Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.
NCT ID: NCT02581995
Last Updated: 2018-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
560 participants
INTERVENTIONAL
2015-11-19
2017-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1 / Quality of Life
Aflibercept treatment in subjects with diabetic macular edema (DME)
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection
Interventions
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Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
* Decrease in vision determined to be primarily the result of DME in the study eye
* BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Graz, Styria, Austria
Vienna, , Austria
Vienna, , Austria
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Hradec Králové, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Créteil, , France
Marseille, , France
Darmstadt, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Marburg, Hesse, Germany
Göttingen, Lower Saxony, Germany
Bonn, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Mainz, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Pécs, , Hungary
Rome, Lazio, Italy
Genoa, Liguria, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Cagliari, Sardinia, Italy
Sassari, Sardinia, Italy
Florence, Tuscany, Italy
Padua, Veneto, Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
Bydgoszcz, , Poland
Gdansk, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Coimbra, , Portugal
Leiria, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Vila Franca de Xira, , Portugal
Bratislava, , Slovakia
Bratislava, , Slovakia
Nitra, , Slovakia
Zvolen, , Slovakia
Žilina, , Slovakia
L'Hospitalet de Llobregat, Barcelona, Spain
San Cugat Del Vallès, Barcelona, Spain
Albacete, , Spain
Barcelona, , Spain
Barcelona, , Spain
Valencia, , Spain
Bern, , Switzerland
Geneva, , Switzerland
Southampton, Hampshire, United Kingdom
Camberley, Surrey, United Kingdom
Guildford, Surrey, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Sunderland, Tyne and Wear, United Kingdom
Leeds, West Yorkshire, United Kingdom
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2014-005119-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17850
Identifier Type: -
Identifier Source: org_study_id
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