Conditions: Macular Edema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 262
Healthy volunteers: no

Brief summary:
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.

Detailed description:

Arms:
arm 1: 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. arm 2: Sham administered in the study eye on Day 1.

Interventions: intervention 1: 700 μg Dexamethasone intervention 2: Sham
Intervention descriptions: intervention 1: 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. intervention 2: Sham administered in the study eye on Day 1.

Protocol document: