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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEB071 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AEB071 | Baseline/Day 1 to Week 8 (Day 56) (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
Patients with choroidal neovascularization.
Patients with the following forms of uveitis:
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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California Doheny Eye Institute | Los Angeles | California | 90033 | United States | ||
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| Label | URL |
|---|---|
| Results for CAEB071A2211 from the Novartis Clinical Trials website. | View source |
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| Change in macular edema in the study eye |
| Baseline/Day 1, Week 8 (Day 56)/end of study |
| 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 |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D015866 | Uveitis, Posterior |
| D015864 | Panuveitis |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
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