Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
NCT ID: NCT01012973
Last Updated: 2014-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
177 participants
INTERVENTIONAL
2009-10-31
2012-02-29
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
TRIPLE
Study Groups
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Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.
Sham treatment
Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.
Sham treatment
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
Sham treatment
Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.
Interventions
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Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.
Sham treatment
Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.
Eligibility Criteria
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Inclusion Criteria
* Adults ≥ 18 years
* Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye
Exclusion Criteria
* Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
* CRVO disease duration \> 9 months from date of diagnosis
* Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
* Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
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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Chatswood, New South Wales, Australia
Parramatta, New South Wales, Australia
Sydney, New South Wales, Australia
Westmead, New South Wales, Australia
East Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Paris, Cedex 12, France
Nantes, Cedex 1, France
Bordeaux, , France
Dijon, , France
Marseille, , France
Paris, , France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Darmstadt, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Marburg, Hesse, Germany
Göttingen, Lower Saxony, Germany
Aachen, North Rhine-Westphalia, Germany
Bonn, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Chemnitz, Saxony, Germany
Dresden, Saxony, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Kiel, Schleswig-Holstein, Germany
Lübeck, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Veszprém, , Hungary
Zalaegerszeg, , Hungary
Ancona, , Italy
Bari, , Italy
Catania, , Italy
Florence, , Italy
Milan, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Roma, , Italy
Roma, , Italy
Torino, , Italy
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Urayasu, Chiba, Japan
Kyoto, Kyoto, Japan
Suita, Osaka, Japan
Chiyoda-ku, Tokyo, Japan
Riga, , Latvia
Riga, , Latvia
Singapore, , Singapore
Singapore, , Singapore
Seongnam-si, Gyeonggido, South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Countries
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References
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Holz FG, Roider J, Ogura Y, Korobelnik JF, Simader C, Groetzbach G, Vitti R, Berliner AJ, Hiemeyer F, Beckmann K, Zeitz O, Sandbrink R. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013 Mar;97(3):278-84. doi: 10.1136/bjophthalmol-2012-301504. Epub 2013 Jan 7.
Korobelnik JF, Holz FG, Roider J, Ogura Y, Simader C, Schmidt-Erfurth U, Lorenz K, Honda M, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study. Ophthalmology. 2014 Jan;121(1):202-208. doi: 10.1016/j.ophtha.2013.08.012. Epub 2013 Sep 29.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2009-010973-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14130
Identifier Type: -
Identifier Source: org_study_id
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