This revised application requests support for the Coordinating Center for the multicenter Advanced Glaucoma Intervention Study (AGIS). The EMMES Corporation staff participated with the 10 clinical centers in preparing the AGIS Manual of Operations and research plan which was submitted with the lead application from Georgetown University. The qualifications of the institute to participate in AGIS are described in terms of personnel, extensive coordinating center experience, facilities, and other resources of The EMMES Corporation. The Coordinating Center will assist AGIS in its primary goal to systematically assess the long-range outcomes of sequences of interventions in 840 eyes that have failed initial medical treatment for glaucoma. Eligible eyes will be randomly assigned to one of two intervention sequences. Eyes that fail the assigned sequence of three interventions will be managed by additional surgery. The interventions will be supplemented with medical treatment as needed. All patients woll be followed for at least five years to determine degree of visual function loss, rates of failure of interventions and intervention sequences, rates of complications, and need for supplemental therapy. The prognostic value of ocular, systemic, personal, and social factors, including compliance, will be studied. Participating institutions will adhere to common, specified definitions, eligibility criteria, methods of measurement, as well as diagnostic, treatment, quality control, and administrative procedures. A Coordinating Center will collect, process, and analyze study data and coordinate study activities; a Policy and Treatment Effects Monitoring Board will supervise the conduct of the study.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY007057-05
Application #
3559536
Study Section
Vision Research and Training Committee (VSN)
Project Start
1987-09-01
Project End
1992-08-31
Budget Start
1991-09-01
Budget End
1992-08-31
Support Year
5
Fiscal Year
1991
Total Cost
Indirect Cost
Name
Emmes Corporation
Department
Type
DUNS #
City
Rockville
State
MD
Country
United States
Zip Code
20850