Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

Withdrawn before enrolling · Phase 2

Conditions studied: Macular Edema, Uveitis

In brief

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 facts

Study ID

NCT00846625

Run by

University of Utah

People needed

0

Starts

2009-11-01

Expected to finish

2011-08-01

Last updated by the study team

2014-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• John Moran Eye Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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