Status:
COMPLETED
Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Lead Sponsor:
Allergan
Conditions:
Retinal Vein Occlusion
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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).
Eligibility Criteria
Inclusion
- Diagnosis of branch retinal vein occlusion in at least one eye
- Visual acuity between 20/400 to 20/40
Exclusion
- 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
Key Trial Info
Start Date :
October 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2014
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT01427751
Start Date
October 11 2011
End Date
November 4 2014
Last Update
April 18 2019
Active Locations (6)
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1
Paris, France
2
Munich, Germany
3
Tel Aviv, Israel
4
Milan, Italy