Trial record 1 of 1 for:    view2 macular degeneration
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Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00637377
First received: March 12, 2008
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Drug: Ranibizumab
Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: At week 52 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At week 52 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
    CNV area values measured in square millimeters; lower values represent better outcomes.


Enrollment: 1240
Study Start Date: April 2008
Study Completion Date: August 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
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.
Biological: 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.
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.
Biological: 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.
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.
Biological: 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637377

  Hide Study Locations
Locations
Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1181ACH
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1015ABO
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1023AAQ
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1122AAI
Rosario, Santa Fe, Argentina, S2000ANJ
Córdoba, Argentina, X5000IIT
Australia, New South Wales
Chatswood, New South Wales, Australia, 2067
Sydney, New South Wales, Australia, 2000
Westmead, New South Wales, Australia, 2145
Australia, Victoria
East Melbourne, Victoria, Australia, 3002
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Australia
Parramatta, Australia, 2150
Austria
Innsbruck, Austria, 6020
Linz, Austria, 4021
Wien, Austria, 1090
Belgium
Liege, Belgium, 4000
Brazil
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
São Paulo, Sao Paulo, Brazil, 05651-901
Minas Gerais, Brazil, 30150-270
Sao Paulo, Brazil, 04023-062
Colombia
Medellín, Antioquia, Colombia
Cali, Cauca, Colombia
Bogota, Distrito Capital de Bogotá, Colombia
Czech Republic
Brno, Czech Republic, 63400
Olomouc, Czech Republic, 77520
Praha 10, Czech Republic, 10034
Praha 4, Czech Republic, 14000
Usti nad Labem, Czech Republic, 401 13
France
Paris, Cedex 12, France, 75557
Nantes, Cedex 1, France, 44093
Besancon, France, 25030
Bordeaux, France, 33000
Dijon, France, 21079
Lyon, France, 69006
Lyon, France, 69003
Marseille, France, 13008
Paris, France, 75010
Paris, France, 75015
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Heidelberg, Baden-Württemberg, Germany, 69120
Tübingen, Baden-Württemberg, Germany, 72076
München, Bayern, Germany, 81675
Regensburg, Bayern, Germany, 93053
Darmstadt, Hessen, Germany, 64297
Aachen, Nordrhein-Westfalen, Germany, 52074
Bonn, Nordrhein-Westfalen, Germany, 53105
Essen, Nordrhein-Westfalen, Germany, 45122
Köln, Nordrhein-Westfalen, Germany, 50924
Münster, Nordrhein-Westfalen, Germany, 48145
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Mainz, Rheinland-Pfalz, Germany, 55131
Homburg, Saarland, Germany, 66421
Dresden, Sachsen, Germany, 01307
Dresden, Sachsen, Germany, 06067
Leipzig, Sachsen, Germany, 04103
Kiel, Schleswig-Holstein, Germany, 24105
Lübeck, Schleswig-Holstein, Germany, 23538
Berlin, Germany, 12200
Hamburg, Germany, 20251
Hungary
Budapest, Hungary, 1133
Budapest, Hungary, 1106
Budapest, Hungary, 1083
Veszprem, Hungary, 8200
India
Ahemedabad - 4, Gujrat, India, 380009
Wadala, Mumbai, Maharashtra, India, 400031
Chennai, Tamil Nadu, India, 600 006
Coimbatore, Tamil Nadu, India, 641014
Madurai, Tamil Nadu, India, 625 020
Pondicherry, Tamil Nadu, India, 600007
Bangalore, India, 560010
Chandigarh, India, 160012
Hyderabad, India, 500 034
Kerala, India, 683572
Kolkata, India, 700073
Mumbai, India, 400 050
New Delhi, India, 110002
New Delhi, India, 110029
Orissa, India, 751 024
Israel
Afula, Israel
