Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

• Status: Withdrawn
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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