Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2008-06-25
2009-09-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
5 mg/ml TID
eligible participants received 5 mg/ml Pazopanib eye drops three times daily (TID)
Pazopanib
5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
2 mg/ml TID
eligible participants received 2 mg/ml Pazopanib eye drops three times daily
Pazopanib
5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
5 mg/ml QD
eligible participants received 5 mg/ml Pazopanib eye drops once daily (QD)
Pazopanib
5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pazopanib
5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Winter Haven, Florida, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Ann Arbor, Michigan, United States
GSK Investigational Site
Grand Rapids, Michigan, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Sydney, New South Wales, Australia
GSK Investigational Site
Sydney, New South Wales, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Perth, Western Australia, Australia
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Turin, Piedmont, Italy
GSK Investigational Site
Florence, Tuscany, Italy
GSK Investigational Site
Padua, Veneto, Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MD7111396
Identifier Type: -
Identifier Source: org_study_id