A Phase 2, Multi-centre, Randomised, Double-masked, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of GSK933776 in Adult Patients With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Description
Detailed Description
This is a Phase 2a proof of concept study designed to evaluate the safety and efficacy of
GSK933776 for the treatment of geographic atrophy secondary to age-related macular
degeneration. This is a placebo-controlled parallel-group study that is double masked.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion Criteria
- Inclusion Criteria:
- Adult patients ≥55 years of age inclusive
- Evidence of AMD confirmed by the presence of at least 1 druse ≥125 μm diameter
- Well-demarcated GA due to AMD of total area 1.9-17 mm2 measured in the study eye
- Best-corrected visual acuity score of ≥ 35 letters (approximately 20/200 Snellen VA equivalent or better) in the study eye Exclusion Criteria:
- Additional eye disease in the study eye that could compromise assessment of best-corrected visual acuity or imaging of the posterior pole
- History of CNV secondary to AMD in the study eye
- Any previous treatment for AMD in the study eye, approved or investigational, with the exception of dietary supplements
- Risk of cerebrovascular disease, cerebral hemorrhage or stroke
- History of systemic autoimmune disease
- Use of platelet anti-aggregants or anti-coagulants (aspirin up to 325 mg/day is allowable, or in subjects allergic or intolerable to aspirin, clopidogrel up to 75 mg/day is allowable)
- Use of chronic corticosteroids
- Uncontrolled hypertension in spite of antihypertensive medications
- Renal or hepatic insufficiency or clinically significant anemia
- More than moderate MRI white matter changes
Sites
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California
- GSK Investigational Site, Arcadia, California, 91007
- GSK Investigational Site, Torrance, California, 90503
- GSK Investigational Site, La Jolla, California, 92037
- GSK Investigational Site, Palm Desert, California, 92260
- GSK Investigational Site, San Francisco, California, 94143
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Arizona
- GSK Investigational Site, Phoenix, Arizona, 85020
- GSK Investigational Site, Phoenix, Arizona, 85014
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Utah
- GSK Investigational Site, Salt Lake City, Utah, 84132
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Colorado
- GSK Investigational Site, Golden, Colorado, 80401
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Washington
- GSK Investigational Site, Silverdale, Washington, 98383
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Texas
- GSK Investigational Site, Abilene, Texas, 79606
- GSK Investigational Site, Austin, Texas, 78705
- GSK Investigational Site, Houston, Texas, 77030
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Kansas
- GSK Investigational Site, Leawood, Kansas, 66211
- GSK Investigational Site, Prairie Village, Kansas, 66208
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Kentucky
- GSK Investigational Site, Paducah, Kentucky, 42001
- GSK Investigational Site, Louisville, Kentucky, 40215
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Tennessee
- GSK Investigational Site, Nashville, Tennessee, 37203
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Indiana
- GSK Investigational Site, Indianapolis, Indiana, 46290
- GSK Investigational Site, New Albany, Indiana, 47150
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