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
sites
Austin, Texas 78705
515
mi
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Austin, TX
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Asheville, North Carolina 28803
859
mi
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Asheville, NC
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Ashland, Oregon 97520
1347
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Ashland, OR
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Baltimore, Maryland 21201
1148
mi
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Baltimore, MD
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Beachwood, Ohio 44122
903
mi
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Beachwood, OH
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Boston, Massachusetts 02115
1444
mi
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Boston, MA
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Chapel Hill, North Carolina 27599
1043
mi
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Chapel Hill, NC
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Charlotte, North Carolina 28203
957
mi
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Charlotte, NC
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Chicago, Illinois 60611
611
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Chicago, IL
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Cleveland, Ohio 44195
898
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Cleveland, OH
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Columbus, Ohio 43219
815
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Columbus, OH
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Dallas, Texas 75230
340
mi
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Dallas, TX
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Fort Myers, Florida 33916
1207
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Fort Myers, FL
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Fort Worth, Texas 76104
348
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Fort Worth, TX
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Golden, Colorado 80401
421
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Golden, CO
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Irvine, California 92697
1156
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Irvine, CA
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Leawood, Kansas 66211
190
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Leawood, KS
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Loma Linda, California 92357
1114
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Loma Linda, CA
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Madison, Wisconsin 53792
574
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Madison, WI
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New York, New York 10032
1290
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New York, NY
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Paducah, Kentucky 42001
507
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Paducah, KY
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Peoria, Arizona 85381
856
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Peoria, AZ
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Philadelphia, Pennsylvania 19104
1223
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Philadelphia, PA
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Phoenix, Arizona 85012
850
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Portland, Oregon 97227
1384
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Poway, California 92064
1129
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Royal Oak, Michigan 48073
840
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Royal Oak, MI
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Salt Lake City, Utah 84132
777
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Salt Lake City, UT
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Santa Ana, California 92705
1155
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Santa Ana, CA
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Seattle, Washington 98109
1411
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Seattle, WA
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Silverdale, Washington 98383
1427
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Sydney, New South Wales
8648
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Sydney,
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Traverse City, Michigan 49684
796
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Traverse City, MI
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Tucson, Arizona 85724
833
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Tucson, AZ
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Winter Haven, Florida 33880
1147
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Winter Haven, FL
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