Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - Any
Updated:4/21/2016
Start Date:June 2011
End Date:April 2016

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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)

The purpose of this study is to determine the safety and efficacy of GSK933776 in the
treatment of geographic atrophy secondary to age-related macular degeneration.

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.

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
We found this trial at
41
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New York, New York 10032
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Abilene, Texas 79606
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Arcadia, California 91007
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Augusta, Georgia 30909
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Augusta, GA
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Austin, Texas 78705
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Baltimore, Maryland 21201
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Baltimore, Maryland 21201
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Boston, Massachusetts 02115
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Charlottesville, Virginia 22903
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Detroit, Michigan 48202
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Galveston, Texas 77555
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Golden, Colorado 80401
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Houston, Texas 77030
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Irvine, California 92697
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La Jolla, California 92093
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Ladson, South Carolina 29406
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Leawood, Kansas 66211
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Los Angeles, California 90025
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Louisville, Kentucky 40202
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Miami, Florida 33136
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Mississauga, Ontario
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Nashville, Tennessee 37203
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New Albany, Indiana 47150
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North Dartmouth, Massachusetts 02747
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Northfield, New Jersey 08225
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Paducah, Kentucky 42001
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Palm Desert, California 92260
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Philadelphia, Pennsylvania 19104
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85012
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Phoenix, Arizona 85012
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Prairie Village, Kansas 66208
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Salt Lake City, Utah 84132
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San Francisco, California 94115
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Silverdale, Washington 98383
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Stuart, Florida 34994
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Tampa, Florida 33612
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Toms River, New Jersey 08755
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Torrance, California 90502
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West Mifflin, Pennsylvania 15122
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