Overview

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