Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
ClinicalTrials.gov ID
NCT01427751
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
307Actual
Last Update Posted
Apr 18, 2019Actual
Start Date
Oct 11, 2011Actual
Primary Completion Date
Nov 4, 2014Actual
Completion Date
Nov 4, 2014Actual
Brief 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).
Retinal Vein Occlusion
Macular Edema
dexamethasone intravitreal implant
ranibizumab
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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