Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)
NCT ID: NCT01396057
Last Updated: 2014-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
244 participants
INTERVENTIONAL
2011-07-31
2013-06-30
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
DOUBLE
Study Groups
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Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split
Dexamethasone
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Dexamethasone Implant
Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.
Sham injection
Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration
Interventions
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Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split
Dexamethasone Implant
Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.
Sham injection
Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of BRVO at maximum 6 months prior to Screening
* BCVA using ETDRS charts of 20/40 to 20/400 in the study eye
Exclusion Criteria
* Central retinal thickness (CRT) \< 250 µm in the study eye
* Prior episode of RVO in the study eye
* Active formation of new vessels in the study eye
* Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
* IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
* Improvement of \> 10 letters on BCVA between Screening and Baseline
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Leipzig, Germany, Germany
Novartis Investigative Site
Regensburg, Germany, Germany
Novartis Investigative Site
Augsburg, , Germany
Novartis Investigative Site
Bad Rothenfelde, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Bremen, , Germany
Novartis Investigative Site
Chemnitz, , Germany
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Cologne, , Germany
Novartis Investigative Site
Darmstadt, , Germany
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Dresden, , Germany
Novartis Investigative Site
Düsseldorf, , Germany
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Düsseldorf, , Germany
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Frankfurt, , Germany
Novartis Investigative Site
Freiburg I. Br, , Germany
Novartis Investigative Site
Glauchau, , Germany
Novartis Investigative Site
Göttingen, , Germany
Novartis Investigative Site
Hagen, , Germany
Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Hamburg, , Germany
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Hamburg, , Germany
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Homburg, , Germany
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Ingolstadt, , Germany
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Karlsruhe, , Germany
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Karlsruhe, , Germany
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Kiel, , Germany
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Ludwigshafen, , Germany
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Marburg, , Germany
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Minden, , Germany
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Munich, , Germany
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Mülheim, , Germany
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München, , Germany
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Münster, , Germany
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Münster, , Germany
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Recklinghausen, , Germany
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Sulzbach, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Wolfsburg, , Germany
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Würzburg, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Bydgoszcz, , Poland
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Bytom, , Poland
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Birmingham, , United Kingdom
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Birmingham, , United Kingdom
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Bradford, , United Kingdom
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Cheshire, , United Kingdom
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Colchester, , United Kingdom
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Derby, , United Kingdom
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Gloucester, , United Kingdom
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Guildford, Surrey, , United Kingdom
Novartis Investigative Site
Kent, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Novartis Investigative Site
Middlesbrough, , United Kingdom
Novartis Investigative Site
Nottingham, , United Kingdom
Novartis Investigative Site
Portsmouth, , United Kingdom
Novartis Investigative Site
Rugby, , United Kingdom
Novartis Investigative Site
Westcliff-on-Sea, , United Kingdom
Novartis Investigative Site
York, , United Kingdom
Countries
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References
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Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD009510. doi: 10.1002/14651858.CD009510.pub3.
Other Identifiers
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2011-001019-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002EDE17
Identifier Type: -
Identifier Source: org_study_id
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