This specialized research center with more than 10,000 patients on file with retinitis pigmentosa proposes a clinical trial to determine whether a nutritional supplement will slow the course of the common forms of retinitis pigmentosa. Two hundred and eleven patients who meet a preset list of eligibility criteria will be randomly assigned to either a treatment or a control group and followed annually over a period of 5 years. All patients will receive 15,000 IU/day of vitamin A palmitate. Static perimetric thresholds measured with a Humphrey Field Analyzer will be used as the primary outcome measure. Electroretinograms, visual acuities, and assessment of quality of life will be monitored as secondary outcome measures. The study will be conducted with a double-masked protocol. Collaborative arrangements have been made for biochemical analyses with Tufts University School of Medicine and Brandeis University.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY013945-03
Application #
6789376
Study Section
Special Emphasis Panel (ZEY1-VSN (02))
Program Officer
Redford, Maryann
Project Start
2002-07-01
Project End
2007-06-30
Budget Start
2004-07-01
Budget End
2005-06-30
Support Year
3
Fiscal Year
2004
Total Cost
$871,077
Indirect Cost
Name
Harvard University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
047006379
City
Boston
State
MA
Country
United States
Zip Code
02115
Berson, Eliot L; Rosner, Bernard; Sandberg, Michael A et al. (2012) ?-3 intake and visual acuity in patients with retinitis pigmentosa receiving vitamin A. Arch Ophthalmol 130:707-11
Berson, Eliot L; Rosner, Bernard; Sandberg, Michael A et al. (2010) Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A. Arch Ophthalmol 128:403-11