A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
NCT ID: NCT00168298
Last Updated: 2019-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
668 participants
INTERVENTIONAL
2004-11-01
2008-09-05
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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700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
350 µg Dexamethasone followed by 700 µg Dexamethasone
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
350 µg Dexamethasone
350 µg Dexamethasone intravitreal implant administered on Day 0.
Sham Injection followed by 700 µg Dexamethasone
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
Sham Injection
Sham injection on Day 0.
Interventions
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700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
350 µg Dexamethasone
350 µg Dexamethasone intravitreal implant administered on Day 0.
Sham Injection
Sham injection on Day 0.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
* Visual acuity in other eye no worse than 20/200
Exclusion Criteria
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Diabetic retinopathy
* Uncontrolled systemic disease
* Known steroid-responder
* Use of systemic steroids
* Use of warfarin/heparin
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Houston, Texas, United States
São Paulo, , Brazil
Mississauga, Ontario, Canada
Bogotá, , Colombia
Kowloon, , Hong Kong
Tamil Nadu, , India
Udine, , Italy
Auckland, , New Zealand
Poznan, , Poland
Singapore, , Singapore
Seoul, , South Korea
Alicante, , Spain
London, , United Kingdom
Countries
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References
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Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.
Other Identifiers
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206207-009
Identifier Type: -
Identifier Source: org_study_id
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