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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01134055




Registration number
NCT01134055
Ethics application status
Date submitted
27/05/2010
Date registered
31/05/2010
Date last updated
8/01/2018

Titles & IDs
Public title
Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
Scientific title
MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops Versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration
Secondary ID [1] 0 0
110852
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 eye drops
Treatment: Drugs - placebo
Treatment: Other - ranibizumab intravitreal injection

Experimental: investigational arm 1 - 5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection

Experimental: investigational arm 2 - 5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection

Experimental: investigational arm 3 - 10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection

Experimental: investigational arm 4 - 10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection

Experimental: investigational arm 5 - 10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection

Placebo comparator: placebo control arm - Placebo eye drops QID with allowance for as-needed ranibizumab injection

Active comparator: active open-label control arm - Ranibizumab intravitreal injection every 4 weeks


Treatment: Drugs: pazopanib eye drops
A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.

Treatment: Drugs: placebo
placebo eye drops

Treatment: Other: ranibizumab intravitreal injection
Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52
Timepoint [1] 0 0
Day 1 and 52 weeks
Secondary outcome [1] 0 0
Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [2] 0 0
Number of Participants With BCVA Over Time
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [3] 0 0
Number of Participants Analyzed for Visual Acuity (VA) Response Over Time
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Change From Baseline in Center Point Thickness (CPT) Over Time
Timepoint [4] 0 0
Baseline and Week 52
Secondary outcome [5] 0 0
Number of Participants That Met Criteria for Re-injection
Timepoint [5] 0 0
Up to Week 52
Secondary outcome [6] 0 0
Change From Baseline in the Area of Choroidal Neovascularisation (CNV)
Timepoint [6] 0 0
Day 1, Week 28 and Week 52
Secondary outcome [7] 0 0
Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis)
Timepoint [7] 0 0
Day 1, Week 28 and Week 52
Secondary outcome [8] 0 0
Change From Baseline in the Area of Fluorescein Leakage
Timepoint [8] 0 0
Day 1, Week 28 and Week 52
Secondary outcome [9] 0 0
Change in Area of Serous Sensory Retinal Detachment (SSRD)
Timepoint [9] 0 0
Day 1, Week 28 and Week 52
Secondary outcome [10] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [10] 0 0
Up to 52 Weeks
Secondary outcome [11] 0 0
Summary of Potentially Clinically Important Findings for Ophthalmic Examinations
Timepoint [11] 0 0
Up to Week 52
Secondary outcome [12] 0 0
Summary of Intraocular Pressure Exam Findings
Timepoint [12] 0 0
Up to week 52
Secondary outcome [13] 0 0
Number of Participants With Vital Sign Values Outside of Clinical Concern Range
Timepoint [13] 0 0
Up to Week 52
Secondary outcome [14] 0 0
Summary of Abnormal Electrocardiogram (ECG) Findings
Timepoint [14] 0 0
Week 4, Week 28, Week 44 and Week 52
Secondary outcome [15] 0 0
Summary of Hematology and Clinical Chemistry Parameters Data of Clinical Concern
Timepoint [15] 0 0
Up to Week 52
Secondary outcome [16] 0 0
Number of Participants With Laboratory Data of Clinical Concern for Urine Protein
Timepoint [16] 0 0
Day 1 to Week 28 and Week 52
Secondary outcome [17] 0 0
Plasma Concentrations of Pazopanib
Timepoint [17] 0 0
Week 4, Week 24 and Week 52

Eligibility
Key inclusion criteria
* Men and women aged =50 years.
* Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study eye: Total lesion area =12 disc areas with CNV =50% total lesion area.
* Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and in need of re-treatment.
* Best-corrected visual acuity of at least 24 letters (equates to approximately 20/320 Snellen equivalents or better).
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior ocular investigational drug/device for choroidal neovascularization, photodynamic therapy, radiation, subfoveal or juxtafoveal focal laser photocoagulation.
* Prior failure to anti-VEGF intravitreal injection therapy.
* Recent ocular investigational drug/device for non-CNV condition.
* Prior ocular surgeries (vitrectomy, scleral buckle, or glaucoma filtering/shunt surgery). Cataract surgery permitted if =3 months and has posterior chamber intraocular lens.
* Center-fovea involvement of any of the following: fibrosis, atrophy, serous retinal pigment epithelial detachment, or retinal pigment epithelial tear.
* CNV in either eye due to other causes.
* Clinical evidence of diabetic retinopathy or diabetic macular edema.
* Recent myocardial infarction or cerebrovascular accident.
* Uncontrolled hypertension in spite of antihypertensive medications.

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 administering the treatment/s
The people assessing the outcomes
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
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
510
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 - Nedlands
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2150 - Sydney
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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Colorado
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Florida
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Illinois
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Michigan
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Texas
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Utah
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Washington
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United States of America
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Wisconsin
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Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Liège
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
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Denmark
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Aarhus
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Denmark
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Glostrup
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Italy
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Friuli-Venezia-Giulia
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Italy
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Lombardia
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Italy
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Piemonte
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Veneto
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Aichi
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Chiba
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Fukuoka
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Fukushima
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Hokkaido
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Kagawa
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Tokyo
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Sweden
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Linköping
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Sweden
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Stockholm
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Sweden
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Uppsala
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Sweden
State/province [46] 0 0
Örebro

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.
Trial website
https://clinicaltrials.gov/study/NCT01134055
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/NCT01134055