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

Part of paid clinical trials in Peoria, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT01134055
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pazopanib eye drops — DRUG
    A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
  • placebo — DRUG
    placebo eye drops
  • ranibizumab intravitreal injection — BIOLOGICAL
    Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A

Study Details

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.

Key Dates

First listed
May 31, 2010
Start date
Jun 1, 2010
Status verified
Dec 2017
Primary completion
Oct 1, 2012
Completion
Oct 1, 2012

Study Design

Enrollment
510 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome 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 [ Time Frame: Day 1 and 52 weeks ]

Locations (37)

FacilityCityStateZIPSite coordinators
GSK Investigational SitePeoriaArizona85381-
GSK Investigational SitePhoenixArizona85014-
GSK Investigational SitePhoenixArizona85020-
GSK Investigational SiteTucsonArizona85704-
GSK Investigational SiteTucsonArizona85710-
GSK Investigational SiteIrvineCalifornia92697-
GSK Investigational SiteLoma LindaCalifornia92354-
GSK Investigational SitePowayCalifornia92064-
GSK Investigational SiteSanta AnaCalifornia92705-
GSK Investigational SiteGoldenColorado80401-
GSK Investigational SiteFort MyersFlorida33901-
GSK Investigational SiteWinter HavenFlorida33880-
GSK Investigational SiteChicagoIllinois60612-
GSK Investigational SiteLeawoodKansas66211-
GSK Investigational SitePaducahKentucky42001-
GSK Investigational SiteBaltimoreMaryland21287-
GSK Investigational SiteBostonMassachusetts02114-
GSK Investigational SiteRoyal OakMichigan48073-
GSK Investigational SiteTraverse CityMichigan49686-
GSK Investigational SiteNew YorkNew York10003-
GSK Investigational SiteAshevilleNorth Carolina28803-
GSK Investigational SiteChapel HillNorth Carolina27599-
GSK Investigational SiteCharlotteNorth Carolina28210-
GSK Investigational SiteBeachwoodOhio44122-
GSK Investigational SiteClevelandOhio44130-
GSK Investigational SiteClevelandOhio44195-
GSK Investigational SiteColumbusOhio43212-
GSK Investigational SiteAshlandOregon97520-
GSK Investigational SitePortlandOregon97239-
GSK Investigational SitePhiladelphiaPennsylvania19107-
GSK Investigational SiteAustinTexas78705-
GSK Investigational SiteDallasTexas75231-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteSalt Lake CityUtah84107-
GSK Investigational SiteSeattleWashington98104-
GSK Investigational SiteSilverdaleWashington98383-
GSK Investigational SiteMadisonWisconsin53705-

Find similar trials in Peoria, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
GSK Investigational Site· Peoria, AZGSK Investigational Site· Phoenix, AZGSK Investigational Site· Tucson, AZGSK Investigational Site· Irvine, CAGSK Investigational Site· Loma Linda, CAGSK Investigational Site· Poway, CA

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