Intravitreal Corticosteroid for Macular Edema

描述(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(S)对继发于糖尿病视网膜病变、视网膜中央静脉阻塞或视网膜分支静脉阻塞继发于黄斑水肿的患者的安全性和有效性，这些患者对焦点/网格光凝(糖尿病黄斑水肿组和BRVO)或至少观察90天无效。这些组中的每一组的患者将被随机分配到以下组之一： 1)常规治疗(观察或重复局部/栅格光凝治疗 与糖尿病视网膜病变或BRVO相关的黄斑水肿；观察 与CRVO相关的黄斑水肿)，或 2)玻璃体内注射曲安奈德(S)治疗 糖尿病视网膜病变组共有186名参与者，CRVO和BRVO组各有116名参与者将在20-25个临床中心登记。参与者将被跟踪24个月，评估包括早期治疗糖尿病视网膜病变研究(ETDRS)视力评分，立体眼底照相，荧光素血管造影和光学相干断层扫描在基线和3个月和/或6个月至24个月之间进行。主要结果是在24个月时评估的ETDRS视力改善了10个字母或更多。 这项申请旨在建立一个数据协调中心(DCC)，以提供成功实施ICME研究所需的领导和协作。作为DCC，Emmes公司将参与ICME研究设计和管理的所有方面，包括制定和执行方案、开发数据管理系统、确保对人体受试者的保护、支持数据和安全监测委员会进行研究监督，以及为研究结果的传播提供统计支持。Emmes在协调多中心临床试验方面拥有广泛的经验基础，我们相信我们有能力根据NIH赞助的研究的最高标准协调ICME研究。

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.