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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00612456




Registration number
NCT00612456
Ethics application status
Date submitted
29/01/2008
Date registered
11/02/2008
Date last updated
20/11/2017

Titles & IDs
Public title
To Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD
Scientific title
A Double-masked, Randomized, Parallel-group Study to Investigate the Pharmacodynamics, Safety, and Systemic Pharmacokinetics of Pazopanib Drops, Administered for 28 Days to Adult Subjects With Neovascular Age-related Macular Degeneration.
Secondary ID [1] 0 0
MD7108240
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: Arm 1 - Pazopanib eye drops formulation 5 mg/mL daily for 28 days

Experimental: Arm 2 - Pazopanib eye drop formulation 5mg/mL TID for 28 days

Experimental: Arm 3 - Pazopanib eye drop formulation 2mg/mL TID for 28 days


Treatment: Drugs: Pazopanib
Pazopanib eye drops formulation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in Central Retinal/Lesion Thickness (CRLT) as Measured by the Carl Zeiss Meditec Stratus Optical Coherence Tomography (OCT) Scanner at Day 29
Timepoint [1] 0 0
Baseline (Day -3 to -1) and Day 29
Secondary outcome [1] 0 0
Number of Participants With Complete Ophthalmic Examination Values of Potential Clinical Concern
Timepoint [1] 0 0
Upto follow-up (Day 43)
Secondary outcome [2] 0 0
Number of Participants With Vital Sign Data for Systolic Blood Pressure and Diastolic Blood Pressure and Heart Rate of Potential Clinical Concern
Timepoint [2] 0 0
Up to follow up (Day 46)
Secondary outcome [3] 0 0
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Timepoint [3] 0 0
Day 15 and follow-up (Day 43)
Secondary outcome [4] 0 0
Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern
Timepoint [4] 0 0
Up to follow-up Day 43
Secondary outcome [5] 0 0
Number of Participants With Abnormal Urinalysis Data by Dipstick Analysis
Timepoint [5] 0 0
Day 29 and follow-up (Day 43)
Secondary outcome [6] 0 0
Number of Participants With Ocular Adverse Events, Non-ocular Adverse Events, Serious Ocular Adverse Events and Serious Non-ocular Adverse Events
Timepoint [6] 0 0
Up to follow-up (Day 43)
Secondary outcome [7] 0 0
Change From Baseline in Best Corrected Visual Acuity (BCVA) [Number of Letter Read on Standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) Charts at Day 29
Timepoint [7] 0 0
Baseline (Day -3 to -1) and Day 29
Secondary outcome [8] 0 0
Number of Participants With Change in Retinal Morphology (Cystoid Spaces, Subretinal Fluid and Retinal Pigment Epithelial Detachment) as Determined by OCT
Timepoint [8] 0 0
Day 29
Secondary outcome [9] 0 0
Number of Participants With Change in Characteristics (Fibrosis, Atrophy, Blood) as Measured by Fundus Photography (FP)
Timepoint [9] 0 0
Day 29
Secondary outcome [10] 0 0
Change From Baseline in Neovascular Size, Total Lesion Size, Fluorescein Angiography (FA) Leakage Area of Measurement, FA Blood Area of Measurement as Measured by FA at Day 29
Timepoint [10] 0 0
Baseline (Day -3 to -1) and Day 29
Secondary outcome [11] 0 0
Plasma Pharmacokinetic Parameter Maximum Observed Concentration (Cmax)
Timepoint [11] 0 0
Day 15 and Day 22
Secondary outcome [12] 0 0
Plasma Pharmacokinetic Parameter Time of Occurrence of Cmax (Tmax)
Timepoint [12] 0 0
Day 15 and Day 22
Secondary outcome [13] 0 0
Plasma Pharmacokinetic Parameter Area Under Concentration Time-curve From Time Zero to 6 Hours (AUC [0-6)]
Timepoint [13] 0 0
Day 15 and Day 22

Eligibility
Key inclusion criteria
* Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye, with all of the following characteristics required:

* central subfield thickness > 300 microns on investigator-determined OCT (inclusive of subretinal fluid)
* active subfoveal leakage as determined by investigator-determined fluorescein angiography
* minimally classic or occult with no classic CNV lesion
* lesion size no greater than 12 disc areas
* CNV > 50% of lesion area
* < 50% of lesion area with blood
* = 25% of lesion area with fibrosis
* Best-corrected ETDRS visual acuity in the study eye between 80 to 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 to 4/63) at screening
* Female subjects must be of non-childbearing potential.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Additional eye disease in the study eye that could compromise best corrected visual acuity (i.e. glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, or retinitis pigmentosa).
* CNV in the study eye due to other causes unrelated to age-related macular degeneration.
* The presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required).
* Geographic atrophy involving the center of the fovea in the study eye.
* 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.
* More than one prior photodynamic therapy (PDT) treatment in the study eye.
* PDT treatment in the study eye < 12 weeks prior to dosing.
* Previous treatment in the study eye with ranibizumab (Lucentis) or bevacizumab (Avastin) without resolution of exudation (intraretinal and subretinal fluid as documented by OCT).
* Use of any treatment, either approved or experimental, for AMD in the study eye within 60 days of first dose of investigational product.
* Intraocular surgery in the study eye within 3 months of dosing.
* Aphakia or total absence of the posterior capsule (Yttrium aluminum garnet (YAG) capsulotomy permitted) in the study eye.
* History of vitrectomy in the study eye.
* Use of topical ocular medications 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 (refer to Section 9.1)
* Active treatment in the fellow eye, with the exception of preservative-free 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).
* Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose.
* An unwillingness to refrain from wearing contact lenses starting from the screening visit, through the follow-up visit
* Medical history or condition:

* Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%.
* Myocardial infarction or stroke within 12 months of screening.
* Active bleeding disorder.
* Major surgery within 1 month of screening.
* Hepatic impairment.
* Uncontrolled hypertension

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
5/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/06/2009
Sample size
Target
Accrual to date
Final
70
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
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Italy
State/province [13] 0 0
Friuli-Venezia-Giulia
Country [14] 0 0
Italy
State/province [14] 0 0
Lombardia
Country [15] 0 0
Italy
State/province [15] 0 0
Piemonte
Country [16] 0 0
Italy
State/province [16] 0 0
Toscana
Country [17] 0 0
Italy
State/province [17] 0 0
Veneto

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a 28 day study to evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients
Trial website
https://clinicaltrials.gov/study/NCT00612456
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00612456