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

Allergan

Status and phase: Completed; Phase 3

Conditions: Macular Edema

Treatments: Procedure: Laser Photocoagulation; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02121262

206207-026

Details and patient eligibility

About

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

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

284 participants in 2 patient groups

Laser Photocoagulation

Other group

Description:

Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.

Treatment:

Procedure: Laser Photocoagulation

Dexamethasone

Experimental group

Description:

Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.

Treatment:

Drug: Dexamethasone