Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
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
1 other identifier
interventional
13
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedDecember 22, 2020
February 1, 2017
1.3 years
February 1, 2008
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of AEB071
Baseline/Day 1 to Week 8 (Day 56) (end of study)
Secondary Outcomes (3)
Change in the degree of inflammation in the study eye
Baseline/Day 1, Week 8 (Day 56)/end of study
Change in the visual acuity of the study eye
Baseline/Day 1, Week 8 (Day 56)/end of study
Change in macular edema in the study eye
Baseline/Day 1, Week 8 (Day 56)/end of study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (13)
University of Southern California Doheny Eye Institute
Los Angeles, California, 90033, United States
University of California
San Francisco, California, 94143, United States
Colorado Retina Associates
Denver, Colorado, 80230, United States
University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
University of South Florida, Eye Institute
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
John Hopkins Hospital/Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
MERSI
Cambridge, Massachusetts, 02142, United States
Mayo Clinic Department of Opthalmology
Rochester, Minnesota, 55905, United States
Cornea and Laser Eye Institute
Teaneck, New Jersey, 07666, United States
New York Eye and Ear Infirmary, Clinical Research Department
New York, New York, 10003, United States
Retina Research Centre
Austin, Texas, 78705, United States
Vitreoretinal Consultants
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Novartis investigator site
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2009
Last Updated
December 22, 2020
Record last verified: 2017-02