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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00733304




Registration number
NCT00733304
Ethics application status
Date submitted
12/08/2008
Date registered
13/08/2008
Date last updated
5/12/2017

Titles & IDs
Public title
An Extension to Study MD7108240
Scientific title
An Extension Study to Protocol MD7108240: Pazopanib Eye Drops in Subjects With Neovascular Age-related Macular Degeneration
Secondary ID [1] 0 0
MD7111396
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pazopanib

Experimental: 5 mg/ml TID - eligible participants received 5 mg/ml Pazopanib eye drops three times daily (TID)

Experimental: 2 mg/ml TID - eligible participants received 2 mg/ml Pazopanib eye drops three times daily

Experimental: 5 mg/ml QD - eligible participants received 5 mg/ml Pazopanib eye drops once daily (QD)


Treatment: Drugs: Pazopanib
5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period
Timepoint [1] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [2] 0 0
Change From Baseline (Day 1) in Heart Rate Over Period
Timepoint [2] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [3] 0 0
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Timepoint [3] 0 0
Baseline (Day 1), Month 2, 5 and approximately up to Month 6
Primary outcome [4] 0 0
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period
Timepoint [4] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [5] 0 0
Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period
Timepoint [5] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [6] 0 0
Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period
Timepoint [6] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [7] 0 0
Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period
Timepoint [7] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [8] 0 0
Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period
Timepoint [8] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [9] 0 0
Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period
Timepoint [9] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [10] 0 0
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Timepoint [10] 0 0
Baseline (Day 1) and approximately up to 6 months
Primary outcome [11] 0 0
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Timepoint [11] 0 0
Approximately up to 6 months (up to follow-up)
Primary outcome [12] 0 0
Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
Timepoint [12] 0 0
Approximately up to 6 months
Primary outcome [13] 0 0
Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)
Timepoint [13] 0 0
Approximately up to 6 months
Primary outcome [14] 0 0
Number of Participants With Abnormal Pupil Examination of PCI
Timepoint [14] 0 0
Up to follow-up (approximately 6 months)
Primary outcome [15] 0 0
Number of Participants With Abnormal Conjunctival Examination of PCI
Timepoint [15] 0 0
Up to follow-up (approximately 6 months)
Primary outcome [16] 0 0
Number of Participants With Abnormal Anterior Chamber Examination of PCI
Timepoint [16] 0 0
Approximately up to 6 months
Primary outcome [17] 0 0
Number of Participants With Abnormal Corneal Examination of PCI
Timepoint [17] 0 0
Approximately up to 6 months
Primary outcome [18] 0 0
Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale
Timepoint [18] 0 0
Approximately up to 6 months
Primary outcome [19] 0 0
Number of Participants With Abnormal Tear Films of PCI
Timepoint [19] 0 0
Approximately up to 6 months
Primary outcome [20] 0 0
Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function
Timepoint [20] 0 0
Approximately up to 6 months
Primary outcome [21] 0 0
Number of Participants With Abnormal (Dilated) Fundus Examination
Timepoint [21] 0 0
Approximately up to 6 months
Secondary outcome [1] 0 0
Change From Baseline (Screening Visit) in BCVA at Month 2 and 5
Timepoint [1] 0 0
From Baseline (screening visit), Month 2, and Month 5
Secondary outcome [2] 0 0
Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months
Timepoint [2] 0 0
From Baseline (Screening visit) and up to 5 months
Secondary outcome [3] 0 0
Change in Neo-vascular Size and Lesion Size Over Period
Timepoint [3] 0 0
Up to 6 weeks
Secondary outcome [4] 0 0
Number of Participants With Lesion Types Over Period
Timepoint [4] 0 0
Up to 6 months

Eligibility
Key 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.)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2009
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [3] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
2150 - Sydney
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Italy
State/province [7] 0 0
Lombardia
Country [8] 0 0
Italy
State/province [8] 0 0
Piemonte
Country [9] 0 0
Italy
State/province [9] 0 0
Toscana
Country [10] 0 0
Italy
State/province [10] 0 0
Veneto

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00733304