The applicant, a participant in the current Herpetic Eye Disease Study (HEDS), proposes to be a Regional Center for Phase II of the Herpetic Eye Disease Study. Phase II will consist of two randomized, double-masked clinical trials and a nonexperimental study of triggers of recurrence of ocular herpetic disease. The first trial, HEDS-EKT, will compare acyclovir to placebo for the prevention or delay of subsequent keratitis or iritis in patients with active herpetic epithelial keratitis. The second, HEDS-APT, will compare acyclovir to placebo for prolonging time to recurrence of herpetic eye disease in patients with an episode of any herpetic eye disease in the past year and who have been free of disease and off all treatment for the past month. The triggers study will obtain data by questionnaire on stress, stress, trauma, and other potential triggers of recurrence or herpetic disease for correlation with recurrence data from the two clinical trials. As a Regional Center, the applicant will be responsible for entering patients in the two clinical trials, and treating and following them according to protocol; entering consenting randomized patients into the triggers study; coordinating and overseeing the participating of 9 additional participating local sites in the APT and EKT trials; and participating in the governance of HEDS via participation on the Executive Committee.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10EY009692-01
Application #
3559970
Study Section
Vision Research and Training Committee (VSN)
Project Start
1992-08-01
Project End
1997-07-31
Budget Start
1992-08-01
Budget End
1993-07-31
Support Year
1
Fiscal Year
1992
Total Cost
Indirect Cost
Name
Wills Eye Hospital (Philadelphia)
Department
Type
DUNS #
073744203
City
Philadelphia
State
PA
Country
United States
Zip Code
19107