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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
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
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
Country [25] 0 0
Denmark
State/province [25] 0 0
Aarhus
Country [26] 0 0
Denmark
State/province [26] 0 0
Glostrup
Country [27] 0 0
Germany
State/province [27] 0 0
Baden-Wuerttemberg
Country [28] 0 0
Germany
State/province [28] 0 0
Bayern
Country [29] 0 0
Germany
State/province [29] 0 0
Nordrhein-Westfalen
Country [30] 0 0
Germany
State/province [30] 0 0
Sachsen
Country [31] 0 0
Germany
State/province [31] 0 0
Schleswig-Holstein
Country [32] 0 0
Italy
State/province [32] 0 0
Friuli-Venezia-Giulia
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Italy
State/province [34] 0 0
Piemonte
Country [35] 0 0
Italy
State/province [35] 0 0
Veneto
Country [36] 0 0
Japan
State/province [36] 0 0
Aichi
Country [37] 0 0
Japan
State/province [37] 0 0
Chiba
Country [38] 0 0
Japan
State/province [38] 0 0
Fukuoka
Country [39] 0 0
Japan
State/province [39] 0 0
Fukushima
Country [40] 0 0
Japan
State/province [40] 0 0
Hokkaido
Country [41] 0 0
Japan
State/province [41] 0 0
Kagawa
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Sweden
State/province [43] 0 0
Linköping
Country [44] 0 0
Sweden
State/province [44] 0 0
Stockholm
Country [45] 0 0
Sweden
State/province [45] 0 0
Uppsala
Country [46] 0 0
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
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/NCT01134055