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）建议用作玻璃体内皮质类固醇的照片阅读中心，用于黄斑水肿研究。为此，我们建议： 1。应用当前程序记录和分级黄斑水肿。我们可以为黄斑水肿成像提供方案（颜色立体底面照片，荧光素血管造影和光学相干性断层图），并在定向，认证和向诊所摄影师提供反馈方面经验丰富。通过扩展早期治疗糖尿病性视网膜病研究分类，我们可以使用彩色照片和荧光素血管造影的黄斑水肿评估/分级的方案。我们正在开发评估OCT扫描的协议。 2。协助研究主席和研究研究人员进行1）临床试验的进行（例如，及时审查照片和血管造影以获得资格），2）对所得数据的分析和3）3）手稿准备出版。 UW FPRC首席研究员和工作人员参与合作 多中心临床试验，由于糖尿病和视网膜静脉闭塞而非常致力于研究黄斑水肿的新治疗方法。