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

Atrophy, Geographic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342926
• Other study ID #: 114341
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2011
• Last updated: October 6, 2016
• Start date: June 2011
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada - Biologics and Genetic Therapies Directorate
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Atrophy, Geographic
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• GSK933776
GSK933776
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Mississauga	Ontario
United States	GSK Investigational Site	Abilene	Texas
United States	GSK Investigational Site	Arcadia	California
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Golden	Colorado
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Ladson	South Carolina
United States	GSK Investigational Site	Leawood	Kansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Albany	Indiana
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	North Dartmouth	Massachusetts
United States	GSK Investigational Site	Northfield	New Jersey
United States	GSK Investigational Site	Paducah	Kentucky
United States	GSK Investigational Site	Palm Desert	California
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Prairie Village	Kansas
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Silverdale	Washington
United States	GSK Investigational Site	Stuart	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toms River	New Jersey
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	West Mifflin	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in area of geographic atrophy from baseline		Baseline and 12 and 18 months	No
Secondary	Change from baseline in best-corrected visual acuity		Baseline and 18 months	No
Secondary	Estimation of PK parameter in geographic atrophy		visits 3-6,9,12,13,18	No