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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00637377




Registration number
NCT00637377
Ethics application status
Date submitted
12/03/2008
Date registered
18/03/2008
Date last updated
12/12/2014

Titles & IDs
Public title
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
Scientific 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)
Secondary ID [1] 0 0
2007-000583-25
Secondary ID [2] 0 0
91689
Universal Trial Number (UTN)
Trial acronym
VIEW 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab
Other interventions - Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Other interventions - Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Other interventions - Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Active Comparator: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.


Treatment: Drugs: 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.

Other interventions: 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.

Other interventions: 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.

Other interventions: 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.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
At week 52
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and at week 52
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
At week 52
Secondary outcome [3] 0 0
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).
Timepoint [3] 0 0
Baseline and at week 52
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline and at week 52

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Chatswood
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- East Melbourne
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- Nedlands
Recruitment hospital [7] 0 0
- Parramatta
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudad Auton. de Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Santa Fe
Country [3] 0 0
Argentina
State/province [3] 0 0
Córdoba
Country [4] 0 0
Austria
State/province [4] 0 0
Innsbruck
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Belgium
State/province [7] 0 0
Liege
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
Minas Gerais
Country [10] 0 0
Colombia
State/province [10] 0 0
Antioquia
Country [11] 0 0
Colombia
State/province [11] 0 0
Cauca
Country [12] 0 0
Colombia
State/province [12] 0 0
Distrito Capital de Bogotá
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Brno
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Olomouc
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Praha 10
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Praha 4
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Usti nad Labem
Country [18] 0 0
France
State/province [18] 0 0
Cedex 12
Country [19] 0 0
France
State/province [19] 0 0
Cedex 1
Country [20] 0 0
France
State/province [20] 0 0
Besancon
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Dijon
Country [23] 0 0
France
State/province [23] 0 0
Lyon
Country [24] 0 0
France
State/province [24] 0 0
Marseille
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
Germany
State/province [26] 0 0
Baden-Württemberg
Country [27] 0 0
Germany
State/province [27] 0 0
Bayern
Country [28] 0 0
Germany
State/province [28] 0 0
Hessen
Country [29] 0 0
Germany
State/province [29] 0 0
Nordrhein-Westfalen
Country [30] 0 0
Germany
State/province [30] 0 0
Rheinland-Pfalz
Country [31] 0 0
Germany
State/province [31] 0 0
Saarland
Country [32] 0 0
Germany
State/province [32] 0 0
Sachsen
Country [33] 0 0
Germany
State/province [33] 0 0
Schleswig-Holstein
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Veszprem
Country [38] 0 0
India
State/province [38] 0 0
Gujrat
Country [39] 0 0
India
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Maharashtra
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India
State/province [40] 0 0
Tamil Nadu
Country [41] 0 0
India
State/province [41] 0 0
Bangalore
Country [42] 0 0
India
State/province [42] 0 0
Chandigarh
Country [43] 0 0
India
State/province [43] 0 0
Hyderabad
Country [44] 0 0
India
State/province [44] 0 0
Kerala
Country [45] 0 0
India
State/province [45] 0 0
Kolkata
Country [46] 0 0
India
State/province [46] 0 0
Mumbai
Country [47] 0 0
India
State/province [47] 0 0
New Delhi
Country [48] 0 0
India
State/province [48] 0 0
Orissa
Country [49] 0 0
Israel
State/province [49] 0 0
Afula
Country [50] 0 0
Israel
State/province [50] 0 0
Beer Sheva
Country [51] 0 0
Israel
State/province [51] 0 0
Haifa
Country [52] 0 0
Israel
State/province [52] 0 0
Jerusalem
Country [53] 0 0
Israel
State/province [53] 0 0
Kfar Saba
Country [54] 0 0
Israel
State/province [54] 0 0
Petach Tikva
Country [55] 0 0
Israel
