Trial record 1 of 2 for:    gsk geographic atrophy
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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: August 14, 2014
Last verified: July 2014

April 26, 2011
August 14, 2014
June 2011
April 2016   (final data collection date for primary outcome measure)
Rate of change in area of geographic atrophy from baseline [ Time Frame: Baseline and 12 and 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01342926 on ClinicalTrials.gov Archive Site
  • 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 ]
Change from baseline in best-corrected visual acuity [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrophy, Geographic
  • Drug: GSK933776
    GSK933776
  • Drug: Placebo
    Placebo
  • Experimental: GSK933776 3 mg/kg
    3 mg/kg administration of GSK933776 via intravenous infusion
    Intervention: Drug: GSK933776
  • Experimental: GSK933776 6 mg/kg
    6 mg/kg administration of GSK933776 via intravenous infusion
    Intervention: Drug: GSK933776
  • Placebo Comparator: Placebo
    Placebo via intravenous infusion
    Intervention: Drug: Placebo
  • Experimental: GSK933776 15 mg/kg
    15 mg/kg administration of GSK933776 via intravenous infusion
    Intervention: Drug: GSK933776
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
184
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01342926
114341
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP