Last updated: 11/03/2018 11:16:46
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Day 1 and 52 weeks
Secondary outcomes:
Percentage of ranibizumab re-injections received over 28 and 52 weeks
Timeframe: Up to 52 weeks
Number of participants with BCVA over time
Timeframe: Up to Week 52
Number of participants analyzed for Visual Acuity (VA) response over time
Timeframe: Week 52
Change from Baseline in center point thickness (CPT) over time
Timeframe: Baseline and Week 52
Number of Participants that met criteria for re-injection
Timeframe: Up to Week 52
Change from baseline in the area of choroidal neovascularisation (CNV)
Timeframe: Day 1, Week 28 and Week 52
Change from baseline in the area of the CNV lesion complex (i.e. CNV, blood, PED, and fibrosis)
Timeframe: Day 1, Week 28 and Week 52
Change from Baseline in the area of fluorescein leakage
Timeframe: Day 1, Week 28 and Week 52
Change in area of serous sensory retinal detachment (SSRD)
Timeframe: Day 1, Week 28 and Week 52
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 52 Weeks
Summary of Potentially Clinically Important Findings for Ophthalmic Examinations
Timeframe: Up to Week 52
Summary of Intraocular Pressure Exam Findings
Timeframe: Up to week 52
Number of Participants With Vital Sign Values Outside of Clinical Concern Range
Timeframe: Up to Week 52
Summary of abnormal Electrocardiogram (ECG) findings
Timeframe: Week 4, Week 28, Week 44 and Week 52
Summary of Hematology and Clinical Chemistry parameters data of Clinical Concern
Timeframe: Up to Week 52
Number of participants with Laboratory Data of Clinical Concern for Urine Protein
Timeframe: Day 1 to Week 28 and Week 52
Plasma concentrations of pazopanib
Timeframe: Week 4, Week 24 and Week 52
Interventions:
Drug: pazopanib eye drops
Drug: placebo
Biological/vaccine: ranibizumab intravitreal injection
Enrollment:
510
Observational study model:
Not applicable
Primary completion date:
2012-05-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Macular Degeneration
Product
pazopanib, ranibizumab
Collaborators
GSK
Study date(s)
June 2010 to October 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
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).
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.
Trial location(s)
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53705
Status
Study Complete
Location
GSK Investigational Site
Paducah, Kentucky, United States, 42001
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28803
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21287
Status
Study Complete
Location
GSK Investigational Site
Royal Oak, Michigan, United States, 48073
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92705
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92697
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53127
Status
Study Complete
Location
GSK Investigational Site
Sydney, New South Wales, Australia, 2000
Status
Study Complete
Location
GSK Investigational Site
Poway, California, United States, 92064
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 4X3
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10003
Status
Study Complete
Location
GSK Investigational Site
Silverdale, Washington, United States, 98383
Status
Study Complete
Location
GSK Investigational Site
Fort Myers, Florida, United States, 33901
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 3N9
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Loma Linda, California, United States, 92354
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98104
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Study Complete
Location
GSK Investigational Site
Sydney, New South Wales, Australia, 2150
Status
Study Complete
Location
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85020
Status
Study Complete
Location
GSK Investigational Site
Traverse City, Michigan, United States, 49686
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
Winter Haven, Florida, United States, 33880
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2012-05-10
Actual study completion date
2012-05-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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