Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina (FAVOR)
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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
Study Start Date
Primary Completion Date
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To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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