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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615693
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):

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 assessment of efficacy.

Condition or disease Intervention/treatment Phase
Uveitis Posterior Uveitis Panuveitis Drug: AEB071 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: 1 Drug: AEB071

Primary Outcome Measures :
  1. Safety and tolerability of AEB071 [ Time Frame: Baseline/Day 1 to Week 8 (Day 56) (end of study) ]

Secondary Outcome Measures :
  1. Change in the degree of inflammation in the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ]
  2. Change in the visual acuity of the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ]
  3. Change in macular edema in the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    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
  • Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615693

United States, California
University of Southern California Doheny Eye Institute
Los Angeles, California, United States, 90033
University of California
San Francisco, California, United States, 94143
United States, Colorado
Colorado Retina Associates
Denver, Colorado, United States, 80230
United States, Florida
University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
University of South Florida, Eye Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
John Hopkins Hospital/Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Cambridge, Massachusetts, United States, 02142
United States, Minnesota
Mayo Clinic Department of Opthalmology
Rochester, Minnesota, United States, 55905
United States, New Jersey
Cornea and Laser Eye Institute
Teaneck, New Jersey, United States, 07666
United States, New York
New York Eye and Ear Infirmary, Clinical Research Department
New York, New York, United States, 10003
United States, Texas
Retina Research Centre
Austin, Texas, United States, 78705
Vitreoretinal Consultants
Houston, Texas, United States, 77030
Sponsors and Collaborators
Principal Investigator: Novartis Novartis investigator site

Additional Information:
Responsible Party: Novartis Identifier: NCT00615693     History of Changes
Other Study ID Numbers: CAEB071A2211
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Macular Edema

Additional relevant MeSH terms:
Uveitis, Posterior
Uveal Diseases
Eye Diseases