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Sponsored by: |
Bausch & Lomb, Inc. |
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Information provided by: | Bausch & Lomb, Inc. |
ClinicalTrials.gov Identifier: | NCT00468871 |
This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.
Condition | Intervention | Phase |
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Non-Infectious Uveitis |
Drug: fluocinolone acetonide intravitreal implant Drug: systemic corticosteroids and immunocuppressant |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye |
Estimated Enrollment: | 150 |
Study Start Date: | April 2002 |
Study Completion Date: | June 2006 |
Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 415-002 |
Study First Received: | May 2, 2007 |
Last Updated: | May 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00468871 |
Health Authority: | European Union: European Medicines Agency |
Fluocinolone Acetonide Uveitis Eye Diseases |
Anti-Inflammatory Agents Uveal Diseases Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |