Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
NCT ID: NCT00615693
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
AEB071
Interventions
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AEB071
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: PRINCIPAL_INVESTIGATOR
Novartis investigator site
Locations
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Emory University
Atlanta, Georgia, United States
University of Southern California Doheny Eye Institute
Los Angeles, California, United States
University of California
San Francisco, California, United States
Colorado Retina Associates
Denver, Colorado, United States
University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
Miami, Florida, United States
University of South Florida, Eye Institute
Tampa, Florida, United States
John Hopkins Hospital/Wilmer Eye Institute
Baltimore, Maryland, United States
MERSI
Cambridge, Massachusetts, United States
Mayo Clinic Department of Opthalmology
Rochester, Minnesota, United States
Cornea and Laser Eye Institute
Teaneck, New Jersey, United States
New York Eye and Ear Infirmary, Clinical Research Department
New York, New York, United States
Retina Research Centre
Austin, Texas, United States
Vitreoretinal Consultants
Houston, Texas, United States
Countries
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Related Links
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Results for CAEB071A2211 from the Novartis Clinical Trials website.
Other Identifiers
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CAEB071A2211
Identifier Type: -
Identifier Source: org_study_id