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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

NCT ID: NCT01342926

Last Updated: 2017-05-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-01

Study Completion Date

2016-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrophy, Geographic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GSK933776 3 mg/kg

3 mg/kg administration of GSK933776 via intravenous infusion

Group Type EXPERIMENTAL

GSK933776

Intervention Type DRUG

GSK933776

GSK933776 6 mg/kg

6 mg/kg administration of GSK933776 via intravenous infusion

Group Type EXPERIMENTAL

GSK933776

Intervention Type DRUG

GSK933776

Placebo

Placebo via intravenous infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

GSK933776 15 mg/kg

15 mg/kg administration of GSK933776 via intravenous infusion

Group Type EXPERIMENTAL

GSK933776

Intervention Type DRUG

GSK933776

Interventions

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GSK933776

GSK933776

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Arcadia, California, United States

Site Status

GSK Investigational Site

Irvine, California, United States

Site Status

GSK Investigational Site

La Jolla, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Palm Desert, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Torrance, California, United States

Site Status

GSK Investigational Site

Golden, Colorado, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Stuart, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Augusta, Georgia, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

New Albany, Indiana, United States

Site Status

GSK Investigational Site

Leawood, Kansas, United States

Site Status

GSK Investigational Site

Prairie Village, Kansas, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Paducah, Kentucky, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

GSK Investigational Site

Detroit, Michigan, United States

Site Status

GSK Investigational Site

Northfield, New Jersey, United States

Site Status

GSK Investigational Site

Toms River, New Jersey, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

West Mifflin, Pennsylvania, United States

Site Status

GSK Investigational Site

Ladson, South Carolina, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

Abilene, Texas, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Galveston, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status

GSK Investigational Site

Charlottesville, Virginia, United States

Site Status

GSK Investigational Site

Silverdale, Washington, United States

Site Status

GSK Investigational Site

Mississauga, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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114341

Identifier Type: -

Identifier Source: org_study_id

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