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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Single Sequence, Open-label Study to Assess the Tolerability, Safety, and Efficacy of 2 Weeks Oral AEB071 300 mg Twice Daily, Followed by 6 Weeks AEB071 200 mg Twice Daily in the Treatment of Patients With Macular Edema Associated With Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis

Conditions
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Uveitis, Posterior Uveitis, Panuveitis

Intervention / Treatment
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* Drug: AEB071


Participation Criteria
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Eligibility Criteria
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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: Serpiginous choroidopathy Acute multifocal placoid pigment epitheliopathy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AEB071<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AEB071 |  | Baseline/Day 1 to Week 8 (Day 56) (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the degree of inflammation in the study eye |  | Baseline/Day 1, Week 8 (Day 56)/end of study | 
| Change in the visual acuity of the study eye |  | Baseline/Day 1, Week 8 (Day 56)/end of study | 
| Change in macular edema in the study eye |  | Baseline/Day 1, Week 8 (Day 56)/end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uveitis, Macular Edema