Back to resultsVascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2)
Primary Purpose
Macular Degeneration
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ranibizumab
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Eye diseases, Vision Impairment and Blindness, Eyes and Vision, Seniors, Neovascular Age-Related Macular Degeneration (AMD), Retinal Disease
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- 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 ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Ranibizumab 0.5mg Q4
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
Maintenance of vision was defined as a loss of < 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Secondary Outcome Measures
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF
The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF
CNV area values measured in square millimeters; lower values represent better outcomes.
Full Information
NCT ID
NCT00637377
First Posted
March 12, 2008
Last Updated
November 28, 2014
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00637377
Brief Title
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
Acronym
VIEW 2
Official Title
A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.
Detailed Description
Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Eye diseases, Vision Impairment and Blindness, Eyes and Vision, Seniors, Neovascular Age-Related Macular Degeneration (AMD), Retinal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab 0.5mg Q4
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
Arm Type
Experimental
Arm Description
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.
Arm Title
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
Arm Type
Experimental
Arm Description
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.
Arm Title
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
Description
Maintenance of vision was defined as a loss of < 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame
At week 52
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF
Description
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Time Frame
Baseline and at week 52
Title
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF
Description
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame
At week 52
Title
Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF
Description
The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).
Time Frame
Baseline and at week 52
Title
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF
Description
CNV area values measured in square millimeters; lower values represent better outcomes.
Time Frame
Baseline and at week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent.
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 ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1023AAQ
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1122AAI
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000ANJ
Country
Argentina
City
Córdoba
ZIP/Postal Code
X5000IIT
Country
Argentina
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Parramatta
ZIP/Postal Code
2150
Country
Australia
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4021
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048-900
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
City
Minas Gerais
ZIP/Postal Code
30150-270
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
City
Medellín
State/Province
Antioquia
Country
Colombia
City
Cali
State/Province
Cauca
Country
Colombia
City
Bogota
State/Province
Distrito Capital de Bogotá
Country
Colombia
City
Brno
ZIP/Postal Code
63400
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
City
Praha 4
ZIP/Postal Code
14000
Country
Czech Republic
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
City
Paris
State/Province
Cedex 12
ZIP/Postal Code
75557
Country
France
City
Nantes
State/Province
Cedex 1
ZIP/Postal Code
44093
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Dijon
ZIP/Postal Code
21079
Country
France
City
Lyon
ZIP/Postal Code
69003
Country
France
City
Lyon
ZIP/Postal Code
69006
Country
France
City
Marseille
ZIP/Postal Code
13008
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Paris
ZIP/Postal Code
75015
Country
France
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64297
Country
Germany
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
06067
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Ahemedabad - 4
State/Province
Gujrat
ZIP/Postal Code
380009
Country
India
City
Wadala, Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400031
Country
India
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 006
Country
India
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641014
Country
India
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India
City
Pondicherry
State/Province
Tamil Nadu
ZIP/Postal Code
600007
Country
India
City
Bangalore
ZIP/Postal Code
560010
Country
India
City
Chandigarh
ZIP/Postal Code
160012
Country
India
City
Hyderabad
ZIP/Postal Code
500 034
Country
India
City
Kerala
ZIP/Postal Code
683572
Country
India
City
Kolkata
ZIP/Postal Code
700073
Country
India
City
Mumbai
ZIP/Postal Code
400 050
Country
India
City
New Delhi
ZIP/Postal Code
110002
Country
India
City
New Delhi
ZIP/Postal Code
110029
Country
India
City
Orissa
ZIP/Postal Code
751 024
Country
India
City
Afula
Country
Israel
City
Beer Sheva
Country
Israel
City
Haifa
ZIP/Postal Code
34362
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Kfar Saba
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Tel Hashomer
Country
Israel
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
City
Ancona
ZIP/Postal Code
60126
Country
Italy
City
Bari
ZIP/Postal Code
70124
Country
Italy
City
Catania
ZIP/Postal Code
95123
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Milano
ZIP/Postal Code
20157
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Roma
ZIP/Postal Code
00133
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Roma
ZIP/Postal Code
00198
Country
Italy
City
Torino
ZIP/Postal Code
10122
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Verona
ZIP/Postal Code
37121
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
City
Urayasu
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
City
Kita
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
463 707
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110 744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137 701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
City
Riga
ZIP/Postal Code
1002
Country
Latvia
City
Riga
ZIP/Postal Code
1009
Country
Latvia
City
Riga
ZIP/Postal Code
1050
Country
Latvia
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06800
Country
Mexico
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45060
Country
Mexico
City
Metepec
State/Province
México
ZIP/Postal Code
52140
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64480
Country
Mexico
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
City
Mexico City
ZIP/Postal Code
06030
Country
Mexico
City
México D.F.
ZIP/Postal Code
04030
Country
Mexico
City
Leiden
State/Province
ZA
ZIP/Postal Code
2333
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 EX
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Katowice
ZIP/Postal Code
40-760
Country
Poland
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
City
Warszaa
ZIP/Postal Code
02-005
Country
Poland
City
Warszawa
ZIP/Postal Code
00-416
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
City
Singapore
ZIP/Postal Code
159964
Country
Singapore
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15705
Country
Spain
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33012
Country
Spain
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
City
Alicante
ZIP/Postal Code
03016
Country
Spain
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28002
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
City
Stockholm
ZIP/Postal Code
11282
Country
Sweden
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Camberley
State/Province
Surrey
ZIP/Postal Code
GU16 5UJ
Country
United Kingdom
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
City
Birmingham
ZIP/Postal Code
B4 7ET
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
London
ZIP/Postal Code
NW1 5QH
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
Plymouth
ZIP/Postal Code
PL4 6PL
Country
United Kingdom
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23084240
Citation
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. Erratum In: Ophthalmology. 2013 Jan;120(1):209-10.
Results Reference
result
PubMed Identifier
24084500
Citation
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.
Results Reference
result
PubMed Identifier
31826853
Citation
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.
Results Reference
derived
PubMed Identifier
25439429
Citation
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.
Results Reference
derived
PubMed Identifier
25107900
Citation
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.
Results Reference
derived
Links:
URL
http://clinicaltrials.gov/ct2/show/NCT00509795?term=NCT00509795;rank=1
Description
Click here to view the data of the twin trial conducted by the collaboration partner.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
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