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

Allergan

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Procedure: Laser Photocoagulation; Drug: Sham injection; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00464685

206207-012

Details and patient eligibility

About

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.

Enrollment: 253 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

253 participants in 2 patient groups

700 µg Dexamethasone Implant and Laser Photocoagulation

Experimental group

Description:

Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Treatment:

Procedure: Laser Photocoagulation

Drug: Dexamethasone

Sham Implant and Laser Photocoagulation

Sham Comparator group

Description:

Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Treatment:

Drug: Sham injection

Procedure: Laser Photocoagulation