Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema

A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 μg/Day and ASI-001B 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects With Diabetic Macular Edema

This study will evaluate the 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 19-68 letters
• Retinal thickness > 250 micron 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 6 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