WithdrawnPhase 2

Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

Stopped: Insufficient enrollment (no subjects were enrolled)

United States0Started 2009-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least 18 years of age * History of non-infectious uveitis w chronic cystoid macular edema * Refractory to therapy w periocular steroids; Last periocular steroid injection a minimum of 3 months prior to study enrollment * Currently using oral steroids (\< or = 10 mg/day) and/or steroid sparing agents * BCVA between 20/40 and 20/400 * IOP between 5 mmHg and 30 mmHg * Media clarity sufficient for OCT measurement Exclusion Criteria: * Women known to be pregnant or have a positive urine pregnancy test; Pre-menopausal women not using adequate contraception during the study * Prior treatment for CME with Macugen or Avastin in the study eye * History of stroke * Presence of vitreous hemorrhage or epiretinal membrane in the study eye * Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye * Presence or history of uncontrolled glaucoma * Known allergy or hypersensitivity to any component of the study drug * Major surgery planned during the next 6 months * Simultaneous participation in another clinical investigation

What they're measuring

Ocular adverse events

Timeframe: 12 months

Trial details

NCT IDNCT00846625

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08