Beer Sheva, Israel
Haifa, Israel, 34362
Jerusalem, Israel, 91120
Kfar Saba, Israel
Petach Tikva, Israel, 49100
Rehovot, Israel, 76100
Tel Aviv, Israel, 64239
Tel Hashomer, Israel
Zrifin, Israel, 70300
Italy
Ancona, Italy, 60126
Bari, Italy, 70124
Catania, Italy, 95123
Genova, Italy, 16132
Milano, Italy, 20157
Milano, Italy, 20122
Milano, Italy, 20132
Padova, Italy, 35128
Roma, Italy, 00168
Roma, Italy, 00198
Roma, Italy, 00133
Torino, Italy, 10122
Udine, Italy, 33100
Varese, Italy, 21100
Verona, Italy, 37121
Japan
Nagoya, Aichi, Japan, 466-8560
Nagoya, Aichi, Japan, 467-8602
Urayasu, Chiba, Japan, 279-0021
Maebashi, Gunma, Japan, 371-8511
Sapporo, Hokkaido, Japan, 060-8604
Kita, Kagawa, Japan, 761-0793
Hirakata, Osaka, Japan, 573-1191
Suita, Osaka, Japan, 565-0871
Otsu, Shiga, Japan, 520-2192
Chiyoda-ku, Tokyo, Japan, 101-8309
Shinjuku-ku, Tokyo, Japan, 160-8582
Fukuoka, Japan, 812-8582
Fukushima, Japan, 960-1295
Kagoshima, Japan, 890-8520
Kyoto, Japan, 606-8507
Korea, Republic of
Seongnam, Gyeonggido, Korea, Republic of, 463 707
Incheon, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 110 744
Seoul, Korea, Republic of, 152-703
Seoul, Korea, Republic of, 137 701
Latvia
Riga, Latvia, 1050
Riga, Latvia, 1009
Riga, Latvia, 1002
Mexico
Mexico City, Distrito Federal, Mexico, 06800
Zapopan, Jalisco, Mexico, 45060
Metepec, México, Mexico, 52140
Monterrey, Nuevo Leon, Mexico, 64060
Monterrey, Nuevo Leon, Mexico, 64480
Chihuahua, Mexico, 31238
Mexico City, Mexico, 06030
México D.F., Mexico, 04030
Netherlands
Leiden, ZA, Netherlands, 2333
Amsterdam, Netherlands, 1100 DD
Groningen, Netherlands, 9713 GZ
Nijmegen, Netherlands, 6525 EX
Rotterdam, Netherlands, 3000 CA
Poland
Bydgoszcz, Poland, 85-631
Gdansk, Poland, 80-952
Katowice, Poland, 40-760
Poznan, Poland, 61-848
Warszaa, Poland, 02-005
Warszawa, Poland, 00-416
Wroclaw, Poland, 50-368
Portugal
Coimbra, Portugal, 3000-548
Porto, Portugal, 4200-319
Singapore
Singapore, Singapore, 159964
Singapore, Singapore, 308433
Singapore, Singapore, 119074
Singapore, Singapore, 168751
Slovakia
Banska Bystrica, Slovakia, 97517
Bratislava, Slovakia, 81369
Spain
Santiago de Compostela, A Coruña, Spain, 15705
Oviedo, Asturias, Spain, 33012
Pamplona, Navarra, Spain, 31008
Alicante, Spain, 03016
Barcelona, Spain, 08017
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Barcelona, Spain, 08022
Madrid, Spain, 28002
Madrid, Spain, 28046
Malaga, Spain, 29010
Sevilla, Spain, 41013
Sevilla, Spain, 41009
Valencia, Spain, 46015
Valencia, Spain, 46014
Valladolid, Spain, 47005
Sweden
Linköping, Sweden, 58185
Stockholm, Sweden, 11282
Örebro, Sweden, 70185
Switzerland
Basel, Switzerland, 4031
Bern, Switzerland, 3010
Genève, Switzerland, 1211
Zürich, Switzerland, 8091
United Kingdom
Southampton, Hampshire, United Kingdom, SO16 6YD
Camberley, Surrey, United Kingdom, GU16 5UJ
Aberdeen, United Kingdom, AB25 2ZN
Belfast, United Kingdom, BT12 6BA
Birmingham, United Kingdom, B4 7ET
Liverpool, United Kingdom, L7 8XP
London, United Kingdom, SE5 9RS
London, United Kingdom, NW1 5QH
Plymouth, United Kingdom, PL4 6PL
Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00637377     History of Changes
Other Study ID Numbers: 91689, 2007-000583-25
Study First Received: March 12, 2008
Results First Received: December 16, 2011
Last Updated: April 25, 2014
Health Authority: Switzerland: Swiss Medic
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: ANVISA Agencia Nacional de Vigilancia Sanitaria
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Latvia: State Agency of Medicines
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED National Authority of Medicines and Health Products
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:
Eye diseases
Vision Impairment and Blindness
Eyes and Vision
Seniors
Neovascular Age-Related Macular Degeneration (AMD)
Retinal Disease

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014