Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01134055
First received: May 27, 2010
Last updated: July 11, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Drug: pazopanib eye drops
Drug: placebo
Biological: ranibizumab intravitreal injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in best-corrected visual acuity [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of ranibizumab intravitreal injections [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 503
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: investigational arm 1
5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
Experimental: investigational arm 2
5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
Experimental: investigational arm 3
10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
Experimental: investigational arm 4
10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
Experimental: investigational arm 5
10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
Placebo Comparator: placebo control arm
Placebo eye drops QID with allowance for as-needed ranibizumab injection
Drug: placebo
placebo eye drops
Active Comparator: active open-label control arm
Ranibizumab intravitreal injection every 4 weeks
Biological: ranibizumab intravitreal injection
Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A

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 IVT injection if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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-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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134055

Locations
Japan
GSK Investigational Site
Aichi, Japan, 462-0825
GSK Investigational Site
Aichi, Japan, 460-0011
GSK Investigational Site
Aichi, Japan, 466-8560
GSK Investigational Site
Chiba, Japan, 279-0021
GSK Investigational Site
Hokkaido, Japan, 001-0016
GSK Investigational Site
Hokkaido, Japan, 060-8604
GSK Investigational Site
Kagawa, Japan, 761-0793
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01134055     History of Changes
Other Study ID Numbers: 110852
Study First Received: May 27, 2010
Last Updated: July 11, 2013
Health Authority: ITALY: Dr. BRUNO CRAVEDI, Direttore Generale dell'Azienda USL 4, Viale della Repubblica, 240, 59100 Prato
Belgium: Federal Agency for Medicinal Products and Health Products
Australia: Human Research Ethics Committee
Canada: Health Canada
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Denmark: Danish Medicines Agency
United States: Food and Drug Administration
Japan: MHLW (Ministry of Health, Labour and Welfare)
Sweden: Läkemedelsverket

Keywords provided by GlaxoSmithKline:
ranibizumab
wet AMD
MD7110852
age related macular degeneration
age-related macular degeneration
macular degeneration
pazopanib

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014