Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

Stopped early · Phase 2

Conditions studied: Macular Edema, Retinal Vein Occlusion

In brief

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

Key facts

Study ID

NCT00770770

Run by

Alimera Sciences

People needed

20

Starts

2009-05-01

Last updated by the study team

2015-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kentucky Department of Ophthalmology — Lexington, Kentucky, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Cole Eye Institute — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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