Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alimera Sciences
• Treatments: Fluocinolone Acetonide

Criteria

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