Trial record 3 of 3 for:
GSK933776
Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
This study is currently recruiting participants.
Verified March 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01342926
First received: April 26, 2011
Last updated: May 9, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrophy, Geographic |
Drug: GSK933776 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Rate of change in area of geographic atrophy from baseline [ Time Frame: Baseline and 12 and 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in best-corrected visual acuity [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 174 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GSK933776 3 mg/kg
3 mg/kg administration of GSK933776 via intravenous infusion
|
Drug: GSK933776
GSK933776
|
|
Experimental: GSK933776 6 mg/kg
6 mg/kg administration of GSK933776 via intravenous infusion
|
Drug: GSK933776
GSK933776
|
|
Placebo Comparator: Placebo
Placebo via intravenous infusion
|
Drug: Placebo
Placebo
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342926
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Contacts
| Contact: US GSK Clinical Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Hide Study LocationsLocations
| United States, Arizona | |
| GSK Investigational Site | Recruiting |
| Phoenix, Arizona, United States, 85014 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Phoenix, Arizona, United States, 85020 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, California | |
| GSK Investigational Site | Recruiting |
| Arcadia, California, United States, 91007 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Irvine, California, United States, 92697 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Los Angeles, California, United States, 90033-4500 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Rancho Mirage, California, United States, 92208 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Torrance, California, United States, 90503 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Colorado | |
| GSK Investigational Site | Recruiting |
| Golden, Colorado, United States, 80401 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Florida | |
| GSK Investigational Site | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Georgia | |
| GSK Investigational Site | Recruiting |
| Augusta, Georgia, United States, 30909 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Indiana | |
| GSK Investigational Site | Recruiting |
| Indianapolis, Indiana, United States, 46290 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| New Albany, Indiana, United States, 47150 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Kansas | |
| GSK Investigational Site | Recruiting |
| Leawood, Kansas, United States, 66211 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Kentucky | |
| GSK Investigational Site | Recruiting |
| Louisville, Kentucky, United States, 40215 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Paducah, Kentucky, United States, 42001 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Maryland | |
| GSK Investigational Site | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Massachusetts | |
| GSK Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Michigan | |
| GSK Investigational Site | Not yet recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, New Jersey | |
| GSK Investigational Site | Recruiting |
| Northfield, New Jersey, United States, 08225 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, New York | |
| GSK Investigational Site | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Pennsylvania | |
| GSK Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, South Carolina | |
| GSK Investigational Site | Recruiting |
| Ladson, South Carolina, United States, 29406 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Texas | |
| GSK Investigational Site | Recruiting |
| Abilene, Texas, United States, 79606 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Austin, Texas, United States, 78705 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Galveston, Texas, United States, 77555-1106 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Utah | |
| GSK Investigational Site | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United States, Virginia | |
| GSK Investigational Site | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Canada, Ontario | |
| GSK Investigational Site | Recruiting |
| Mississauga, Ontario, Canada, L4W 1W9 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01342926 History of Changes |
| Other Study ID Numbers: | 114341 |
| Study First Received: | April 26, 2011 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada - Biologics and Genetic Therapies Directorate |
Keywords provided by GlaxoSmithKline:
|
age-related macular degeneration geographic atrophy dry AMD |
Additional relevant MeSH terms:
|
Macular Degeneration Atrophy Geographic Atrophy Retinal Degeneration |
Retinal Diseases Eye Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013