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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: corticosteroids and immunosuppressants |
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 |
Enrollment: | 140 |
Study Start Date: | April 2002 |
Study Completion Date: | June 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Intravitreal fluocinolone acetonide implant
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Drug: fluocinolone acetonide intravitreal implant
surgical intravitreal implant of fluocinolone acetonide
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2: Active Comparator
Standard of Care
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Drug: corticosteroids and immunosuppressants
Systemic corticosteroids alone or combined with immunosuppressants
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Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bausch & Lomb Incorporated ( Marcia de Souza Lima, MD ) |
Study ID Numbers: | 415-002 |
Study First Received: | May 2, 2007 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00468871 History of Changes |
Health Authority: | European Union: European Medicines Agency |
Anti-Inflammatory Agents Immunologic Factors Fluocinolone Acetonide Uveitis Hormone Antagonists |
Eye Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Immunosuppressive Agents |
Anti-Inflammatory Agents Uveal Diseases Immunologic Factors Fluocinolone Acetonide Eye Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Immunosuppressive Agents Glucocorticoids Hormones Pharmacologic Actions Uveitis Therapeutic Uses |