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

Completed · Phase 2 · Has a placebo group

Conditions studied: Atrophy, Geographic

In brief

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.

Key facts

Study ID

NCT01342926

Run by

GlaxoSmithKline

People needed

191

Starts

2011-06-01

Expected to finish

2016-04-01

Last updated by the study team

2017-05-05

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Arcadia, California, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Palm Desert, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Golden, Colorado, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Stuart, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Augusta, Georgia, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — New Albany, Indiana, United States
• GSK Investigational Site — Leawood, Kansas, United States
• GSK Investigational Site — Prairie Village, Kansas, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Paducah, Kentucky, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — North Dartmouth, Massachusetts, United States
• GSK Investigational Site — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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