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

Uveitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615693
• Other study ID #: CAEB071A2211
• Status: Completed
• Phase: Phase 2
• Start date: July 2008

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Panuveitis
• Posterior Uveitis
• Uveitis
• Uveitis, Posterior

Intervention

Drug:
• AEB071

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Retina Research Centre	Austin	Texas
United States	John Hopkins Hospital/Wilmer Eye Institute	Baltimore	Maryland
United States	MERSI	Cambridge	Massachusetts
United States	Colorado Retina Associates	Denver	Colorado
United States	Vitreoretinal Consultants	Houston	Texas
United States	University of Southern California Doheny Eye Institute	Los Angeles	California
United States	University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute	Miami	Florida
United States	New York Eye and Ear Infirmary, Clinical Research Department	New York	New York
United States	Mayo Clinic Department of Opthalmology	Rochester	Minnesota
United States	University of California	San Francisco	California
United States	University of South Florida, Eye Institute	Tampa	Florida
United States	Cornea and Laser Eye Institute	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of AEB071		Baseline/Day 1 to Week 8 (Day 56) (end of study)
Secondary	Change in the degree of inflammation in the study eye		Baseline/Day 1, Week 8 (Day 56)/end of study
Secondary	Change in the visual acuity of the study eye		Baseline/Day 1, Week 8 (Day 56)/end of study
Secondary	Change in macular edema in the study eye		Baseline/Day 1, Week 8 (Day 56)/end of study

External Links

•   Results for CAEB071A2211 from the Novartis Clinical Trials website.