Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

Inclusion Criteria:

• Male and female patients with non-infectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health

• Macular edema with average central retinal thickness ≥ 250 µm

• A vitreous haze score ≥ 1, but ≤ 3 (based on the National Eye Institute grading system)

• Best Corrected Visual Acuity no worse than 20/400 and no better than 20/40

• Daily prednisone dose < 1 mg/kg

Exclusion Criteria:

• Patients with choroidal neovascularization.

• Patients with the following forms of uveitis:

1. Serpiginous choroidopathy

2. Acute multifocal placoid pigment epitheliopathy

3. White dot retino-choroidopathies (e.g., multiple evanescent white dot syndrome (MEWDS) or multifocal choroiditis)

• Macular edema associated with other ocular disease (e.g., diabetic retinopathy)

• Patients who had a prior vitrectomy

• Any eye condition that may affect the evaluation of visual acuity and retinal thickness

• Concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol)

• Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g. deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months

• Other protocol-defined inclusion/exclusion criteria may apply