Diabetic Retinopathy Clinical Research Network

描述(申请人提供)：糖尿病黄斑水肿(DME)仍然是糖尿病患者视力丧失的主要原因。对这种情况的了解不断增加，促使人们研究治疗DME的新疗法，其中几种正在接近临床试验评估。尽管治疗方法可能差异很大，但在设计、实施和分析高质量临床试验时需要仔细考虑的基本组成部分往往是相似的。此外，具有特定视网膜病变试验专业知识和经验的研究站点是各种此类试验的极好资源。这项建议的目标是建立一个临床试验网络，以评估治疗糖尿病黄斑水肿的新疗法，这些疗法可能比目前标准的激光光凝更有效、更耐受或更容易实施。这一计划将利用一个专门设计的框架，以提供加速的临床研究、标准化的治疗方案、利用多个中心的招募能力和最佳资源利用。这些好处将通过专门的疾病方法、协调的管理、知识丰富的领导、经验丰富的临床中心和有效(重新)利用多个试验共同的组件的优势来实现。这次申请糖尿病黄斑水肿临床研究网络的研究主席核心是利用PI的独特资格来担任该网络的研究主席。在过去的十年中，PI通过参与糖尿病视网膜病变和DME的临床和研究评估而获得了国际认可。PI目前是3个正在进行的、多中心(100个站点)的随机临床试验的研究主席，评估糖尿病视网膜病变和DME的新疗法。这些研究是在PI的指导下进行的，使用了与本提案中提出的几乎相同的管理和临床框架。因此，PI在此类网络所需的协议开发和运营管理方面拥有独特的直接经验。此外，Joslin糖尿病中心将所有与糖尿病相关的医疗保健专业人员紧密整合在一起，并拥有基础和临床研究及技术能力，从而为试验网络提供特殊支持。该提案详细说明了在研究主席的指导下，如何促进网络的具体目标。

DESCRIPTION (provided by applicant): Diabetic macular edema (DME) remains a leading cause of visual loss in patients with diabetes mellitus. Increased understanding of this condition has prompted investigations of novel therapies for the treatment of DME, several of which are nearing clinical trial evaluation. Although therapeutic methodology may vary widely, the basic components requiring careful consideration in the design, implementation and analyses of high quality clinical trials are often similar. Furthermore, study sites with particular retinopathy trial expertise and experience are an excellent resource for a variety of such trials. The goal of this proposal is to establish a clinical trial network to evaluate new treatments for diabetic macular edema that may be more effective, better tolerated, or more readily administered than the present standard of laser photocoagulation. This initiative will utilize a framework specifically designed to provide accelerated clinical research, standardized treatment protocols, leveraged recruitment power of multiple centers and optimal resource utilization. These benefits will be realized through the advantages of a dedicated disease approach, coordinated administration, knowledgeable leadership, experienced clinical centers and efficient (re)utilization of components common to multiple trials. This application for the Study Chair core of the Diabetic Macular Edema Clinical Research Network exploits the PI's unique qualifications to serve as Study Chair for this network. Over the past decade, the PI has achieved international recognition through participation in clinical and research evaluation of diabetic retinopathy and DME. The PI is currently the Study Chair of 3 ongoing, multicenter (100 sites), randomized, clinical trials evaluating new therapies for diabetic retinopathy and DME. These studies are run under the PI's guidance using a nearly identical administrative and clinical framework as that presented in this proposal. Thus, the PI has unique direct experience in protocol development and operational management required within such a Network. Additionally, the Joslin Diabetes Center provides exceptional support for trial networks with its close integration of all diabetes-associated health care professionals and its basic and clinical research and technology prowess. This proposal details the manner in which the specific goals of the network will be fostered under the guidance of the Study Chair.