Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

• 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

• History of vitrectomy

• Central retinal thickness ≥ 275 µm

• Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion Criteria:

• Known anticipated need for ocular surgery during the study period

• History of glaucoma or current high eye pressure requiring more than 1 medication

• Uncontrolled systemic disease

• Known allergy to the study medication

• Known steroid-responder

• Use of systemic steroids

• Female subjects that are pregnant, nursing or planning a pregnancy