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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-11-30

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.

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Detailed Description

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Conditions

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Non-infectious Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Basiliximab

Group Type EXPERIMENTAL

Basiliximab

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match basiliximab

Interventions

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Basiliximab

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

Intervention Type DRUG

Placebo

Placebo to match basiliximab

Intervention Type DRUG

Other Intervention Names

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Simulect

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No