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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00615693 |
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 | Intervention | Phase |
---|---|---|
Uveitis Posterior Uveitis Panuveitis |
Drug: AEB071 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 15 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: AEB071 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with the following forms of uveitis:
Contact: Novartis | 862 778 8300 |
United States, California | |
Novartis Investigator Site | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Novartis 862-778-8300 | |
Novartis Investigator Site | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Novartis 862-778-8300 | |
United States, Colorado | |
Novartis Investigator Site | Recruiting |
Denver, Colorado, United States, 80230 | |
Contact: Joondeph 303-261-1600 Brian.Joondeph@retinalalliance.com | |
Novartis Investigator Site | Recruiting |
Denver, Colorado, United States, 80210 | |
Contact: Giambartolomei 303-765-3536 | |
United States, Florida | |
Novartis Investigator Site | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: NOVARTIS 862-778-8300 | |
Novartis Investigator Site | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Leto 813-974-1553 | |
United States, Georgia | |
Novartis Investigator Site | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: NOVARTIS 862-778-8300 | |
United States, Minnesota | |
Novartis Investigator Site | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Nielsen 507-284-5833 | |
United States, Texas | |
Novartis Investigator Site | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Mutz 713-524-3434 info@houstonretina.com | |
Novartis Investigator Site | Recruiting |
Austin, Texas, United States, 78705 | |
Contact: Novartis 862-778-8300 |
Principal Investigator: | Novartis | Novartis investigator site |
Responsible Party: | Novartis ( Novartis ) |
Study ID Numbers: | CAEB071A2211 |
Study First Received: | February 1, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00615693 |
Health Authority: | United States: Food and Drug Administration |
Uveitis Macular Edema |
Panuveitis Macular Edema Uveitis, Intermediate Uveitis, Posterior |
Uveitis Eye Diseases Edema |
Uveal Diseases |