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AzTrials

Macular DegenerationPhase 1NCT00463320

A Study To Evaluate The Safety, Tolerability And Pk Of Pazopanib Eye Drops In Healthy Adult And Elderly Subjects.

A Phase 1 study testing Pazopanib eye drops and Allergen Refresh Plus eye drops in people with Macular Degeneration and Age-related Macular Degeneration, run by GlaxoSmithKline at 2 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

This is a two-part study to evaluate the safety, tolerability and pharmacokinetics of single (Part A) and repeat (Part B) eye drop doses of pazopanib in healthy adult and elderly subjects. Read more about this study

Who is it for?
Ages 30 to 55 yearsHealthy volunteers can take part
What is being tested?
Pazopanib eye drops and Allergen Refresh Plus eye drops
How many people
29 participants
Where
2 sitesUnited States
Study dates
Mar 2007to Aug 2007
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 30 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • 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:
  • central subfield thickness > 300 microns on investigator-determined OCT (inclusive of subretinal fluid);
  • active subfoveal leakage as determined by investigator-determined fluorescein angiography;
  • minimally classic or occult with no classic D8 lesion;
  • lesion size no greater than 12 disc areas;
  • CNV> 50% of lesion area;
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  • < 50% of lesion area with blood;
  • ≤ 25% of lesion area with fibrosis.
  • Male or female 50 years of age.
  • Best-corrected ETDRS visual acuity in the study eye between 80 to 24 letters inclusive (approximately 20/25 to 20/320 or 4/5 to 4/63) at screening.
  • 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) 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. If the subject is unable to provide written informed consent due to visual impairment, then written informed consent on behalf of the subject must be provided by a legally acceptable representative.
  • (Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)

Who cannot join

  • Additional eye disease in the study eye that could compromise best corrected visual acuity (i.e. glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, 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 OCT.
  • Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD.
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  • More than one prior photodynamic therapy (PDT) treatment in the study eye.
  • PDT treatment in the study eye < 12 weeks prior to dosing.
  • Previous treatment in the study eye with ranibizumab (Lucentis) or bevacizumab (Avastin) without resolution of exudation (intraretinal and subretinal fluid as documented by OCT).
  • Use of any treatment, either approved or experimental, for AMD in the study eye within 60 days of first dose of investigational product.
  • 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.
  • Use of topical ocular medications in the study eye within 7 days of first dose of investigational product or expected use of topical ocular medications during the treatment period, with the exception of artificial tears
  • Active treatment in the fellow eye, with the exception of preservative-free artificial tears.
  • Current use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoxamine, chloroquine/hydroxychloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol).
  • Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose.
  • An unwillingness to refrain from wearing contact lenses starting from the screening visit, through the follow-up visit
  • Medical history or condition:
  • Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%.
  • Myocardial infarction or stroke within 12 months of screening.
  • Active bleeding disorder.
  • Major surgery within 1 month of screening.
  • Hepatic impairment.
  • Uncontrolled hypertension, based on criteria provided in Section 7.2.2. Note: Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided the referenced criteria are met.
  • ALT or AST above the upper limit of normal or total bilirubin values at or above 1.5 times the upper limit of normal at screening..
  • Note: Laboratory tests outside of the normal range may be repeated at the discretion of the Investigator.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.
  • A history of known HIV infection.
  • Use of prohibited medications listed in within the restricted timeframe relative to the first dose of study medication.
  • History of drug or alcohol abuse within 6 months of the study.
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • GSK Investigational Site

    Austin, Texas, 78744

  • GSK Investigational Site

    Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: A Placebo-controlled, Randomized, Dose Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Ocular Doses of Pazopanib in Healthy Adult and Elderly Subjects.

This is a two-part study to evaluate the safety, tolerability and pharmacokinetics of single (Part A) and repeat (Part B) eye drop doses of pazopanib in healthy adult and elderly subjects.

Being tested
Pazopanib eye drops and Allergen Refresh Plus eye drops
Keywords
Age-related macular degeneration (AMD),, vascular endothelial growth factor (VEGF)receptor (VEGFR), choroidal neovascularization,
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.

  • Pazopanib eye drops and Allergen Refresh Plus eye dropsDrug

What is being measured

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

  1. Ocular safety by observation and eye exams.

    Measured: at baseline, each dosing day and follow-up

  2. General safety by PE, VS, cardiac monitoring, clinical laboratory tests and adverse events reporting .

    Measured: day-1,5,10,14

  3. Pazopanib exposure by AUC and Cmax .

    Measured: day 1,14

Secondary outcomes (6)

  1. Pazopanib exposure measured by secondary pharmacokinetic parameters at day 1 and 14.

  2. Safety endpoints include complete ophthalmic examination, vital signs (heart rate and blood pressure), cardiac monitoring (electrocardiogram), clinical laboratory tests, clinical monitoring and adverse event reporting.

  3. Change in visual acuity (number of letters read on standardized ETDRS charts).

  4. Change in retinal morphology (i.e. CNV, intraretinal cysts, intraretinal fluid, subretinal fluid, and retinal pigment epithelial detachment) as determined by OCT.

  5. Change in neovascular size, lesion size and characteristics (fibrosis, atrophy, blood) as measured by fluorescein angiography and fundus photography.

  6. Cmax, tmax, and AUC(0-24) of plasma pazopanib, if data are sufficient.

Timeline

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

  1. First posted20 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Study completionAug 2007

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00463320
Sponsor's protocol ID
MD7108238
Status last verified
Feb 2011
First submitted
18 Apr 2007
Last updated
19 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pazopanib eye drops and Allergen Refresh Plus eye drops in people with Macular Degeneration and Age-related Macular Degeneration, run by GlaxoSmithKline at 2 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 14 inclusion and 33 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 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Ocular safety by observation and eye exams. (time frame: at baseline, each dosing day and follow-up). The study lists 3 primary outcomes in all. 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 NCT00463320.

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 19 Mar 2012.

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