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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Atrophy, Geographic

Treatments: Drug: GSK933776; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342926

114341

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 191 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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191 participants in 4 patient groups, including a placebo group

GSK933776 3 mg/kg

Experimental group

Description:

3 mg/kg administration of GSK933776 via intravenous infusion

Treatment:

Drug: GSK933776

GSK933776 6 mg/kg

Experimental group

Description:

6 mg/kg administration of GSK933776 via intravenous infusion

Treatment:

Drug: GSK933776

Placebo

Placebo Comparator group

Description:

Placebo via intravenous infusion

Treatment:

Drug: Placebo

GSK933776 15 mg/kg

Experimental group

Description:

15 mg/kg administration of GSK933776 via intravenous infusion

Treatment:

Drug: GSK933776