A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).

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

Details

• Lead Sponsor: Allergan
• Collaborator: Tigermed Consulting Co., Ltd
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Diagnosis of diabetes mellitus (type 1 or type 2)

• Presence of macular edema

Exclusion Criteria:

• Anticipated need for ocular surgery in the study eye during the study

• Laser photocoagulation in the study eye within 3 months

• Cataract surgery within 3 months