Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

• Status: Completed
• Trial end date: 2014-05-20
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

Exclusion Criteria:

• History of glaucoma, ocular hypertension or optic nerve head change

• Any active bacterial, viral, parasitic, or fungal infections in either eye

• Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start

• History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start

• Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start

• Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start

• Use of topical ophthalmic corticosticosteroids within 2 weeks of study start