission; 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; web platform

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.

摘要 本申请中提出的活动的目的是提供光谱域光学测量。 相干断层扫描（SD-OCT）阅读中心支持NAC发作研究。此项目的 主要目的是通过OCT鉴定N-乙酰半胱氨酸（NAC）与对照组相比的作用 治疗对视网膜色素变性从基线到研究结束的进展的影响，如由 以中心凹为中心的椭圆体区（EZ）长度的累积损失。一个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 Attack提交的SD-OCT图像的基础设施 OCT阅读中心。 具体目标2：培训和认证NAC Attack临床研究中心人员获取和 将图像传输至OCT阅读中心。 具体目标3：提供可靠、及时、可复制和系统的提交评级 SD-OCT。 为了实现这些目标，我们将使用内部开发的，经过验证的，符合21 CFR 21的 独立的基于网络的系统，为临床研究中心提供安全的方法， 将SD-OCT数据发送到OCT阅读中心，以存储和备份提交的数据，分配 图像将被分级到阅读器，并提供电子数据输入表格，阅读器 将输入其图像质量评估数据。读者将使用我们的定制开发和 经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 将软件输入数据库，通过安全的 portal.华侨城阅读中心还将为读者提供材料和方法， 临床研究中心OCT技术员认证和培训，严格的手册和 自动评分，并支持研究目标，作为招聘的图像资源，研究组 会议、演讲和出版物。