A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis
NCT ID: NCT00333814
Last Updated: 2011-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
229 participants
INTERVENTIONAL
2006-05-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Dexamethasone 350 µg
Dexamethasone
Dexamethasone 350 µg; injection drug delivery system at Day 0
2
Dexamethasone 700 µg
dexamethasone
Dexamethasone 700 µg injection drug delivery system at Day 0
3
Sham
Sham injection
Sham injection at Day 0
Interventions
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Dexamethasone
Dexamethasone 350 µg; injection drug delivery system at Day 0
dexamethasone
Dexamethasone 700 µg injection drug delivery system at Day 0
Sham injection
Sham injection at Day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any active ocular infections
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Allergan, Inc.
Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Dallas, Texas, United States
Sydney, , Australia
Vienna, , Austria
São Paulo, São Paulo/SP, Brazil
Montreal, Quebec, Canada
Prague, , Czechia
Paris, , France
Heidelberg, , Germany
Cholargós, , Greece
Hyderabad, , India
Petah Tikva, , Israel
Gdansk, , Poland
Coimbra, , Portugal
Johannesburg, , South Africa
Seoul, , South Korea
Madrid, , Spain
Lausanne, , Switzerland
London, , United Kingdom
Countries
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References
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Lightman S, Belfort R Jr, Naik RK, Lowder C, Foster CS, Rentz AM, Cui H, Whitcup SM, Kowalski JW, Revicki DA. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. 2013 Jul 18;54(7):4864-70. doi: 10.1167/iovs.12-10981.
Naik RK, Rentz AM, Foster CS, Lightman S, Belfort R Jr, Lowder C, Whitcup SM, Kowalski JW, Revicki DA. Normative comparison of patient-reported outcomes in patients with noninfectious uveitis. JAMA Ophthalmol. 2013 Feb;131(2):219-25. doi: 10.1001/2013.jamaophthalmol.102.
Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
Related Links
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Other Identifiers
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206207-014
Identifier Type: -
Identifier Source: org_study_id
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