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A Study to Evaluate Pazopanib Tablets in Patients Who Have Neovascular Age-related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01154062
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : November 9, 2017
Information provided by (Responsible Party):

Brief Summary:
A study to evaluate pazopanib tablets in male and female adults of non-child bearing potential with subfoveal CNV due to neovascular AMD. The goal is to assess safety and how well the subjects tolerate the drug. The study will also look at how the body breaks down and metabolizes the drug. All subjects will start the study up to 8 days prior to receiving drug. Once started subjects will take one tablet each day for 28 days. A follow up visit will occur approximately 2 weeks after drug is stopped.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Pazopanib Phase 1

Detailed Description:

This is a multi-center, open label study of pazopanib administered for 28 days in adult patients with subfoveal CNV due to neovascular AMD. The primary aim is to evaluate safety and tolerability in patients with neovascular AMD and a secondary aim is to evaluate pharmacokinetics and pharmacodynamics. This study does not include a control treatment group (e.g. placebo or active comparator), and instead will be benchmarked to visual acuity and OCT changes observed following treatment with other anti-angiogenic agents in a similar patient population over the same treatment period.

All subjects will receive tablets administered once daily. Subjects will be screened within eight days prior to treatment assignment and initiation of study treatment. The duration of treatment will be 28 days, and subjects will participate in a baseline and four subsequent weekly study visits during the treatment phase. Subjects will also return for a follow-up visit approximately two weeks after last dose of study medication.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Pilot Study to Evaluate the Safety, Tolerability,Pharmacokinetics, Exploratory Efficacy and Pharmacodynamics of Oral Pazopanib Administered for 28 Days to Neovascular Age-relatedmacular Degeneration Patients
Actual Study Start Date : August 16, 2010
Actual Primary Completion Date : April 29, 2011
Actual Study Completion Date : April 29, 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Pazopanib

Arm Intervention/treatment
Experimental: low dose
Pazopanib tablet
Drug: Pazopanib
Pazopanib tablet

Primary Outcome Measures :
  1. Safety endpoints include complete ophthalmic examination, visual acuity, vital signs (heart rate and blood pressure), clinical laboratory tests, clinical monitoring and adverse event reporting [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Changes in visual acuity, central retinal thickness, central retinal lesion thickness, retinal morphology, neovascular size, lesion size, and characteristics by fluoresceinangiography and fundus photography. Also, (CL/F), (V/F), (Ka), and (Cτ) [ Time Frame: 1 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye, with all of the following characteristics required and confirmed by a central reading center:

    • CNV caused by AMD that extends under the geometric center of the foveal avascular zone
    • CNV comprises ≥ 50% of lesion area
    • Total lesion area no greater than 12 disc areas on fluorescein angiography, where the lesion complex includes CNV, blood, blocked fluorescence not from blood, and serous detachment of the retinal pigment epithelium
    • classic CNV comprises <50% of the lesion area
    • fibrosis comprises ≤ 25% of lesion area
    • Center subfield > 320 microns on SD-OCT (inclusive of subretinal fluid)
    • if no evidence of classic CNV, then presumed to have recent disease progression because of deterioration (≥ 5 letter decrease in vision or evidence of growth of a CNV lesion on fluorescein angiography ) within last 3 months or evidence of hemorrhage from CNV
  • Best-corrected ETDRS visual acuity score in the study eye of between 25 and 73 letters (approximately equivalent to Snellen VA of 20/320 to 20/32) at screening.
  • Male or female ≥ 50 years of age.
  • A female subject is eligible to participate if she is of non-childbearing potential defined as either pre-menopausal with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases of postmenopausal status a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) or value consistent with local laboratory recommended value is confirmatory.
  • Subject is willing and able to return for all study visits, and is willing and able to comply with all protocol requirements and procedures.
  • Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is unable to read the consent form due to visual impairment then the consent must be read to the subject verbatim by person administering the consent, a family member or legally acceptable representative. (Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)
  • QTcF <450msec; or QTcF<480msec in subjects with Bundle Branch Block.
  • AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

Exclusion Criteria:

  • Additional eye disease in the study eye that could compromise best-corrected visual acuity (e.g. glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, infection or retinitis pigmentosa).
  • CNV in the study eye due to other causes unrelated to age-related macular degeneration.
  • The presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required).
  • Geographic atrophy involving the center of the fovea in the study eye.
  • Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and SD-OCT.
  • Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD. Any previous treatment in the study eye for neovascular AMD, approved or investigational.
  • Current intravitreal anti-VEGF therapy in the fellow eye.
  • Within 6 months prior to the Screening Visit, use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib), approved or investigational.
  • Intraocular surgery in the study eye within 3 months of dosing.
  • Aphakia or total absence of the posterior capsule (Yttrium aluminum garnet (YAG) capsulotomy permitted) in the study eye.
  • History of vitrectomy in the study eye.
  • Presence of RPE tear in the study eye.
  • Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with anti-glaucoma medication.
  • Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol).
  • Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

Medical history or unresolved medical condition, for example:

  • Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%
  • Myocardial infarction or stroke within 6 months of screening
  • Active bleeding disorder
  • Major surgery within 3 months of screening
  • Hepatic impairment
  • Clinically relevant thyroid disease

    • Uncontrolled hypertension, based on criteria provided in Section
    • Subject has a history within the past 2 years of alcohol, substance abuse, or psychiatric disorder likely to confound the efficacy or safety assessments. A history of known HIV infection.
    • Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to the first dose of study medication.
    • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
    • A condition or situation, which, in the opinion of the investigator, may result in significant risk to the patient, confound the study results or interfere significantly with participation.
    • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01154062

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United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90211
GSK Investigational Site
Sacramento, California, United States, 95819
GSK Investigational Site
Sacramento, California, United States, 95841
United States, Florida
GSK Investigational Site
Winter Haven, Florida, United States, 33880
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46290
United States, Michigan
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline Identifier: NCT01154062    
Other Study ID Numbers: 114155
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Keywords provided by GlaxoSmithKline:
age-related macular degeneration
choroidal neovascularization
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases