Diabetic Retinopathy Clinical Research Network

糖尿病视网膜病变临床研究网络

基本信息

批准号：
7221205
负责人：
Ronald Danis
金额：
$ 40.94万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-30 至 2008-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7221205
关键词：
Acquired Immunodeficiency Syndrome Angiography Area Certification Classification Clinic Clinical Research Clinical Treatment Clinical Trials Color Commit Data Data Analyses Diabetes Mellitus Diabetic Retinopathy Early treatment Edema Eligibility Determination Evaluation Feedback Film Fluorescein Fluoresceins Fundus Fundus photography Goals Hand Health Priorities Healthy People 2010 Image Manuscripts Multi-Institutional Clinical Trial Needs Assessment Numbers Ophthalmologist Optics Outcome Pharmaceutical Preparations Pharmacologic Substance Pharmacotherapy Policies Principal Investigator Procedures Protocols documentation Public Health Reading Reporting Research Design Research Personnel Scanning Telephone Tomogram United States Public Health Service Universities Wisconsin Work base caN protocol day diabetic digital experience macula stereoscopic

项目摘要

DESCRIPTION (provided by applicant): The University of Wisconsin Fundus Photograph Reading Center (UW FPRC) proposes to serve as photograph reading center for the DME Clinical Research Network. To accomplish this, we propose to: (I) Collaborate with other network investigators to develop ideas for clinical trials of promising new DME treatments, construct study protocols, carry out approved studies, analyze the resultant data, and prepare manuscripts. (2) Adapt or develop procedures for documenting and grading DME. We can provide protocols for DME imaging (color stereoscopic fundus photographs, fluorescein angiograms, and optical coherence tomograms), and are experienced at orienting, certifying, and giving feedback to clinic photographers. By extending the Early Treatment Diabetic Retinopathy Study classification, we have protocols for evaluation/grading of DME from color photographs and angiograms. We are developing a protocol for assessment of OCT scans. We are prepared to modify these protocols further, if necessary, to define the eligibility and outcome criteria appropriate to network goals. The UW FPRC principal investigator and staff are experienced at participation in collaborative multi-center clinical trials (e.g., Diabetic Retinopathy Study, Early Treatment of Diabetic Retinopathy Study, Diabetes Control and Complications Trial, and several drug trials) and in networks to conduct them (e.g., the Study of the Ocular Complications of AIDS), and are strongly committed to the study of DME and its potential treatments as a major public health priority.

描述（由申请人提供）：威斯康星大学眼底照片阅读中心 (UW FPRC) 提议作为 DME 临床研究网络的照片阅读中心。为了实现这一目标，我们建议： (I) 与其他网络研究人员合作，为有前景的新 DME 治疗方法的临床试验开发想法，制定研究方案，开展经批准的研究，分析结果数据并准备手稿。 (2) 调整或制定 DME 记录和分级程序。我们可以提供 DME 成像方案（彩色立体眼底照片、荧光素血管造影和光学相干断层扫描），并且在指导、认证和向临床摄影师提供反馈方面拥有丰富的经验。通过扩展早期治疗糖尿病视网膜病变研究分类，我们制定了根据彩色照片和血管造影对 DME 进行评估/分级的方案。我们正在开发 OCT 扫描评估协议。如有必要，我们准备进一步修改这些协议，以定义适合网络目标的资格和结果标准。华盛顿大学 FPRC 首席研究员和工作人员在参与协作多中心临床试验（例如，糖尿病视网膜病变研究、糖尿病视网膜病变早期治疗研究、糖尿病控制和并发症试验以及多项药物试验）以及开展这些试验的网络方面拥有丰富的经验（例如，艾滋病眼部并发症的研究），并坚定致力于将 DME 及其潜在治疗方法作为主要公共卫生优先事项进行研究。