Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
NCT ID: NCT01427751
Last Updated: 2019-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
307 participants
INTERVENTIONAL
2011-10-11
2014-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ozurdex®
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
dexamethasone intravitreal implant
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
Lucentis®
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
ranibizumab
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Interventions
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dexamethasone intravitreal implant
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
ranibizumab
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual acuity between 20/400 to 20/40
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Paris, , France
Munich, , Germany
Tel Aviv, , Israel
Milan, , Italy
Madrid, , Spain
London, , United Kingdom
Countries
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References
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Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.
Other Identifiers
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2010-023900-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MAF-AGN-OPH-RET-004
Identifier Type: -
Identifier Source: org_study_id
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