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Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
This study is currently recruiting participants.
Verified by Novartis, November 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00615693
  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 II

MedlinePlus related topics: Edema
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To assess the safety and tolerability of AEB071 in the treatment of uveitis

Secondary Outcome Measures:
  • To investigate how many uveitis patients will have a reduction in uveitis in response to AEB071

Estimated Enrollment: 15
Study Start Date: July 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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 that was determined to have been present for less than 12 months
  • 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

Contacts
Contact: Novartis 862 778 8300

Locations
United States, California
Novartis Investigator Site Recruiting
San Francisco, California, United States, 94143
Contact: Novartis     862-778-8300        
Novartis Investigator Site Recruiting
Los Angeles, California, United States, 90033
Contact: Novartis     862-778-8300        
United States, Colorado
Novartis Investigator Site Recruiting
Denver, Colorado, United States, 80230
Contact: Joondeph     303-261-1600     Brian.Joondeph@retinalalliance.com    
Novartis Investigator Site Recruiting
Denver, Colorado, United States, 80210
Contact: Giambartolomei     303-765-3536        
United States, Florida
Novartis Investigator Site Recruiting
Miami, Florida, United States, 33136
Contact: NOVARTIS     862-778-8300        
Novartis Investigator Site Recruiting
Tampa, Florida, United States, 33612
Contact: Leto     813-974-1553        
United States, Georgia
Novartis Investigator Site Recruiting
Atlanta, Georgia, United States, 30322
Contact: NOVARTIS     862-778-8300        
United States, Minnesota
Novartis Investigator Site Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nielsen     507-284-5833        
United States, Texas
Novartis Investigator Site Recruiting
Houston, Texas, United States, 77030
Contact: Mutz     713-524-3434     info@houstonretina.com    
Novartis Investigator Site Recruiting
Austin, Texas, United States, 78705
Contact: Novartis     862-778-8300        
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

Responsible Party: Novartis ( Novartis )
Study ID Numbers: CAEB071A2211
Study First Received: February 1, 2008
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00615693  
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Uveitis
Macular Edema

Study placed in the following topic categories:
Panuveitis
Macular Edema
Uveitis, Intermediate
Uveitis, Posterior
Uveitis
Eye Diseases
Edema

Additional relevant MeSH terms:
Uveal Diseases

ClinicalTrials.gov processed this record on January 14, 2009