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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to perform exploratory analyses to evaluate rates of functional and structural change in glaucoma, to identify predictors of rapid progression in patients with glaucoma and to identify possible genetic factors and biomarkers associated with the disease.
PRIMARY OBJECTIVES
To identify and combine a set of predictors (i.e. by statistical modeling, machine learning classifiers or neural networks) to predict progression in glaucoma patients To determine how to most sensitively and specifically determine progression for a trial of a potential neuroprotective agent.
SECONDARY OBJECTIVES
To evaluate genetic and other potential biomarkers associated with progression in glaucoma.
To evaluate tests currently used on glaucoma patients to better predict which ones are most sensitive to detect disease progression and measure rates of change.
To assess progression by structural and functional tests:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Open Angle Glaucoma | • Group A (diagnosis of primary open-angle glaucoma or pseudo-exfoliative glaucoma) - subjects with documented disease progression in the past and high IOP (IOP above target), disc hemorrhage, family history of glaucoma-related vision loss or thin central cornea (<510um),
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| Healthy Individuals | • Group B (healthy controls)- healthy subjects without any ophthalmic disease and an IOP < 22mmHg o Normal appearing optic disc and no evidence of optic disc damage |
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INCLUSION CRITERIA
Subjects will be eligible if the following criteria are met:
Group A (diagnosis of primary open-angle glaucoma or pseudo-exfoliative glaucoma) - subjects with documented disease progression in the past 3 years and high IOP (IOP above target), disc hemorrhage (within 3 years), family history of glaucoma-related vision loss or thin central cornea (<510um),
Group B (healthy controls)- healthy subjects without any ophthalmic disease and an IOP < 22mmHg
o Normal appearing optic disc and no evidence of optic disc damage
Ability to provide written informed consent for participation in this study
EXCLUSION CRITERIA
Subjects who meet any of the following criteria will be excluded from this study:
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Primary Open Angle Glaucoma Health Individuals
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| Name | Affiliation | Role |
|---|---|---|
| Robert Weinreb, MD | UCSD Shiley Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Glaucoma Center, UCSD | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19376584 | Background | Medeiros FA, Alencar LM, Zangwill LM, Sample PA, Weinreb RN. The Relationship between intraocular pressure and progressive retinal nerve fiber layer loss in glaucoma. Ophthalmology. 2009 Jun;116(6):1125-33.e1-3. doi: 10.1016/j.ophtha.2008.12.062. Epub 2009 Apr 19. | |
| 20541265 | Background | Medeiros FA, Alencar LM, Sample PA, Zangwill LM, Susanna R Jr, Weinreb RN. The relationship between intraocular pressure reduction and rates of progressive visual field loss in eyes with optic disc hemorrhage. Ophthalmology. 2010 Nov;117(11):2061-6. doi: 10.1016/j.ophtha.2010.02.015. Epub 2010 Jun 11. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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All patients will also have blood samples drawn for genetic analysis and potential biomarker testing at Day 0 or at another visit during the study.
| 19815731 | Background | Medeiros FA, Zangwill LM, Alencar LM, Bowd C, Sample PA, Susanna R Jr, Weinreb RN. Detection of glaucoma progression with stratus OCT retinal nerve fiber layer, optic nerve head, and macular thickness measurements. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5741-8. doi: 10.1167/iovs.09-3715. Epub 2009 Oct 8. |
| 20036010 | Background | Alencar LM, Zangwill LM, Weinreb RN, Bowd C, Vizzeri G, Sample PA, Susanna R Jr, Medeiros FA. Agreement for detecting glaucoma progression with the GDx guided progression analysis, automated perimetry, and optic disc photography. Ophthalmology. 2010 Mar;117(3):462-70. doi: 10.1016/j.ophtha.2009.08.012. Epub 2009 Dec 24. |