Microplasmin Intravitreal Administration in Participants with Uveitic Macular Edema Clinical Protocol support contract designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies. In addition, it will provide for outcomes research involving eye diseases and visual disorders and some preclinical studies. The focus shall be on the design of studies and the collection, analysis, and interpretation of data emanating from these studies, as well as support, and monitoring patient safety and follow-up. Contractor shall also provide analytical and data management support, as described in the work statement, for specified clinical research data bases, cost-effectiveness and economic analyses, quality of life assessment and outcomes research. This will include, but not be limited to, the following areas: analysis of Medicare and other health care databases;evaluation of existing NEI databases such as, centralized NEI Intramural Research database, the Eye Disease Case Control Study, Early Treatment Diabetic Retinopathy Study, Framingham Eye Study, and intramural AIDS and uveitis databases. Objective of Clinical Protocol: - Uveitis is a serious inflammatory condition in which the body's immune system attacks parts of the eye, often causing vision loss. Some people with uveitis also have macular edema (swelling of the retina at the back of the eye). Uveitis and macular edema are treated with medications and sometimes surgery, but in many people treatment does not prevent vision loss. - Research has shown that injection of the lab-made protein microplasmin into the eye of people with eye disease other than uveitis can help treat macular edema and can slow visual loss. Microplasmin has not been approved to treat uveitis;however, researchers are interested in determining if it can be a safe and effective treatment for macular edema related to uveitis. Objectives: - To investigate the safety, tolerability and potential efficacy of an intravitreal injection of microplasmin as a possible treatment for macular edema secondary to uveitis.
