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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646425

Acronym

BSX-003

Enrollment

Registered

2008-03-28

Start date

2008-05-31

Completion date

2008-11-30

Last updated

2010-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-infectious Uveitis

Keywords

Non-infectious uveitis

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.

Interventions

DRUGBasiliximab

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

DRUGPlacebo

Placebo to match basiliximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026