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Macular DegenerationPhase 1NCT01154062

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

A Phase 1 study testing Pazopanib in people with Macular Degeneration, run by GlaxoSmithKline at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Macular Degeneration
What is being tested?
Pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
7 sitesUnited States
Study dates
16 Aug 2010to 29 Apr 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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%).

Who cannot join

  • 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.
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  • 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 4.4.1.2.
  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Grand Rapids, Michigan, 49525

  • GSK Investigational Site

    Indianapolis, Indiana, 46290

  • GSK Investigational Site

    Sacramento, California, 95819

  • GSK Investigational Site

    Sacramento, California, 95841

  • GSK Investigational Site

    Winter Haven, Florida, 33880

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Pazopanib
Keywords
age-related macular degeneration, pazopanib, choroidal neovascularization, GW786034
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Pazopanib tablet

Study groups in NCT01154062
Study groupRoleWhat they receive
low doseExperimentalPazopanib tablet
Receives: Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 month

Secondary outcomes (1)

  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)

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2010 (estimated)
  2. Study start16 Aug 2010
  3. Primary completion29 Apr 2011
  4. Study completion29 Apr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01154062
Sponsor's protocol ID
114155
Status last verified
Nov 2017
First submitted
29 Jun 2010
Last updated
9 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • McLaughlin MM, Paglione MG, Slakter J, Tolentino M, Ye L, Xu CF, Suttle AB, Kim RY. Initial exploration of oral pazopanib in healthy participants and patients with age-related macular degeneration. JAMA Ophthalmol. 2013 Dec;131(12):1595-601. doi: 10.1001/jamaophthalmol.2013.5002.

    PubMed 24113783

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pazopanib in people with Macular Degeneration, run by GlaxoSmithKline at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01154062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.

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