Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids
| Status: | Archived |
|---|---|
| Conditions: | Cervical Cancer, Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2009 |
| End Date: | December 2011 |
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
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.
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.
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