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Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration

NCT ID: NCT01134055

Last Updated: 2018-01-08

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-01

Study Completion Date

2012-10-01

Brief Summary

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The purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.

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Detailed Description

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MD7110852 is a Phase 2b dose-ranging study designed to demonstrate the 1 year efficacy and safety of pazopanib eye drops for the treatment of neovascular age related macular degeneration (AMD) in subjects whose disease is currently managed with anti-VEGF (vascular endothelial growth factor) injection therapy. Eye drop regimens are double-masked with placebo eye drops and will have access to open-label ranibizumab intravitreal (IVT) injection if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.

Conditions

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Macular Degeneration

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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investigational arm 1

5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection

Group Type EXPERIMENTAL

pazopanib eye drops

Intervention Type DRUG

A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.

investigational arm 2

5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection

Group Type EXPERIMENTAL

pazopanib eye drops

Intervention Type DRUG

A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.

investigational arm 3

10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection

Group Type EXPERIMENTAL

pazopanib eye drops

Intervention Type DRUG

A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.

investigational arm 4

10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection

Group Type EXPERIMENTAL

pazopanib eye drops

Intervention Type DRUG

A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.

investigational arm 5

10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection

Group Type EXPERIMENTAL

pazopanib eye drops

Intervention Type DRUG

A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.

placebo control arm

Placebo eye drops QID with allowance for as-needed ranibizumab injection

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo eye drops

active open-label control arm

Ranibizumab intravitreal injection every 4 weeks

Group Type ACTIVE_COMPARATOR

ranibizumab intravitreal injection

Intervention Type BIOLOGICAL

Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A

Interventions

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pazopanib eye drops

A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.

Intervention Type DRUG

placebo

placebo eye drops

Intervention Type DRUG

ranibizumab intravitreal injection

Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Men and women aged ≥50 years.
* Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area.
* Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and in need of re-treatment.
* Best-corrected visual acuity of at least 24 letters (equates to approximately 20/320 Snellen equivalents or better).

Exclusion Criteria

* Prior ocular investigational drug/device for choroidal neovascularization, photodynamic therapy, radiation, subfoveal or juxtafoveal focal laser photocoagulation.
* Prior failure to anti-VEGF intravitreal injection therapy.
* Recent ocular investigational drug/device for non-CNV condition.
* Prior ocular surgeries (vitrectomy, scleral buckle, or glaucoma filtering/shunt surgery). Cataract surgery permitted if ≥3 months and has posterior chamber intraocular lens.
* Center-fovea involvement of any of the following: fibrosis, atrophy, serous retinal pigment epithelial detachment, or retinal pigment epithelial tear.
* CNV in either eye due to other causes.
* Clinical evidence of diabetic retinopathy or diabetic macular edema.
* Recent myocardial infarction or cerebrovascular accident.
* Uncontrolled hypertension in spite of antihypertensive medications.
Minimum Eligible Age

50 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

Peoria, Arizona, United States

Site Status

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Irvine, California, United States

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Loma Linda, California, United States

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Poway, California, United States

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Santa Ana, California, United States

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Golden, Colorado, United States

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Fort Myers, Florida, United States

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Winter Haven, Florida, United States

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Chicago, Illinois, United States

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Leawood, Kansas, United States

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Paducah, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Royal Oak, Michigan, United States

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Traverse City, Michigan, United States

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New York, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Beachwood, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Ashland, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Silverdale, Washington, United States

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Madison, Wisconsin, United States

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Sydney, New South Wales, Australia

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Sydney, New South Wales, Australia

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Melbourne, Victoria, Australia

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Nedlands, Western Australia, Australia

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Brussels, , Belgium

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Liège, , Belgium

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Aarhus, , Denmark

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GSK Investigational Site

Glostrup Municipality, , Denmark

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GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Tübingen, Baden-Wurttemberg, Germany

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Munich, Bavaria, Germany

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Bonn, North Rhine-Westphalia, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Kiel, Schleswig-Holstein, Germany

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Udine, Friuli Venezia Giulia, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Turin, Piedmont, Italy

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Padua, Veneto, Italy

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GSK Investigational Site

Aichi, , Japan

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GSK Investigational Site

Aichi, , Japan

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GSK Investigational Site

Aichi, , Japan

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GSK Investigational Site

Chiba, , Japan

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GSK Investigational Site

Fukuoka, , Japan

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GSK Investigational Site

Fukushima, , Japan

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GSK Investigational Site

Hokkaido, , Japan

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GSK Investigational Site

Hokkaido, , Japan

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GSK Investigational Site

Kagawa, , Japan

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Tokyo, , Japan

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GSK Investigational Site

Linköping, , Sweden

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GSK Investigational Site

Örebro, , Sweden

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GSK Investigational Site

Stockholm, , Sweden

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GSK Investigational Site

Uppsala, , Sweden

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Countries

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United States Australia Belgium Canada Denmark Germany Italy Japan Sweden

Other Identifiers

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110852

Identifier Type: -

Identifier Source: org_study_id

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