The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis

Randomized, Double-Masked, Placebo-controlled Evaluation of the Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis Who Undergo Tapering of Concomitant Immunosuppressive Medications

The objective of this trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their uveitis.

Inclusion Criteria:

• Diagnosis of noninfectious intermediate, posterior or panuveitis of at least 3 months duration
• Treatment with greater than or equal to 20 mg/day of Prednisone at baseline or immunosuppressive drug score of greater than or equal to 5 at baseline
• BCVA by ETDRS protocol better than or equal to 20/200
• Intraocular pressure of 24 mmHg or less
• Anterior chamber cells and vitreous haze of less than or equal to 1
• Male or females, aged 12 or greater, body weight of 40 kg or greater

Exclusion Criteria:

• Prior treatment with Retisert
• Primary diagnosis of anterior uveitis, uveitis of infectious etiology or Behcet's disease
• Pregnancy or breast-feeding
• Increase in systemic immunosuppressive treatment regimen within 6 weeks before baseline