Intravitreal Corticosteroid for Macular Edema

玻璃体内注射皮质类固醇治疗黄斑水肿

• 批准号: 7077671
• 负责人: PAUL C VAN VELDHUISEN
• 金额: $ 12.73万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7077671
• 关键词: Adrenal Cortex Hormones; Archives; Blood Pressure; Case Report Form; Clinical; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Communication; Data; Data Coordinating Center; Diabetic Retinopathy; Early treatment; Enrollment; Ensure; Eye; Fluorescein Angiography; Fundus photography; Hemoglobin; Injection of therapeutic agent; Internet; Kidney; Leadership; Letters; Light Coagulation; Lipids; Manuals; Multi-Institutional Clinical Trial; Optical Coherence Tomography; Outcome; Participant; Patient observation; Patients; Phase; Policies; Procedures; Protocols documentation; Quality of life; Randomized; Request for Applications; Research; Research Design; Research Personnel; Retinal Vein Occlusion; Safety; Score; Secondary to; Site; Standards of Weights and Measures; Subgroup; System; Testing; Triamcinolone Acetonide; United States National Institutes of Health; Vision; Visual Acuity; base; central retinal vein occlusion; data management; day; design; diabetic; emotional distress; experience; functional status; human subject; macular edema; prospective; protocol development; stereoscopic; symposium

DESCRIPTION (provided by applicant): The Intravitreal Corticosteroid for Macular Edema (ICME) Study is a multi-center, prospective, randomized, NIH-defined Phase III clinical trial designed to assess the safety and efficacy of intravitreal injection(s) of triamcinolone acetonide in patients with macular edema secondary to diabetic retinopathy, central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) who have failed to respond favorably to focal/grid photocoagulation (diabetic macular edema group and BRVO) or at least 90 days of observation (CRVO). Patients in each of these groups will be randomly assigned to one of the following: 1) conventional treatment (observation or repeat focal/grid photocoagulation for patients with macular edema associated with diabetic retinopathy or BRVO; observation for patients with macular edema associated with CRVO), or 2) treatment with intravitreal injection(s) of triamcinolone acetonide A total of 186 participants in the diabetic retinopathy group and 116 participants in each of the CRVO and BRVO groups will be enrolled at 20-25 clinical centers. Participants will be followed for 24 months, with assessments including Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score, stereoscopic fundus photography, fluorescein angiography and optical coherence tomography performed at baseline and at 3 and/or 6 month intervals through 24 months. The primary outcome is a 10 letter or more improvement in ETDRS visual acuity assessed at 24 months. This application is to establish a Data Coordinating Center (DCC) that will provide the leadership and collaboration required to successfully implement the ICME study. As the DCC, The EMMES Corporation will be involved in all aspects of the ICME study design and management, which includes protocol development and implementation, developing data management systems, ensuring protection of human subjects, providing support to a Data and Safety Monitoring Board for study oversight, and providing statistical support for the dissemination of study results. EMMES has a broad base of experience in coordinating multi-center clinical trials and we are confident of our ability to coordinate the ICME study according to the hi hest standards of NIH-sponsored research.

描述（由申请人提供）：玻璃体内皮质类固醇治疗黄斑水肿（ICME）研究是一项多中心、前瞻性、随机、nih定义的III期临床试验，旨在评估玻璃体内注射曲安奈德治疗继发于糖尿病视网膜病变的黄斑水肿患者的安全性和有效性。视网膜中央静脉闭塞（CRVO）或视网膜分支静脉闭塞（BRVO），对局灶/网格光凝治疗（糖尿病黄斑水肿组和BRVO）或至少90天观察（CRVO）无效。每组的患者将被随机分配到以下一组：