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

Completed · Phase 2 · Has a placebo group

Conditions studied: Macular Degeneration

In brief

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.

Key facts

Study ID

NCT01134055

Run by

GlaxoSmithKline

People needed

510

Starts

2010-06-01

Expected to finish

2012-10-01

Last updated by the study team

2018-01-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — Loma Linda, California, United States
• GSK Investigational Site — Poway, California, United States
• GSK Investigational Site — Santa Ana, California, United States
• GSK Investigational Site — Golden, Colorado, United States
• GSK Investigational Site — Fort Myers, Florida, United States
• GSK Investigational Site — Winter Haven, Florida, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Leawood, Kansas, United States
• GSK Investigational Site — Paducah, Kentucky, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Royal Oak, Michigan, United States
• GSK Investigational Site — Traverse City, Michigan, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Asheville, North Carolina, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Beachwood, Ohio, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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