The specialized research center with more than 4000 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 twenty 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. Static perimetric thresholds measured with the Humphrey Field Analyzer will be used as the primary outcome measure. Electroretinogram amplitudes and visual acuities will be monitored as secondary outcome measures. The trial will be conducted with a double-masked protocol. Collaborative arrangements have been made for biochemical analysis of blood specimens to monitor safety and compliance. Results will be followed by an outside Data Safety and Monitoring Committee.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY011030-06
Application #
6340574
Study Section
Special Emphasis Panel (SRC (04))
Program Officer
Kurinij, Natalie
Project Start
1995-09-01
Project End
2002-08-31
Budget Start
2000-09-01
Budget End
2001-08-31
Support Year
6
Fiscal Year
2000
Total Cost
$797,780
Indirect Cost
Name
Harvard University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
082359691
City
Boston
State
MA
Country
United States
Zip Code
02115
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