UW Department of Ophthalmology: CLINICAL TRIALS

Clinical Trials

The Collaborative Initial Glaucoma Treatment Study (CIGTS) is a randomized, multicenter clinical trial, designed to determine whether patients with newly diagnosed open-angle glaucoma are better treated by initial treatment with medication or by immediate filtration surgery. It was previously funded by the National Eye Institute (NEI) of the National Institutes of Health (NIH), and recuitment ended in 1997 with 607 patients enrolled nationwide. Initial results showed no difference in outcome between the two arms, based on traditional ophthalmic measures as well as patients' health-related quality of life outcomes, but follow up continues. Philip P. Chen, M.D., Principal Investigator, Raghu Mudumbai, M.D., Co-Investigator, and Patricia Ernst, COA, study coordinator, follow the patients in this study.

The Memantine Phase 3 Study of Open Angle Glaucoma Patients is a randomized, multicenter,placebo-controlled, double-masked clinical trial, designed to determine whether memantine, an oral medication, is useful for prevention of progression of open angle glaucoma. It is funded by Allergan Corporation, and recruitment ended in 2001 with more than 500 patients in this study. Study procedures and follow up continue, and no results have yet been released. Philip P. Chen, M.D., Prinicipal Investigator, Raghu Mudumbai, M.D., Co-Investigator, and Patricia Ernst, COA, study coordiantor, follow the patients in this study.

NIH funding continues for intensive study of CD4 lymphocyte function and manipulation over time in a small group of HIV-infected patients, in relation to CMV-specific immunity. The principal investigators are Drs. Stan Riddell and Michael Boeckh at the Fred Hutchinson Cancer Research Center, with ophthalmologic collaboration contributed by Elaine L. Chuang, MD.

Ophthalmology and Endocrinology continue to collaborate on several studies of diabetes mellitus, including: Epidemiology of Diabetes Intervention and Complications Study (EDIC) to determine factors associated with complications of diabetes mellitus. James L. Kinyoun, M.D. is the principal investigator at the University of Washington for several national collaborative studies of a new diagnostic method and several new treatments for diabetic macular edema. These studies are sponsored by the National Eye Institute and will be conducted in approximately 100 clinical centers known as the DIABETIC RETINOPATHY CLINICAL RESEARCH. NET (DRCR.net). The new diagnostic method to detect and quantitate diabetic macular edema is OPTICAL COHERENCE TOMOGRAPHY (OCT). The OCT examinations will be compared with the more widely-used contact and hand-held lens examinations to determine agreement. The NEW treatments of diabetic macular edema which will be tested include: grid laser photocoagulation, intravitreal corticosteroids, peribulbar corticosteriods and vitrectomy. Eligible patients will be evaluated and enrolled at the University of Washington Eye Center.

				AIDS-Related Clinical Trials Glaucoma Clinical Trials UW Eye Center

	Clinical Trials The Collaborative Initial Glaucoma Treatment Study (CIGTS) is a randomized, multicenter clinical trial, designed to determine whether patients with newly diagnosed open-angle glaucoma are better treated by initial treatment with medication or by immediate filtration surgery. It was previously funded by the National Eye Institute (NEI) of the National Institutes of Health (NIH), and recuitment ended in 1997 with 607 patients enrolled nationwide. Initial results showed no difference in outcome between the two arms, based on traditional ophthalmic measures as well as patients' health-related quality of life outcomes, but follow up continues. Philip P. Chen, M.D., Principal Investigator, Raghu Mudumbai, M.D., Co-Investigator, and Patricia Ernst, COA, study coordinator, follow the patients in this study. The Memantine Phase 3 Study of Open Angle Glaucoma Patients is a randomized, multicenter,placebo-controlled, double-masked clinical trial, designed to determine whether memantine, an oral medication, is useful for prevention of progression of open angle glaucoma. It is funded by Allergan Corporation, and recruitment ended in 2001 with more than 500 patients in this study. Study procedures and follow up continue, and no results have yet been released. Philip P. Chen, M.D., Prinicipal Investigator, Raghu Mudumbai, M.D., Co-Investigator, and Patricia Ernst, COA, study coordiantor, follow the patients in this study. NIH funding continues for intensive study of CD4 lymphocyte function and manipulation over time in a small group of HIV-infected patients, in relation to CMV-specific immunity. The principal investigators are Drs. Stan Riddell and Michael Boeckh at the Fred Hutchinson Cancer Research Center, with ophthalmologic collaboration contributed by Elaine L. Chuang, MD. Ophthalmology and Endocrinology continue to collaborate on several studies of diabetes mellitus, including: Epidemiology of Diabetes Intervention and Complications Study (EDIC) to determine factors associated with complications of diabetes mellitus. James L. Kinyoun, M.D. is the principal investigator at the University of Washington for several national collaborative studies of a new diagnostic method and several new treatments for diabetic macular edema. These studies are sponsored by the National Eye Institute and will be conducted in approximately 100 clinical centers known as the DIABETIC RETINOPATHY CLINICAL RESEARCH. NET (DRCR.net). The new diagnostic method to detect and quantitate diabetic macular edema is OPTICAL COHERENCE TOMOGRAPHY (OCT). The OCT examinations will be compared with the more widely-used contact and hand-held lens examinations to determine agreement. The NEW treatments of diabetic macular edema which will be tested include: grid laser photocoagulation, intravitreal corticosteroids, peribulbar corticosteriods and vitrectomy. Eligible patients will be evaluated and enrolled at the University of Washington Eye Center.