Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT00846625
Phase
PHASE2
Status
Withdrawn

Conditions

  • Macular Edema
  • Uveitis

Eligibility Criteria

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

Interventions

  • triamcinolone — DRUG
    Intravitreal injection (4 mg/0.1 ml)
  • ranibizumab — DRUG
    Intravitreal injection, 0.5 mg

Study Details

This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-infectious uveitis. There is currently no FDA-approved therapy for this condition, however intravitreal injection of corticosteroids, in conjunction with oral steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. Ranibizumab is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active forms of vascular endothelial growth factor (VEGF), which is believed to contribute to the etiology of inflammation and neovascularization. Ranibizumab is FDA-approved for the treatment of neovascular age-related macular degeneration.

Key Dates

First listed
Feb 19, 2009
Start date
Nov 30, 2009
Status verified
Dec 2014
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

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

Arms

  • Experimental: 1
    Ranibizumab (0.5 mg)
  • Active Comparator: 2
    Triamcinolone (4 mg/0.1 ml)

Primary Outcome Measure

Ocular adverse events [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
John Moran Eye CenterSalt Lake CityUtah84132-

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John Moran Eye Center· Salt Lake City, UT

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