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

Phase 2

Terminated

• Conditions: Non-infectious Uveitis
• Interventions: Drug: Placebo; Drug: Basiliximab

• Registration Number: NCT00646425
• Lead Sponsor: Cerimon Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• Study First Posted: 2008-03-28
• Study Start: 2008-05
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-17
• Last Update Posted: 2010-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Basiliximab	Basiliximab

Primary Outcome Measures

Name	Time	Method
To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications	The primary outcome will be assessed at Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are to assess changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Basiliximab pharmacokinetics and immunogenicity will also be assessed	These measures will be assessed at Week 16

Trial Locations

Locations (6)

Ocular Immunology & Uveitis Foundation; 🇺🇸 Cambridge, Massachusetts, United States

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

Southeast Clinical Research Associates; 🇺🇸 Belmont, North Carolina, United States

Vitreoretinal Consultants; 🇺🇸 Houston, Texas, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States