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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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