PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Quark Pharmaceuticals
Study ID
NCT01445899
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • PF-04523655 (Stratum I) — DRUG
    PF-04523655 (a small interfering RNA) - a single IVT injection
  • ranibizumab — DRUG
    6 monthly IVT injections of ranibizumab (Stratum II)
  • PF-04523655 (Stratum II) — DRUG
    6 monthly IVT injections of PF-04523655 (a small interfering RNA)

Study Details

This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patients who participate. Stratum I will determine the maximum tolerated dose and any dose-limiting toxicities. The second part (Stratum II) is a prospectively randomized, multi-center, double-masked, dose ranging study evaluating the efficacy and safety of PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in patients with DME.

Key Dates

First listed
Oct 4, 2011
Start date
Feb 29, 2012
Status verified
Feb 2015
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

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

Arms

  • Experimental: PF-04523655 (Stratum II)
    Stratum II, 6 monthly injections of PF-04523655 only
  • Experimental: PF-04523655 and ranibizumab
    Stratum II, 6 monthly injections of PF-0423655 and ranibizumab administered in combination
  • Active Comparator: ranibizumab
    Stratum II, 6 monthly IVT injections of ranibizumab only
  • Experimental: PF-04523655 (Stratum I)
    Stratum I

Primary Outcome Measure

Safety and dose-limiting toxicities (Stratum I) [ Time Frame: 6 months post-injection ]

Locations (20)

FacilityCityStateZIPSite coordinators
Retina Consultants of ArizonaPhoenixArizona85014-
Retina Institute of CaliforniaArcadiaCalifornia91007-
Retina-Vitreous AssociatesBeverly HillsCalifornia90211-
Retina Diagnostic CenterCampbellCalifornia95008-
Retinal Consultants Medical Group, Inc.SacramentoCalifornia95819-
Orange County Reina Medical GroupSanta AnaCalifornia92705-
MedEye AssociatesMiamiFlorida33143-
Center for Retina and Macular DiseaseWinter HavenFlorida33880-
Southeast Retina CenterAugustaGeorgia30909-
Thomas A. Cuilla, MD, PC at Midwest Eye InstituteIndianapolisIndiana46290-
Eyesight Ophthalmic Services, PAPortsmouthNew Hampshire03801-
Retina Vitreous CenterToms RiverNew Jersey08755-
Southeast Clinical Research Associates, LLCCharlotteNorth Carolina28210-
Black Hills Regioinal Eye InstituteRapid CitySouth Dakota57701-
Tennessee Retina, PCNashvilleTennessee37203-
Retina Research CenterAustinTexas78705-
Retinal Consultants of HoustonHoustonTexas77030-
Valley Retina InstituteMcAllenTexas78503-
Retinal Consultants of San AntonioSan AntonioTexas78204-
Retinal Institute of VirginiaRichmondVirginia23235-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Consultants of Arizona· Phoenix, AZRetina Institute of California· Arcadia, CARetina-Vitreous Associates· Beverly Hills, CARetina Diagnostic Center· Campbell, CARetinal Consultants Medical Group, Inc.· Sacramento, CAOrange County Reina Medical Group· Santa Ana, CA

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