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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00615693
First received: February 1, 2008
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Uveitis
Posterior Uveitis
Panuveitis
 Drug: AEB071
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of AEB071 [ Time Frame: Baseline/Day 1 to Week 8 (Day 56) (end of study) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in the degree of inflammation in the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ] [ Designated as safety issue: No ]
  • Change in the visual acuity of the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ] [ Designated as safety issue: No ]
  • Change in macular edema in the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: July 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AEB071

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615693

Locations
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
MERSI
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
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00615693     History of Changes
Other Study ID Numbers: CAEB071A2211
Study First Received: February 1, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Uveitis
Macular Edema

Additional relevant MeSH terms:
Macular Edema
Panuveitis
Uveitis
Chorioretinitis
Uveitis, Intermediate
Uveitis, Posterior
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Retinitis
Choroiditis
Choroid Diseases

ClinicalTrials.gov processed this record on June 18, 2013