Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
NCT ID: NCT00490815
Last Updated: 2014-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2007-08-31
2011-04-30
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
NONE
Study Groups
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1
Fluocinolone Acetonide
0.5 mg fluocinolone acetonide intravitreal insert
2
Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert
Interventions
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Fluocinolone Acetonide
0.5 mg fluocinolone acetonide intravitreal insert
Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetes mellitus types 1 or 2
* Best corrected visual acuity of ≥ 19 letters
* Retinal thickness \> 250 microns by OCT
* Investigator is comfortable deferring macular laser treatment for 6 weeks
Exclusion Criteria
* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
* Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months
* Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months
* Any ocular surgery within the last 3 months
* Retinal laser treatment within the last 3 months
* History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
* Any lens opacity which impairs visualization of the posterior pole
18 Years
ALL
No
Sponsors
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Alimera Sciences
INDUSTRY
Responsible Party
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Locations
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John Hopkins University
Baltimore, Maryland, United States
Countries
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Other Identifiers
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C-01-06-002
Identifier Type: -
Identifier Source: org_study_id
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