Status:
COMPLETED
Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Lead Sponsor:
Novartis
Conditions:
Uveitis
Posterior Uveitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00615693
Start Date
July 1 2008
Last Update
December 22 2020
Active Locations (13)
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1
University of Southern California Doheny Eye Institute
Los Angeles, California, United States, 90033
2
University of California
San Francisco, California, United States, 94143
3
Colorado Retina Associates
Denver, Colorado, United States, 80230
4
University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
Miami, Florida, United States, 33136