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
  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

  Show 41 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: August 14, 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 September 16, 2014