Conditions: Diabetic Macular Edema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 253
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Dexamethasone intervention 2: Sham injection intervention 3: Laser Photocoagulation
Intervention descriptions: intervention 1: Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. intervention 2: Initial sham injection with up to 1 additional treatment based on re-treatment criteria. intervention 3: Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Protocol document: