NCT Number: NCT00615693
Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
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.
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Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
University of Southern California Doheny Eye Institute, Los Angeles, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
- 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
Treatment and study plan
Primary outcomes
-
Safety and tolerability of AEB071
Time frame: Baseline/Day 1 to Week 8 (Day 56) (end of study)
Secondary outcomes
-
Change in the degree of inflammation in the study eye
Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study
-
Change in the visual acuity of the study eye
Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study
-
Change in macular edema in the study eye
Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study
Sponsors and collaborators
Lead sponsor
Novartis
Industry
Registry information
Official study 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
Important dates
- Study start
- 2008
- Primary completion
- 2009
- First posted
- Feb 14, 2008
- Registry last updated
- Dec 22, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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