NCT00846625

Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids Following a Periocular Steroid Injections in Patients on Steroid Sparing Agents or Low Dose Steroids

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a proof of concept study to assess the safety and potential efficacy of ranibizumab in this patient population. Since it is common clinical practice to perform regional periocular injections of steroids in patients with uveitic macular edema, only patients who are refractory to periocular steroids will be enrolled in the study. The 0.5 mg dose of ranibizumab will be given intravitreally since this dose and route has been found to be safe and efficacious in prior studies. A dosing regimen has not been established for ranibizumab in patients with uveitis, so patients will be assessed and treated monthly as needed. Triamcinolone 4mg intravitreal injection will be the steroid treatment, and patients will also be assessed monthly and retreated every three months as needed.

Conditions

• Macular Edema
• Uveitis

Interventions

Type	Name	Description
DRUG	triamcinolone	Intravitreal injection (4 mg/0.1 ml)
DRUG	ranibizumab	Intravitreal injection, 0.5 mg

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2009-02-19
• Last updated: 2014-12-11

Locations

1 site across 1 country: United States