Phase II Open Label Multicenter Study For Age Related Macular Degeneration Comparing PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV (MONET Study).

Part of paid clinical trials in San Francisco, California.

Sponsor
Quark Pharmaceuticals
Study ID
NCT00713518
Phase
PHASE2
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

Study Details

The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose.

Key Dates

First listed
Jul 11, 2008
Start date
Nov 30, 2009
Status verified
Oct 2012
Primary completion
Nov 30, 2010
Completion
Jul 31, 2011

Study Design

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

Arms

  • Active Comparator: Arm 1 ranibizumab
    0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12
  • Experimental: Arm 2 ranibizumab and PF-04523655
    0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg PF-04523655 given by intravitreal injection every 2 weeks from Week 4 to Week 12
  • Experimental: Arm 3 ranibizumab and PF-04523655
    0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg PF-04523655 given by intravitreal injection evey 4 weeks to Week 12
  • Experimental: Arm 4 ranibizumab and PF-04523655
    0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg of PF-04523655 given by intravitreal injection every 4 weeks from Week 4 to Week 12
  • Experimental: Arm 5 ranibizumab and PF-04523655
    0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg of PF-04523655 (30 minutes later) given in combination every 4 weeks from baseline to Week 12

Primary Outcome Measure

Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16 [ Time Frame: Week 16 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Pfizer Investigational SiteSan FranciscoCalifornia94143-
Pfizer Investigational SiteFort MyersFlorida33912-
Pfizer Investigational SiteWinter HavenFlorida33880-
Pfizer Investigational SiteAugustaGeorgia30909-
Pfizer Investigational SiteIndianapolisIndiana46290-
Pfizer Investigational SiteClevelandOhio44195-
Pfizer Investigational SiteAustinTexas78705-

Find similar trials in San Francisco, CA

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Pfizer Investigational Site· San Francisco, CAPfizer Investigational Site· Fort Myers, FLPfizer Investigational Site· Winter Haven, FLPfizer Investigational Site· Augusta, GAPfizer Investigational Site· Indianapolis, INPfizer Investigational Site· Cleveland, OH

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