Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
NCT ID: NCT01780935
Last Updated: 2017-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
671 participants
INTERVENTIONAL
2013-06-03
2015-07-09
Brief Summary
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The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.
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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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RBZ 0.5 mg: VA only (Group I)
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
Ranibizumab
Intravitreal injections of 0.5 mg Ranibizumab
RBZ 0.5 mg: VA and/or OCT (Group II)
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
Ranibizumab
Intravitreal injections of 0.5 mg Ranibizumab
Interventions
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Ranibizumab
Intravitreal injections of 0.5 mg Ranibizumab
Eligibility Criteria
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Inclusion Criteria
* Active, newly diagnosed, untreated CNV due to AMD
* CNV involving the center of the retina
* A qualifying vision score at study entry
Exclusion Criteria
* Active injection or inflammation of either eye at the time of study entry
50 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
Buenos Aires, , Argentina
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Ciudad Autonoma de Bs As, , Argentina
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Vienna, , Austria
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Boisbriand, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Medellín, Antioquia, Colombia
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Bogotá, Cundinamarca, Colombia
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Olomouc, CZE, Czechia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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HUS, , Finland
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Kuopio, , Finland
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Paris, , France
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Bonn, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Darmstadt, , Germany
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Freiburg im Breisgau, , Germany
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München, , Germany
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Münster, , Germany
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Münster, , Germany
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Regensburg, , Germany
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Ampelokipoi, Athens, Greece
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Glyfada, Athens, Greece
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Athens, GR, Greece
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Ioannina, , Greece
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Guatemala City, , Guatemala
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Guatemala City, , Guatemala
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Veszprém, , Hungary
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Zalaegerszeg, , Hungary
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Dublin, , Ireland
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Waterford, , Ireland
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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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Udine, UD, Italy
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Kaunas, LTU, Lithuania
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Vilnius, , Lithuania
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Mexico City, Mexico City, Mexico
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's-Hertogenbosch, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Panama City, , Panama
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Nitra, , Slovakia
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Trenčín, , Slovakia
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Zvolen, , Slovakia
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Žilina, , Slovakia
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Bilbao, Basque Country, Spain
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Santiago de Compostela, Galicia, Spain
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Oviedo, Principality of Asturias, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Linköping, , Sweden
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Bern, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Frimley, Surrey, United Kingdom
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Belfast, , United Kingdom
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Bristol, , United Kingdom
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Cheshire, , United Kingdom
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Derby, , United Kingdom
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Gloucester, , United Kingdom
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Great Yarmouth, , United Kingdom
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Guildford, Surrey, , United Kingdom
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Hull, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Middlesbrough, , United Kingdom
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Rugby, , United Kingdom
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Southampton, , United Kingdom
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Wolverhampton, , United Kingdom
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York, , United Kingdom
Countries
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References
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Staurenghi G, Garweg JG, Gerendas BS, Macfadden W, Gekkiev B, Margaron P, Dunger-Baldauf C, Kolar P. Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study. BMC Ophthalmol. 2020 Jan 9;20(1):18. doi: 10.1186/s12886-019-1251-6.
Other Identifiers
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2011-004959-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002A2405
Identifier Type: -
Identifier Source: org_study_id
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