Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Status: | Active, not recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 55 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2011 |
End Date: | April 2016 |
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.
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.
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
We found this trial at
41
sites
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