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

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Cerimon Pharmaceuticals
• Collaborator: PPD
• Treatments: Antibodies, Monoclonal; Basiliximab

Criteria

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