An Extension to Study MD7108240
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00733304
First received: August 12, 2008
Last updated: March 15, 2012
Last verified: March 2012
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Pazopanib
U.S. FDA Resources
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:
|
| Experimental: 2 mg/ml TID |
Drug: Pazopanib
eyedrops
Other Names:
|
| Experimental: 5 mg/ml QD |
Drug: Pazopanib
eyedrops
Other Names:
|
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
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 |
ClinicalTrials.gov processed this record on May 21, 2013