Last updated: 11/07/2018 17:35:24

To evaluate the pharmacodynamics, safety, and pharmacokinetics of pazopanib drops in adult subjects with neovascular AMDN/A

GSK study ID
MD7108240
See study documents
Clinicaltrials.gov ID
NCT00612456
See results summary
EudraCT ID
2007-006073-84
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A double-masked, randomized, parallel-group study to investigate the pharmacodynamics, safety, and systemic pharmacokinetics of pazopanib drops, administered for 28 days to adult subjects with neovascular age-related macular degeneration.
Trial description: This is a 28 day study to evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline in central retinal/lesion thickness (CRLT) as measured by the Carl Zeiss Meditec Stratus optical coherence tomography (OCT) scanner at Day 29

Timeframe: Baseline (Day -3 to -1) and Day 29

Secondary outcomes:

Number of participants with complete ophthalmic examination values of potential clinical concern

Timeframe: Upto follow-up (Day 43)

Number of participants with vital sign data for systolic blood pressure and diastolic blood pressure and heart rate of potential clinical concern

Timeframe: Up to follow up (Day 46)

Number of participants with abnormal 12-lead electrocardiogram (ECG) findings

Timeframe: Day 15 and follow-up (Day 43)

Number of participants with clinical chemistry and hematology data of potential clinical concern

Timeframe: Up to follow-up Day 43

Number of participants with abnormal urinalysis data by dipstick analysis

Timeframe: Day 29 and follow-up (Day 43)

Number of participants with ocular adverse events, non-ocular adverse events, serious ocular adverse events and serious non-ocular adverse events

Timeframe: Up to follow-up (Day 43)

Change from Baseline in best corrected visual acuity (BCVA) [number of letter read on standardized early treatment of diabetic retinopathy study (ETDRS) charts at Day 29

Timeframe: Baseline (Day -3 to -1) and Day 29

Number of participants with change in retinal morphology (cystoid spaces, subretinal fluid and retinal pigment epithelial detachment) as determined by OCT

Timeframe: Day 29

Number of participants with change in characteristics (fibrosis, atrophy, blood) as measured by fundus photography (FP)

Timeframe: Day 29

Change from Baseline in neovascular size, total lesion size, fluorescein angiography (FA) leakage area of measurement, FA blood area of measurement as measured by FA at Day 29

Timeframe: Baseline (Day -3 to -1) and Day 29

Plasma pharmacokinetic parameter maximum observed concentration (Cmax)

Timeframe: Day 15 and Day 22

Plasma pharmacokinetic parameter time of occurrence of Cmax (tmax)

Timeframe: Day 15 and Day 22

Plasma pharmacokinetic parameter area under concentration time-curve from time zero to 6 hours (AUC [0-6)]

Timeframe: Day 15 and Day 22

Interventions:
  • Drug: Pazopanib
    • Enrollment:
    70
    Primary completion date:
    2009-27-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Danis R, McLaughlin M, Tolentino M, Staurenghi G, Ye L, Xu C-F, Kim R, Johnson M.Pazopanib Eye Drops: a Randomized Trial in Neovascular Age Related Macular Degeneration.Br J Ophthalmol.2014;98(2):172-178
    Medical condition
    Macular Degeneration
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    March 2008 to January 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • 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)
    • 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.
    Inclusion and exclusion criteria
    Inclusion criteria:

      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 CNV lesion
      • lesion size no greater than 12 disc areas
      • CNV > 50% of lesion area
      • < 50% of lesion area with blood
      • = 25% of lesion area with fibrosis
    • Best-corrected ETDRS visual acuity in the study eye between 80 to 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 to 4/63) at screening
    • Female subjects must be of non-childbearing potential.
    Exclusion criteria:
    • 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.
    • 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 (refer to Section 9.1)
    • 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. 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.
    • 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

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Melbourne, Victoria, Australia
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sydney, New South Wales, Australia, 2150
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Grand Rapids, Michigan, United States, 49525
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78705
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ft. Lauderdale, Florida, United States, 33334
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Sacramento, California, United States, 95841
    Status
    Study Complete
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    Showing 1 - 6 of 27 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-27-01
    Actual study completion date
    2009-27-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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