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.
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