Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
NCT ID: NCT01599650
Last Updated: 2016-11-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
455 participants
INTERVENTIONAL
2012-05-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1-ranibizumab monotherapy
Ranibizumab 0.5 mg
Ranibizumab
2-ranibizumab with laser
Ranibizumab 0.5 mg + laser
Ranibizumab
Laser
laser photocoagulation
3-laser monotherapy
Laser monotherapy with Ranibizumab 0.5 mg from Month 6
Laser
laser photocoagulation
Interventions
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Ranibizumab
Laser
laser photocoagulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of visual impairment exclusively due to ME secondary to BRVO
* BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
Exclusion Criteria
* Stroke or myocardial infarction less than 3 months before Screening
* Uncontrolled blood pressure defined as systolic value of \>160 mm Hg or diastolic value of \>100 mm Hg at Screening or Baseline.
* Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
* Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
* Neovascularization of the iris or neovascular glaucoma in the study eye
* Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
* Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
* Focal or grid laser photocoagulation within 4 months before Baseline in the study eye
* Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye
* Any use of intraocular corticosteroid implants (eg, dexamethasone \[Ozurdex®\], fluocinolone acetonide \[Iluvien®\]) in the study eye
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
Parramatta, New South Wales, Australia
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Sydney, New South Wales, Australia
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Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Boisbriand, Quebec, Canada
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Montreal, Quebec, Canada
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Olomouc, , Czechia
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Prague, , Czechia
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Glostrup Municipality, , Denmark
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Dijon, , France
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Lyon, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Pátrai, Greece, Greece
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Thessaloniki, Greece, Greece
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Athens, GR, Greece
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Heraklion Crete, GR, Greece
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Larissa, GR, Greece
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Thessaloniki, GR, Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Dublin, Ireland, Ireland
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Dublin, , Ireland
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Bologna, BO, Italy
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Florence, FI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Torino, TO, Italy
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Bari, , Italy
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Udine, , Italy
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Leiden 2333 ZA, Netherlands, Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Bielsko-Biala, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Porto, Porto District, Portugal
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Coimbra, Portugal, Portugal
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Coimbra, Portugal, Portugal
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Porto, Portugal, Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Žilina, Slovak Republic, Slovakia
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Bratislava, Slovakia, Slovakia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bilbao, Basque Country, Spain
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Valladolid, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Santiago de Compostela, Galicia, Spain
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Madrid, Madrid, Spain
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Alicante, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Örebro, , Sweden
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Olten, Switzerland, Switzerland
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Zurich, Switzerland, Switzerland
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Bern, , Switzerland
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Lausanne, , Switzerland
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Frimley, Surrey, United Kingdom
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London, United Kingdom, United Kingdom
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Belfast, , United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Plymouth, , United Kingdom
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Southampton, , United Kingdom
Countries
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References
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Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.
Tadayoni R, Waldstein SM, Boscia F, Gerding H, Gekkieva M, Barnes E, Das Gupta A, Wenzel A, Pearce I; BRIGHTER Study Group. Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study. Ophthalmology. 2017 Dec;124(12):1778-1787. doi: 10.1016/j.ophtha.2017.06.027. Epub 2017 Aug 12.
Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S, Wenzel A, Barnes E, Gekkieva M, Pilz S, Mones J; BRIGHTER study group. Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER. Ophthalmology. 2016 Jun;123(6):1332-44. doi: 10.1016/j.ophtha.2016.02.030. Epub 2016 Mar 30.
Other Identifiers
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2011-002859-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002E2402
Identifier Type: -
Identifier Source: org_study_id