Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
This trial is active, not recruiting.
|Conditions||macular edema, retinal vein occlusion|
|Start date||May 2009|
|End date||October 2013|
|Trial size||20 participants|
|Trial identifier||NCT00770770, C-01-08-006|
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
time frame: 3 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) - Central subfield thickness > 300 μm - BCVA of ≥ 24 and ≤ 68 letters - Males and non-pregnant females 18 years and over Exclusion Criteria: - Macular edema secondary to any condition other than RVO - 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
|Official title||A Randomized, Double-masked, Pilot Study of the Safety and Efficacy of 0.5 µg/Day and 0.2 µg/Day Iluvien™ (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg in Subjects With Macular Edema Secondary to Retinal Vein Occlusion|
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