Atrophy, Geographic Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 190 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | GSK Investigational Site | Mississauga | Ontario |
United States | GSK Investigational Site | Abilene | Texas |
United States | GSK Investigational Site | Arcadia | California |
United States | GSK Investigational Site | Augusta | Georgia |
United States | GSK Investigational Site | Austin | Texas |
United States | GSK Investigational Site | Baltimore | Maryland |
United States | GSK Investigational Site | Baltimore | Maryland |
United States | GSK Investigational Site | Boston | Massachusetts |
United States | GSK Investigational Site | Charlottesville | Virginia |
United States | GSK Investigational Site | Detroit | Michigan |
United States | GSK Investigational Site | Galveston | Texas |
United States | GSK Investigational Site | Golden | Colorado |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Indianapolis | Indiana |
United States | GSK Investigational Site | Irvine | California |
United States | GSK Investigational Site | La Jolla | California |
United States | GSK Investigational Site | Ladson | South Carolina |
United States | GSK Investigational Site | Leawood | Kansas |
United States | GSK Investigational Site | Los Angeles | California |
United States | GSK Investigational Site | Louisville | Kentucky |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Nashville | Tennessee |
United States | GSK Investigational Site | New Albany | Indiana |
United States | GSK Investigational Site | New York | New York |
United States | GSK Investigational Site | North Dartmouth | Massachusetts |
United States | GSK Investigational Site | Northfield | New Jersey |
United States | GSK Investigational Site | Paducah | Kentucky |
United States | GSK Investigational Site | Palm Desert | California |
United States | GSK Investigational Site | Philadelphia | Pennsylvania |
United States | GSK Investigational Site | Philadelphia | Pennsylvania |
United States | GSK Investigational Site | Phoenix | Arizona |
United States | GSK Investigational Site | Phoenix | Arizona |
United States | GSK Investigational Site | Prairie Village | Kansas |
United States | GSK Investigational Site | Salt Lake City | Utah |
United States | GSK Investigational Site | San Francisco | California |
United States | GSK Investigational Site | Silverdale | Washington |
United States | GSK Investigational Site | Stuart | Florida |
United States | GSK Investigational Site | Tampa | Florida |
United States | GSK Investigational Site | Toms River | New Jersey |
United States | GSK Investigational Site | Torrance | California |
United States | GSK Investigational Site | West Mifflin | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of change in area of geographic atrophy from baseline | Baseline and 12 and 18 months | No | |
Secondary | Change from baseline in best-corrected visual acuity | Baseline and 18 months | No | |
Secondary | Estimation of PK parameter in geographic atrophy | visits 3-6,9,12,13,18 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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Phase 3 | |
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