An Extension to Study MD7108240

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00733304
First received: August 12, 2008
Last updated: March 15, 2012
Last verified: March 2012
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 endpoints include ophthalmic examinations, vital signs (heart [ Time Frame: Throughout study 0- 5months ] [ Designated as safety issue: No ]

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 [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Change in visual acuity (number of letters read on standardized ETDRS charts). [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Change from baseline in central retinal/lesion thickness and changed in retinal morphology as measured by optical coherence tomography [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Change in enovascular size, lesion size and characteristics as measured by flourescein angiography and fundus photography. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: June 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 mg/ml TID Drug: Pazopanib
eyedrops
Other Names:
  • Pazopanib (5 mg/mL
  • TID) for 28 days
  • Pazopanib (2 mg/mL
  • QD) for 28 days
Experimental: 2 mg/ml TID Drug: Pazopanib
eyedrops
Other Names:
  • Pazopanib (5 mg/mL
  • TID) for 28 days
  • Pazopanib (2 mg/mL
  • QD) for 28 days
Experimental: 5 mg/ml QD Drug: Pazopanib
eyedrops
Other Names:
  • Pazopanib (5 mg/mL
  • TID) for 28 days
  • Pazopanib (2 mg/mL
  • QD) for 28 days

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733304

Locations
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90211
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, 46280
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02111
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48105
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
Australia, New South Wales
GSK Investigational Site
Sydney, New South Wales, Australia, 2150
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia, 6009
Italy
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Milano, Lombardia, Italy, 20132
GSK Investigational Site
Torino, Piemonte, Italy, 10122
GSK Investigational Site
Firenze, Toscana, Italy, 50134
GSK Investigational Site
Padova, Veneto, Italy, 35128
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00733304     History of Changes
Other Study ID Numbers: MD7111396
Study First Received: August 12, 2008
Last Updated: March 15, 2012
Health Authority: Italy: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014