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

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