Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
NCT ID: NCT00637377
Last Updated: 2014-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1240 participants
INTERVENTIONAL
2008-04-30
2011-08-31
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
QUADRUPLE
Study Groups
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Ranibizumab 0.5mg Q4
Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Ranibizumab
Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Interventions
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Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Ranibizumab
Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Men and women \>/=50 years of age.
* Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by Fluorescein angiography (FA) in the study eye.
* ETDRS Best-Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters.
* Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
* Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.
Exclusion Criteria
* Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
* Any prior treatment with anti-VEGF agents in the study eye.
* Total lesion size \>12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
* Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
* Scar or fibrosis making up \>50% of the total lesion in the study eye.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
* History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
* Presence of other causes of CNV in the study eye.
* Prior vitrectomy in the study eye.
* History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
* Any history of macular hole of stage 2 and above in the study eye.
* Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
* History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
50 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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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Córdoba, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Chatswood, New South Wales, Australia
Sydney, New South Wales, Australia
Westmead, New South Wales, Australia
East Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Nedlands, Western Australia, Australia
Parramatta, , Australia
Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Liège, , Belgium
Ribeirão Preto, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Minas Gerais, , Brazil
Medellín, Antioquia, Colombia
Bogotá, Bogota D.C., Colombia
Cali, Cauca Department, Colombia
Brno, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Paris, Cedex 12, France
Nantes, Cedex 1, France
Besançon, , France
Bordeaux, , France
Dijon, , France
Lyon, , France
Lyon, , France
Marseille, , France
Paris, , 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
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
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
Veszprém, , Hungary
Ahemedabad - 4, Gujarat, India
Wadala, Mumbai, Maharashtra, India
Chennai, Tamil Nadu, India
Coimbatore, Tamil Nadu, India
Madurai, Tamil Nadu, India
Pondicherry, Tamil Nadu, India
Bangalore, , India
Chandigarh, , India
Hyderabad, , India
Kerala, , India
Kolkata, , India
Mumbai, , India
New Delhi, , India
New Delhi, , India
Orissa, , India
Haifa, Israel, Israel
Kfar Saba, Israel, Israel
Petah Tikva, Israel, Israel
Zrifin, Israel, Israel
Afula, , Israel
Beersheba, , Israel
Jerusalem, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Ancona, , Italy
Bari, , Italy
Catania, , Italy
Genova, , Italy
Milan, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Torino, , Italy
Udine, , Italy
Varese, , Italy
Verona, , Italy
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Urayasu, Chiba, Japan
Fukuoka, Fukuoka, Japan
Fukushima, Fukushima, Japan
Maebashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Kita, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kyoto, Kyoto, Japan
Hirakata, Osaka, Japan
Suita, Osaka, Japan
Ōtsu, Shiga, Japan
Chiyoda-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Chihuahua City, Chihuahua, Mexico
Zapopan, Jalisco, Mexico
Mexico City, Mexico City, Mexico
Monterrey, Nuevo León, Mexico
Monterrey, Nuevo León, Mexico
Metepec, State of Mexico, Mexico
Mexico City, , Mexico
México D.F., , Mexico
Leiden, ZA, Netherlands
Amsterdam, , Netherlands
Groningen, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Bydgoszcz, , Poland
Gdansk, , Poland
Katowice, , Poland
Poznan, , Poland
Warsaw, , Poland
Warszaa, , Poland
Wroclaw, , Poland
Coimbra, , Portugal
Porto, , Portugal
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Seongnam, Gyeonggido, South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Santiago de Compostela, A Coruña, Spain
Alicante, Alicante, Spain
Madrid, Madrid, Spain
Pamplona, Navarre, Spain
Oviedo, Principality of Asturias, Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Seville, , Spain
Seville, , Spain
Valencia, , Spain
Valencia, , Spain
Valladolid, , Spain
Linköping, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Basel, , Switzerland
Bern, , Switzerland
Geneva, , Switzerland
Zurich, , Switzerland
Southampton, Hampshire, United Kingdom
Camberley, Surrey, United Kingdom
Aberdeen, , United Kingdom
Belfast, , United Kingdom
Birmingham, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Plymouth, , United Kingdom
Torquay, , United Kingdom
Countries
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References
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Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17.
Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29.
Lukacs R, Schneider M, Nagy ZZ, Sandor GL, Kaan K, Asztalos A, Enyedi L, Pek G, Barcsay G, Szabo A, Borbandy A, Kovacs I, Resch MD, Papp A. Seven-year outcomes following intensive anti-vascular endothelial growth factor therapy in patients with exudative age-related macular degeneration. BMC Ophthalmol. 2023 Mar 17;23(1):110. doi: 10.1186/s12886-023-02843-2.
Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.
Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.
Ogura Y, Terasaki H, Gomi F, Yuzawa M, Iida T, Honda M, Nishijo K, Sowade O, Komori T, Schmidt-Erfurth U, Simader C, Chong V; VIEW 2 Investigators. Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study. Br J Ophthalmol. 2015 Jan;99(1):92-7. doi: 10.1136/bjophthalmol-2014-305076. Epub 2014 Aug 8.
Related Links
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Click here to view the data of the twin trial conducted by the collaboration partner.
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2007-000583-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
91689
Identifier Type: -
Identifier Source: org_study_id