Clinical trial NCT01134055: Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: ranibizumab
wet AMD
MD7110852
age related macular degeneration
age-related macular degeneration
macular degeneration
pazopanib
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 510
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: MD7110852 is a Phase 2b dose-ranging study designed to demonstrate the 1 year efficacy and safety of pazopanib eye drops for the treatment of neovascular age related macular degeneration (AMD) in subjects whose disease is currently managed with anti-VEGF (vascular endothelial growth factor) injection therapy. Eye drop regimens are double-masked with placebo eye drops and will have access to open-label ranibizumab intravitreal (IVT) injection if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.

Eligibility 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.

Primary outcomes:
measure: 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:
measure: Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks
timeFrame: Up to 52 weeks
measure: Number of Participants With BCVA Over Time
timeFrame: Up to Week 52
measure: Number of Participants Analyzed for Visual Acuity (VA) Response Over Time
timeFrame: Week 52
measure: Change From Baseline in Center Point Thickness (CPT) Over Time
timeFrame: Baseline and Week 52
measure: Number of Participants That Met Criteria for Re-injection
timeFrame: Up to Week 52
measure: Change From Baseline in the Area of Choroidal Neovascularisation (CNV)
timeFrame: Day 1, Week 28 and Week 52
measure: 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
measure: Change From Baseline in the Area of Fluorescein Leakage
timeFrame: Day 1, Week 28 and Week 52
measure: Change in Area of Serous Sensory Retinal Detachment (SSRD)
timeFrame: Day 1, Week 28 and Week 52
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 52 Weeks
measure: Summary of Potentially Clinically Important Findings for Ophthalmic Examinations
timeFrame: Up to Week 52
measure: Summary of Intraocular Pressure Exam Findings
timeFrame: Up to week 52
measure: Number of Participants With Vital Sign Values Outside of Clinical Concern Range
timeFrame: Up to Week 52
measure: Summary of Abnormal Electrocardiogram (ECG) Findings
timeFrame: Week 4, Week 28, Week 44 and Week 52
measure: Summary of Hematology and Clinical Chemistry Parameters Data of Clinical Concern
timeFrame: Up to Week 52
measure: Number of Participants With Laboratory Data of Clinical Concern for Urine Protein
timeFrame: Day 1 to Week 28 and Week 52
measure: Plasma Concentrations of Pazopanib
timeFrame: Week 4, Week 24 and Week 52
Other outcomes:
Locations:
city: Peoria
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: Loma Linda
country: United States
facility: GSK Investigational Site
state: California
city: Poway
country: United States
facility: GSK Investigational Site
state: California
city: Santa Ana
country: United States
facility: GSK Investigational Site
state: California
city: Golden
country: United States
facility: GSK Investigational Site
state: Colorado
city: Fort Myers
country: United States
facility: GSK Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Leawood
country: United States
facility: GSK Investigational Site
state: Kansas
city: Paducah
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Royal Oak
country: United States
facility: GSK Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: GSK Investigational Site
state: Michigan
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Asheville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Ashland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Silverdale
country: United States
facility: GSK Investigational Site
state: Washington
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Aarhus
country: Denmark
facility: GSK Investigational Site
city: Glostrup
country: Denmark
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Udine
country: Italy
facility: GSK Investigational Site
state: Friuli-Venezia-Giulia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Padova
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukushima
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Kagawa
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: