Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
NCT ID: NCT00695318
Last Updated: 2015-05-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
17 participants
INTERVENTIONAL
2008-12-31
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
QUADRUPLE
Study Groups
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A, 2, I 0.2 µg/Day + Sham
0.2 µg/Day
Fluocinolone Acetonide
0.2 µg/Day in study eye + Sham in fellow eye
A, 2, II 0.5 µg/Day + Sham
0.5 µg/Day
Fluocinolone Acetonide
0.5 µg/Day in study eye +Sham in fellow eye
Interventions
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Fluocinolone Acetonide
0.2 µg/Day in study eye + Sham in fellow eye
Fluocinolone Acetonide
0.5 µg/Day in study eye +Sham in fellow eye
Eligibility Criteria
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Inclusion Criteria
* Males and non-pregnant females 55 years old or older
Exclusion Criteria
* History of or current CNV in either eye or the need for anti-angiogenic therapy
* Glaucoma or ocular hypertension (IOP \> 21 mmHg OR concurrent therapy at screening with IOP-lowering agents) in either eye
* Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye
* Any change in systemic steroid therapy within 3 months of screening
* History of vitrectomy in either eye
* Any ocular surgery within 12 weeks of screening in either eye
55 Years
ALL
No
Sponsors
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Alimera Sciences
INDUSTRY
Responsible Party
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Locations
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Kresge Eye Institute
Detroit, Michigan, United States
Countries
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Other Identifiers
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C-01-08-004
Identifier Type: -
Identifier Source: org_study_id
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