Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia with Neovascularization (MACTEL 1) 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: This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss in people with macular telangiectasia, a condition in which new blood vessels grow in the retina at the back of the eye and can leak. Such changes in blood vessels are seen in other diseases associated with changes in a body chemical called vascular endothelial growth factor (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease, age-related macular degeneration, with similar changes in eye blood vessels. People 18 years of age and older with macular telangiectasia in both eyes and new blood vessel growth in at least one eye may be eligible for this study. They must have vision better than 20/400 in the study eye.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research and Development Contracts (N01)
Project #
N01EY70001-15-0-20
Application #
8075873
Study Section
Project Start
2006-11-01
Project End
2011-10-31
Budget Start
Budget End
Support Year
Fiscal Year
2010
Total Cost
$42,595
Indirect Cost
Name
Emmes Corporation
Department
Type
DUNS #
096360284
City
Rockville
State
MD
Country
United States
Zip Code
20850