Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

• Status: Completed
• Trial end date: 2010-02-08
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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

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