Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion

• Status: Completed
• Trial end date: 2014-11-04
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of branch retinal vein occlusion in at least one eye

• Visual acuity between 20/400 to 20/40

Exclusion Criteria:

• Active eye infection

• Ocular hypertension which is not controlled on monotherapy (one medication)

• Anticipated need for eye surgery during the study

• Cataract surgery in either eye within 3 months

• Eye surgery including laser of any type within 6 months

• Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months

• Use of ocular steroids within 3 months

• Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study