State/province [55] 0 0
Rehovot
Country [56] 0 0
Israel
State/province [56] 0 0
Tel Aviv
Country [57] 0 0
Israel
State/province [57] 0 0
Tel Hashomer
Country [58] 0 0
Israel
State/province [58] 0 0
Zrifin
Country [59] 0 0
Italy
State/province [59] 0 0
Ancona
Country [60] 0 0
Italy
State/province [60] 0 0
Bari
Country [61] 0 0
Italy
State/province [61] 0 0
Catania
Country [62] 0 0
Italy
State/province [62] 0 0
Genova
Country [63] 0 0
Italy
State/province [63] 0 0
Milano
Country [64] 0 0
Italy
State/province [64] 0 0
Padova
Country [65] 0 0
Italy
State/province [65] 0 0
Roma
Country [66] 0 0
Italy
State/province [66] 0 0
Torino
Country [67] 0 0
Italy
State/province [67] 0 0
Udine
Country [68] 0 0
Italy
State/province [68] 0 0
Varese
Country [69] 0 0
Italy
State/province [69] 0 0
Verona
Country [70] 0 0
Japan
State/province [70] 0 0
Aichi
Country [71] 0 0
Japan
State/province [71] 0 0
Chiba
Country [72] 0 0
Japan
State/province [72] 0 0
Gunma
Country [73] 0 0
Japan
State/province [73] 0 0
Hokkaido
Country [74] 0 0
Japan
State/province [74] 0 0
Kagawa
Country [75] 0 0
Japan
State/province [75] 0 0
Osaka
Country [76] 0 0
Japan
State/province [76] 0 0
Shiga
Country [77] 0 0
Japan
State/province [77] 0 0
Tokyo
Country [78] 0 0
Japan
State/province [78] 0 0
Fukuoka
Country [79] 0 0
Japan
State/province [79] 0 0
Fukushima
Country [80] 0 0
Japan
State/province [80] 0 0
Kagoshima
Country [81] 0 0
Japan
State/province [81] 0 0
Kyoto
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Gyeonggido
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Incheon
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Seoul
Country [85] 0 0
Latvia
State/province [85] 0 0
Riga
Country [86] 0 0
Mexico
State/province [86] 0 0
Distrito Federal
Country [87] 0 0
Mexico
State/province [87] 0 0
Jalisco
Country [88] 0 0
Mexico
State/province [88] 0 0
México
Country [89] 0 0
Mexico
State/province [89] 0 0
Nuevo Leon
Country [90] 0 0
Mexico
State/province [90] 0 0
Chihuahua
Country [91] 0 0
Mexico
State/province [91] 0 0
Mexico City
Country [92] 0 0
Mexico
State/province [92] 0 0
México D.F.
Country [93] 0 0
Netherlands
State/province [93] 0 0
ZA
Country [94] 0 0
Netherlands
State/province [94] 0 0
Amsterdam
Country [95] 0 0
Netherlands
State/province [95] 0 0
Groningen
Country [96] 0 0
Netherlands
State/province [96] 0 0
Nijmegen
Country [97] 0 0
Netherlands
State/province [97] 0 0
Rotterdam
Country [98] 0 0
Poland
State/province [98] 0 0
Bydgoszcz
Country [99] 0 0
Poland
State/province [99] 0 0
Gdansk
Country [100] 0 0
Poland
State/province [100] 0 0
Katowice
Country [101] 0 0
Poland
State/province [101] 0 0
Poznan
Country [102] 0 0
Poland
State/province [102] 0 0
Warszaa
Country [103] 0 0
Poland
State/province [103] 0 0
Warszawa
Country [104] 0 0
Poland
State/province [104] 0 0
Wroclaw
Country [105] 0 0
Portugal
State/province [105] 0 0
Coimbra
Country [106] 0 0
Portugal
State/province [106] 0 0
Porto
Country [107] 0 0
Singapore
State/province [107] 0 0
Singapore
Country [108] 0 0
Slovakia
State/province [108] 0 0
Banska Bystrica
Country [109] 0 0
Slovakia
State/province [109] 0 0
Bratislava
Country [110] 0 0
Spain
State/province [110] 0 0
A Coruña
Country [111] 0 0
Spain
State/province [111] 0 0
Asturias
Country [112] 0 0
Spain
State/province [112] 0 0
Navarra
Country [113] 0 0
Spain
State/province [113] 0 0
Alicante
Country [114] 0 0
Spain
State/province [114] 0 0
Barcelona
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Spain
State/province [116] 0 0
Malaga
Country [117] 0 0
Spain
State/province [117] 0 0
Sevilla
Country [118] 0 0
Spain
State/province [118] 0 0
Valencia
Country [119] 0 0
Spain
State/province [119] 0 0
Valladolid
Country [120] 0 0
Sweden
State/province [120] 0 0
Linköping
Country [121] 0 0
Sweden
State/province [121] 0 0
Stockholm
Country [122] 0 0
Sweden
State/province [122] 0 0
Örebro
Country [123] 0 0
Switzerland
State/province [123] 0 0
Basel
Country [124] 0 0
Switzerland
State/province [124] 0 0
Bern
Country [125] 0 0
Switzerland
State/province [125] 0 0
Genève
Country [126] 0 0
Switzerland
State/province [126] 0 0
Zürich
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Hampshire
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Surrey
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Aberdeen
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Belfast
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Birmingham
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Liverpool
Country [133] 0 0
United Kingdom
State/province [133] 0 0
London
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Plymouth
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00637377
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications