Status:
TERMINATED
The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis
Lead Sponsor:
Cerimon Pharmaceuticals
Collaborating Sponsors:
PPD Development, LP
Conditions:
Non-infectious Uveitis
Eligibility:
All Genders
12-80 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00646425
Start Date
May 1 2008
End Date
November 1 2008
Last Update
August 19 2010
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Ocular Immunology & Uveitis Foundation
Cambridge, Massachusetts, United States, 02142
2
Tauber Eye Center
Kansas City, Missouri, United States, 64111
3
New York Eye and Ear Infirmary
New York, New York, United States, 10003
4
Southeast Clinical Research Associates
Belmont, North Carolina, United States, 28012