Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
VIEW 2
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)
2 other identifiers
interventional
1,240
25 countries
186
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2008
Typical duration for phase_3
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 18, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
January 23, 2012
CompletedDecember 12, 2014
November 1, 2014
2.4 years
March 12, 2008
December 16, 2011
November 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At week 52
Secondary Outcomes (4)
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF
Baseline and at week 52
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF
At week 52
Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF
Baseline and at week 52
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF
Baseline and at week 52
Study Arms (4)
Ranibizumab 0.5mg Q4
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (189)
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1015ABO, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1023AAQ, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1122AAI, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1181ACH, Argentina
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Córdoba, Córdoba Province, X5000IIT, Argentina
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Rosario, Santa Fe Province, S2000ANJ, Argentina
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Chatswood, New South Wales, 2067, Australia
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Sydney, New South Wales, 2000, Australia
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Westmead, New South Wales, 2145, Australia
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East Melbourne, Victoria, 3002, Australia
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Parkville, Victoria, 3050, Australia
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Nedlands, Western Australia, 6009, Australia
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Parramatta, 2150, Australia
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Innsbruck, 6020, Austria
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Linz, 4021, Austria
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Vienna, 1090, Austria
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Liège, 4000, Belgium
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Ribeirão Preto, São Paulo, 14048-900, Brazil
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São Paulo, São Paulo, 04023-062, Brazil
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São Paulo, São Paulo, 05651-901, Brazil
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Minas Gerais, 30150-270, Brazil
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Medellín, Antioquia, Colombia
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Bogotá, Bogota D.C., Colombia
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Cali, Cauca Department, Colombia
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Brno, 63400, Czechia
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Olomouc, 77520, Czechia
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Prague, 10034, Czechia
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Prague, 14000, Czechia
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Ústí nad Labem, 401 13, Czechia
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Paris, Cedex 12, 75557, France
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Nantes, Cedex 1, 44093, France
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Besançon, 25030, France
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Bordeaux, 33000, France
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Dijon, 21079, France
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Lyon, 69003, France
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Lyon, 69006, France
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Marseille, 13008, France
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Paris, 75010, France
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Paris, 75015, France
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Heidelberg, Baden-Wurttemberg, 69120, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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München, Bavaria, 81675, Germany
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Regensburg, Bavaria, 93053, Germany
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Hamburg, Hamburg, 20251, Germany
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Darmstadt, Hesse, 64297, Germany
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Aachen, North Rhine-Westphalia, 52074, Germany
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Bonn, North Rhine-Westphalia, 53105, Germany
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Cologne, North Rhine-Westphalia, 50924, Germany
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Essen, North Rhine-Westphalia, 45122, Germany
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Münster, North Rhine-Westphalia, 48145, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Homburg, Saarland, 66421, Germany
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Dresden, Saxony, 01307, Germany
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Dresden, Saxony, 06067, Germany
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Leipzig, Saxony, 04103, Germany
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Kiel, Schleswig-Holstein, 24105, Germany
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Lübeck, Schleswig-Holstein, 23538, Germany
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Berlin, State of Berlin, 12200, Germany
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Budapest, 1083, Hungary
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Budapest, 1106, Hungary
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Budapest, 1133, Hungary
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Veszprém, 8200, Hungary
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Ahemedabad - 4, Gujarat, 380009, India
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Wadala, Mumbai, Maharashtra, 400031, India
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Chennai, Tamil Nadu, 600 006, India
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Coimbatore, Tamil Nadu, 641014, India
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Madurai, Tamil Nadu, 625 020, India
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Pondicherry, Tamil Nadu, 600007, India
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Bangalore, 560010, India
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Chandigarh, 160012, India
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Hyderabad, 500 034, India
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Kerala, 683572, India
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Kolkata, 700073, India
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Mumbai, 400 050, India
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New Delhi, 110002, India
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New Delhi, 110029, India
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Orissa, 751 024, India
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Haifa, Israel, 34362, Israel
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Kfar Saba, Israel, Israel
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Petah Tikva, Israel, 49100, Israel
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Zrifin, Israel, 70300, Israel
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Afula, Israel
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Beersheba, Israel
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Jerusalem, 91120, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, Israel
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Ancona, 60126, Italy
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Bari, 70124, Italy
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Catania, 95123, Italy
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Genova, 16132, Italy
