Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema

This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema

Inclusion Criteria:

• Age >= 18 years with diabetic macular edema
• Diagnosis of diabetes mellitus types 1 or 2
• Best corrected visual acuity of ≥ 19 letters
• Retinal thickness > 250 microns by OCT
• Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

• Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents
• Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
• Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months
• Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months
• Any ocular surgery within the last 3 months
• Retinal laser treatment within the last 3 months
• History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
• Any lens opacity which impairs visualization of the posterior pole