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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:1/10/2018
Start Date:June 1, 2010
End Date:October 1, 2012

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MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops Versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration

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.

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.

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.
We found this trial at
35
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Portland, Oregon 97227
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Asheville, North Carolina 28803
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Ashland, Oregon 97520
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Austin, Texas 78705
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Baltimore, Maryland 21201
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Beachwood, Ohio 44122
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Boston, Massachusetts 02115
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Boston, MA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Charlotte, North Carolina 28203
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Charlotte, NC
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Chicago, Illinois 60611
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Chicago, IL
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Cleveland, Ohio 44195
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Columbus, Ohio 43219
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Dallas, Texas 75230
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Fort Myers, Florida 33916
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Fort Worth, Texas 76104
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Golden, Colorado 80401
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Irvine, California 92697
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Leawood, Kansas 66211
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Loma Linda, California 92357
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Madison, Wisconsin 53792
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New York, New York 10032
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Paducah, Kentucky 42001
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Peoria, Arizona 85381
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85012
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Poway, California 92064
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Royal Oak, Michigan 48073
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Salt Lake City, Utah 84132
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Santa Ana, California 92705
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Seattle, Washington 98109
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Silverdale, Washington 98383
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Sydney, New South Wales
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Traverse City, Michigan 49684
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Tucson, Arizona 85724
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Winter Haven, Florida 33880
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Winter Haven, FL
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