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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 currently recruiting participants.
Verified March 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01342926
First received: April 26, 2011
Last updated: May 9, 2013
Last verified: March 2013
History of Changes
  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:

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

Contacts
Contact: US GSK Clinical Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 34 Study Locations
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 19, 2013