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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-infectious Uveitis

Intervention / Treatment
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* Drug: Basiliximab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Basiliximab | Drug: Basiliximab<br>* 40 mg basiliximab administered as short iv infusion once every 2 weeks for 3 doses and at Weeks 8 and 12 for a total of 5 doses<br>* Other names: Simulect;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo to match basiliximab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-infectious uveitis