Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
NCT ID: NCT00770770
Last Updated: 2015-05-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2009-05-31
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
DOUBLE
Study Groups
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Fluocinolone Acetonide 0.2 µg/day
0.2 µg/day
Fluocinolone Acetonide
0.2 µg/day
Fluocinolone Acetonide 0.5 µg/day
0.5 µg/day
Fluocinolone Acetonide
0.5 µg/day
Interventions
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Fluocinolone Acetonide
0.2 µg/day
Fluocinolone Acetonide
0.5 µg/day
Eligibility Criteria
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Inclusion Criteria
* Central subfield thickness \> 300 μm
* BCVA of ≥ 24 and ≤ 68 letters
* Males and non-pregnant females 18 years and over
Exclusion Criteria
* Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye
* Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss
* Glaucoma or ocular hypertension (IOP \> 21 mmHg or concurrent therapy at screening with IOP-lowering agents)
* Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye
* Any change in systemic steroid therapy within 3 months of screening
* History of vitrectomy in the study eye
18 Years
ALL
No
Sponsors
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Alimera Sciences
INDUSTRY
Responsible Party
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Locations
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University of Kentucky Department of Ophthalmology
Lexington, Kentucky, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Cole Eye Institute
Cleveland, Ohio, United States
Countries
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Other Identifiers
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C-01-08-006
Identifier Type: -
Identifier Source: org_study_id
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