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An Extension to Study MD7108240
This study is currently recruiting participants.
Verified by GlaxoSmithKline, August 2009
First Received: August 12, 2008   Last Updated: August 13, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00733304
  Purpose

This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months.


Condition Intervention Phase
Macular Degeneration
Drug: Pazopanib (5 mg/mL, TID) for 28 days,Pazopanib (2 mg/mL, TID) for 28 days,Pazopanib (5 mg/mL, QD) for 28 days
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study
Official Title: An Extension Study to Protocol MD7108240: Pazopanib Eye Drops in Subjects With Neovascular Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety and tolerability by ophthalmic examinations, vital signs, clinical laboratory tests performed monthly and AE reporting

Secondary Outcome Measures:
  • Change in: visual acuity, central retinal thickness retinal morphology measured by OCT an imaging technique measured monthly, neovascular size lesion size, characteristics fibrosis atrophy blood measured fundus photography, fluorescein angiography
  • Change in visual acuity (number of letters read on standardized ETDRS charts).
  • Change from baseline in central retinal/lesion thickness and changed in retinal morphology as measured by optical coherence tomography
  • Change in enovascular size, lesion size and characteristics as measured by flourescein angiography and fundus photography.

Estimated Enrollment: 99
Study Start Date: June 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who participated in Phase IIa study MD7108240 and who did not experience AMD disease progression requiring rescue therapy during pazopanib treatment or require discontinuation of pazopanib eye drops for safety reasons
  • Best-corrected ETDRS visual acuity in the study eye of 23 letters (20/320 or 4/63) or better at screening.
  • QTcB or QTcF < 450msec; or QTc < 480msec in subjects with Bundle Branch Block.
  • 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.)

Exclusion Criteria:

  • 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.
  • Intraocular surgery in the study eye within 3 months of dosing.
  • Use of topical ocular medications (other than pazopanib) 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.
  • 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).
  • An unwillingness to refrain from wearing contact lenses starting from the screening visit, through the follow-up visit
  • ALT or AST above the upper limit of normal or total bilirubin ≥ 1.5 times the upper limit of normal at baseline. Note: Laboratory tests outside of the normal range may be repeated at the discretion of the Investigator.
  • Medical history or condition:
  • Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%.
  • Myocardial infarction or stroke within 6 months of screening.
  • Active bleeding disorder.
  • Major surgery within 1 month of screening.
  • Hepatic impairment.
  • Uncontrolled hypertension, based on criteria provided in the protocol. Note: Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided the referenced criteria are met.
  • Use of prohibited medications listed in the protocol within the restricted timeframe relative to the first dose of study medication.
  • A condition or situation which, in the opinion of the investigator, may result in significant risk to the subject, confound the study results or interfere significantly with participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733304

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

  Show 23 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: MD7111396
Study First Received: August 12, 2008
Last Updated: August 13, 2009
ClinicalTrials.gov Identifier: NCT00733304     History of Changes
Health Authority: United States: Food and Drug Administration;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Italy: Ministry of Health

Keywords provided by GlaxoSmithKline:
pazopanib
age-related macular degeneration (AMD)
choroidal neovascularization (CNV)
vascular endothelial growth factor (VEGF)
angiogenesis

Study placed in the following topic categories:
Eye Diseases
Mitogens
Retinal Degeneration
Macular Degeneration
Tetrahydrozoline
Neovascularization, Pathologic
Endothelial Growth Factors
Retinal Diseases
Choroidal Neovascularization

Additional relevant MeSH terms:
Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on August 26, 2009