Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

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

This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.

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