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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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 next 12 months;

• 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