Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
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Patients with choroidal neovascularization.
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Patients with the following forms of uveitis:
- Serpiginous choroidopathy
- Acute multifocal placoid pigment epitheliopathy
- White dot retino-choroidopathies (e.g., multiple evanescent white dot syndrome (MEWDS) or multifocal choroiditis)
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Macular edema associated with other ocular disease (e.g., diabetic retinopathy)
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Patients who had a prior vitrectomy
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Any eye condition that may affect the evaluation of visual acuity and retinal thickness
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Concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol)
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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
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Other protocol-defined inclusion/exclusion criteria may apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
13 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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