MODIFICATION
A -- Coordinating Center to Support a Multi-center, Randomized Trial of Lutein/Zeaxanthin and Omega-3 LCPUFAs in Age-Related Macular Degeneration
- Notice Date
- 11/3/2004
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Division of Research Acquisition, 6100 Executive Boulevard, Room 6E01, MSC 7540, Bethesda, MD, 20892-7540
- ZIP Code
- 20892-7540
- Solicitation Number
- 260-05-01
- Response Due
- 1/31/2005
- Archive Date
- 2/15/2005
- Description
- The National Eye Institute, National Institutes of Health, has a requirement for a Coordinating Center to Support a Multi-center, Randomized Trial of Lutein/Zeaxanthin and Omega-3 LCPUFAs in Age-Related Macular Degeneration. The NEI intends to implement Phase III clinical trial on two nutritionally-based preventive interventions for age-related macular degeneration (AMD) and cataract in people at risk for developing sight threatening forms of AMD. The primary objective of this Phase III trial is to determine whether oral supplementation with macular xanthophylls (lutein and zeaxanthin) and/or omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) will decrease the progression to advanced age-related macular degeneration compared to placebo as determined by fundus photographs. The effect of lutein and/or omega-3 LCPUFAs on lens opacity will be measured based on the incidence of cataract surgery. The contractor will perform three integrated core services: (1) conduct of background research to support aspects of study design, data management and analysis, and manuscript production; (2) development and maintenance of a research infrastructure for recruitment, training, communication, and monitoring of participating Clinical Sites (20 - 100); and (3) development and implementation of research protocols necessary for conduct of the trial. In addition, the contractor will operate as a hub to manage the integration of resource sharing, system organization, and project monitoring of a reading center, a drug distribution center, a nutrition coordinating center, and a central biochemistry laboratory. An eight-year, cost reimbursement type contract is anticipated, with award to be made in September 2005. RFP 260-05-01 will be available on or about December 1, 2004, and will be posted on this website. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal which shall be considered by the Government. See numbered note 26.
- Record
- SN00703092-W 20041105/041103211727 (fbodaily.com)
- Source
-
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