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Milan, 20122, Italy
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Milan, 20132, Italy
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Milan, 20157, Italy
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Padua, 35128, Italy
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Roma, 00133, Italy
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Roma, 00168, Italy
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Roma, 00198, Italy
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Torino, 10122, Italy
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Udine, 33100, Italy
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Varese, 21100, Italy
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Verona, 37121, Italy
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Nagoya, Aichi-ken, 466-8560, Japan
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Nagoya, Aichi-ken, 467-8602, Japan
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Urayasu, Chiba, 279-0021, Japan
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Fukuoka, Fukuoka, 812-8582, Japan
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Fukushima, Fukushima, 960-1295, Japan
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Maebashi, Gunma, 371-8511, Japan
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Sapporo, Hokkaido, 060-8604, Japan
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Kita, Kagawa-ken, 761-0793, Japan
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Kagoshima, Kagoshima-ken, 890-8520, Japan
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Kyoto, Kyoto, 606-8507, Japan
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Hirakata, Osaka, 573-1191, Japan
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Suita, Osaka, 565-0871, Japan
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Ōtsu, Shiga, 520-2192, Japan
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Chiyoda-ku, Tokyo, 101-8309, Japan
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Shinjuku-ku, Tokyo, 160-8582, Japan
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Riga, 1002, Latvia
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Riga, 1009, Latvia
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Riga, 1050, Latvia
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Chihuahua City, Chihuahua, 31238, Mexico
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Zapopan, Jalisco, 45060, Mexico
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Mexico City, Mexico City, 06800, Mexico
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Monterrey, Nuevo León, 64060, Mexico
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Monterrey, Nuevo León, 64480, Mexico
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Metepec, State of Mexico, 52140, Mexico
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Mexico City, 06030, Mexico
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México D.F., 04030, Mexico
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Leiden, ZA, 2333, Netherlands
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Amsterdam, 1100 DD, Netherlands
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Groningen, 9713 GZ, Netherlands
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Nijmegen, 6525 EX, Netherlands
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Rotterdam, 3000 CA, Netherlands
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Bydgoszcz, 85-631, Poland
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Gdansk, 80-952, Poland
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Katowice, 40-760, Poland
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Poznan, 61-848, Poland
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Warsaw, 00-416, Poland
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Warszaa, 02-005, Poland
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Wroclaw, 50-368, Poland
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Coimbra, 3000-548, Portugal
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Porto, 4200-319, Portugal
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Singapore, 119074, Singapore
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Singapore, 159964, Singapore
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Singapore, 168751, Singapore
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Singapore, 308433, Singapore
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Banská Bystrica, 97517, Slovakia
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Bratislava, 81369, Slovakia
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Seongnam, Gyeonggido, 463 707, South Korea
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Incheon, 405-760, South Korea
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Seoul, 110 744, South Korea
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Seoul, 137 701, South Korea
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Seoul, 138-736, South Korea
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Seoul, 152-703, South Korea
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Santiago de Compostela, A Coruña, 15705, Spain
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Alicante, Alicante, 03016, Spain
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Madrid, Madrid, 28002, Spain
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Pamplona, Navarre, 31008, Spain
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Oviedo, Principality of Asturias, 33012, Spain
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Barcelona, 08017, Spain
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Barcelona, 08022, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Valencia, 46014, Spain
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Valencia, 46015, Spain
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Valladolid, 47005, Spain
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Linköping, 58185, Sweden
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Örebro, 70185, Sweden
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Stockholm, 11282, Sweden
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Geneva, 1211, Switzerland
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Zurich, 8091, Switzerland
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Southampton, Hampshire, SO16 6YD, United Kingdom
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Camberley, Surrey, GU16 5UJ, United Kingdom
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Aberdeen, AB25 2ZN, United Kingdom
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Belfast, BT12 6BA, United Kingdom
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Birmingham, B4 7ET, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, NW1 5QH, United Kingdom
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London, SE5 9RS, United Kingdom
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Plymouth, PL4 6PL, United Kingdom
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Torquay, TQ2 7AA, United Kingdom
Related Publications (6)
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.
PMID: 23084240RESULTSchmidt-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.
PMID: 24084500RESULTLukacs 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.
PMID: 36932356DERIVEDMoshfeghi 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.
PMID: 31826853DERIVEDYuzawa 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.
PMID: 25439429DERIVEDOgura 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.
PMID: 25107900DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The conditional sequence of hypothesis testing had to stop after testing the first superiority hypothesis. Therefore, all further statistical tests are exploratory tests.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 18, 2008
Study Start
April 1, 2008
Primary Completion
September 1, 2010
Study Completion
August 1, 2011
Last Updated
December 12, 2014
Results First Posted
January 23, 2012
Record last verified: 2014-11