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

Completed · Phase 2

Conditions studied: Uveitis, Posterior Uveitis, Panuveitis

In brief

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.

Key facts

Study ID

NCT00615693

Run by

Novartis

People needed

13

Starts

2008-07-01

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Emory University — Atlanta, Georgia, 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.