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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00615693

Collaborator

(none)

Enrollment

Locations

Arm

Patient Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis Posterior Uveitis Panuveitis	Drug: AEB071	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AEB071

Arm

Intervention/Treatment

Experimental: 1

Drug: AEB071

Outcome Measures

Primary Outcome Measures

Safety and tolerability of AEB071 [Baseline/Day 1 to Week 8 (Day 56) (end of study)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California Doheny Eye Institute	Los Angeles	California	United States	90033
2	University of California	San Francisco	California	United States	94143
3	Colorado Retina Associates	Denver	Colorado	United States	80230
4	University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute	Miami	Florida	United States	33136
5	University of South Florida, Eye Institute	Tampa	Florida	United States	33612
6	Emory University	Atlanta	Georgia	United States	30322
7	John Hopkins Hospital/Wilmer Eye Institute	Baltimore	Maryland	United States	21287
8	MERSI	Cambridge	Massachusetts	United States	02142
9	Mayo Clinic Department of Opthalmology	Rochester	Minnesota	United States	55905
10	Cornea and Laser Eye Institute	Teaneck	New Jersey	United States	07666
11	New York Eye and Ear Infirmary, Clinical Research Department	New York	New York	United States	10003
12	Retina Research Centre	Austin	Texas	United States	78705
13	Vitreoretinal Consultants	Houston	Texas	United States	77030