Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
This trial is active, not recruiting.
|Condition||age-related macular degeneration|
|Treatments||fluocinolone acetonide, sham injection|
|Start date||December 2008|
|End date||December 2014|
|Trial size||40 participants|
|Trial identifier||NCT00695318, C-01-08-004|
This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change from baseline in size of geographic atrophy
time frame: 24 months
Male or female participants at least 55 years old.
Inclusion Criteria: - Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas - Males and non-pregnant females 55 years old or older Exclusion Criteria: - GA secondary to any condition other than AMD in either eye - 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
|Official title||A Randomized, Double-Masked, Fellow-Eye Comparison Of The Safety And Efficacy Of 0.2 And 0.5 µg/Day Fluocinolone Acetonide Intravitreal Insert To Sham Injection In Subjects With Bilateral Geographic Atrophy Due To AMD|
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