A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

Key Inclusion Criteria:

• 18 years of age or older with diabetic macular edema;
• Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
• Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

• Known anticipated need for ocular surgery within first 12 months of study;
• History of glaucoma or current high eye pressure requiring more than 1 medication;
• Uncontrolled systemic disease;
• Known steroid-responder;
• Use of systemic steroids
• Use of Warfarin/Heparin