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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01342926
First received: April 26, 2011
Last updated: September 25, 2014
Last verified: August 2014
  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:


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 ]
  • Estimation of PK parameter in geographic atrophy [ Time Frame: visits 3-6,9,12,13,18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 184
Study Start Date: June 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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
Experimental: GSK933776 15 mg/kg
15 mg/kg administration of GSK933776 via intravenous infusion
Drug: GSK933776
GSK933776

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
  • More than moderate MRI white matter changes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342926

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85014
GSK Investigational Site
Phoenix, Arizona, United States, 85020
United States, California
GSK Investigational Site
Arcadia, California, United States, 91007
GSK Investigational Site
Irvine, California, United States, 92697-4375
GSK Investigational Site
La Jolla, California, United States, 92037
GSK Investigational Site
Los Angeles, California, United States, 90033-4500
GSK Investigational Site
Palm Desert, California, United States, 92260
GSK Investigational Site
San Francisco, California, United States, 94143
GSK Investigational Site
Torrance, California, United States, 90503
United States, Colorado
GSK Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Stuart, Florida, United States, 34994
GSK Investigational Site
Tampa, Florida, United States, 33612
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30909
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46290
GSK Investigational Site
New Albany, Indiana, United States, 47150
United States, Kansas
GSK Investigational Site
Leawood, Kansas, United States, 66211
GSK Investigational Site
Prairie Village, Kansas, United States, 66208
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40215
GSK Investigational Site
Paducah, Kentucky, United States, 42001
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21204
GSK Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02111
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
United States, New Jersey
GSK Investigational Site
Northfield, New Jersey, United States, 08225
GSK Investigational Site
Toms River, New Jersey, United States, 08755
United States, New York
GSK Investigational Site
New York, New York, United States, 10003
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site
West Mifflin, Pennsylvania, United States, 15122
United States, South Carolina
GSK Investigational Site
Ladson, South Carolina, United States, 29406
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Abilene, Texas, United States, 79606
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Galveston, Texas, United States, 77555-1106
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22903
United States, Washington
GSK Investigational Site
Silverdale, Washington, United States, 98383
Canada, Ontario
GSK Investigational Site
Mississauga, Ontario, Canada, L4W 1W9
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: September 25, 2014
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 October 19, 2014