Intravitreal Corticosteroid for Macular Edema Study

玻璃体内皮质类固醇治疗黄斑水肿研究

• 批准号: 6895738
• 负责人: BARBARA A BLODI
• 金额: $ 23.53万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-01 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6895738
• 关键词: clinical research; clinical trial phase III; comorbidity; diabetic retinopathy; edema; eye disorder chemotherapy; eye disorder diagnosis; eye fundus photography; eye surgery; fluorescein angiography; hormone therapy; human subject; human therapy evaluation; longitudinal human study; optical tomography; outcomes research; patient oriented research; photocoagulation therapy; retina disorder; triamcinolone; vein occlusion

DESCRIPTION (provided by applicant): The University of Wisconsin Fundus Photograph Reading Center (UW FPRC) proposes to serve as photograph reading center for the Intravitreal Corticosteroid for Macular Edema study. To accomplish this, we propose to: 1. Apply current procedures for documenting and grading macular edema. We can provide protocols for macular edema 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 macular edema from color photographs and fluorescein angiograms. We are developing a protocol for assessment of OCT scans. 2. Assist the study chair and study investigators in 1) the conduct of the clinical trial (for example, timely review of photographs and angiograms for eligibility), 2) the analysis of the resultant data and 3) the preparation of manuscripts for publication. The UW FPRC principal investigator and staff are experienced at participation in collaborative multi-center clinical trials and are strongly committed to the study of new treatments for macular edema due to diabetes mellitus and retinal vein occlusion.

描述（由申请人提供）：威斯康星大学眼底照片阅读中心（UW FPRC）拟作为玻璃体内皮质类固醇治疗黄斑水肿研究的照片阅读中心。为了实现这一目标，我们建议： 1. 应用当前的黄斑水肿记录和分级程序。我们可以提供黄斑水肿成像方案（彩色立体眼底照片、荧光素血管造影和光学相干断层扫描），并且在为临床摄影师提供指导、认证和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荧光素血管造影对黄斑水肿进行评估/分级的方案。我们正在开发 OCT 扫描评估协议。 2. 协助研究主席和研究研究者 1) 进行临床试验（例如，及时审查照片和血管造影的资格），2) 分析结果数据，3) 准备出版手稿。 华盛顿大学 FPRC 首席研究员和工作人员在参与合作方面拥有丰富的经验 多中心临床试验，并致力于研究糖尿病和视网膜静脉阻塞引起的黄斑水肿的新疗法。