Trial Condition(s):

Macular degeneration

Vascular endothelial growth factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2)

Bayer Identifier:

91689

ClinicalTrials.gov Identifier:

NCT00637377

EudraCT Number:

2007-000583-25

Study Completed

Trial 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.

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.

Trial Summary

Enrollment Goal
1240
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Universitätsklinikum Freiburg

Freiburg, Germany, 79106

Status
Completed
 
Locations

St. Franziskus-Hospital GmbH

Münster, Germany, 48145

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

Universitätsklinikum Aachen

Aachen, Germany, 52074

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20251

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Completed
 
Locations

Universitätsklinikum Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

Krankenhaus Dresden-Friedrichstadt

Dresden, Germany, 06067

Status
Completed
 
Locations

Royal Liverpool University Hospital

Liverpool, United Kingdom, L7 8XP

Status
Completed
 
Locations

Kings College Hospital

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

Western Eye Hospital

London, United Kingdom, NW1 5QH

Status
Completed
 
Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Status
Completed
 
Locations

Queen's University

Belfast, United Kingdom, BT12 6BA

Status
Completed
 
Locations

Plymouth Hospitals NHS Trust R&D

Plymouth, United Kingdom, PL4 6PL

Status
Completed
 
Locations

Aston University

Birmingham, United Kingdom, B4 7ET

Status
Completed
 
Locations

Centre Hospitalier National d'Ophthalmologie Quinze-Vingt

Paris, France, 75557

Status
Completed
 
Locations

Centre Ophthalmologique Rabelais

Lyon, France, 69003

Status
Completed
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50924

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

Universitätskliniken des Saarlandes

Homburg, Germany, 66421

Status
Completed
 
Locations

Klinikum Darmstadt

Darmstadt, Germany, 64297

Status
Completed
 
Locations

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany, 67063

Status
Completed
 
Locations

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

Torbay Hospital

Torquay, United Kingdom, TQ2 7AA

Status
Completed
 
Locations

Frimley Park Hospital NHS

Camberley, United Kingdom, GU16 5UJ

Status
Completed
 
Locations

Centre d'Ophtalmologie Monticelli

Marseille, France, 13008

Status
Completed
 
Locations

Hopital Lariboisiere

Paris, France, 75010

Status
Completed
 
Locations

Centre de Res en Ophthalmologie

Lyon, France, 69006

Status
Completed
 
Locations

C.H.U. Pellegrin

Bordeaux, France, 33000

Status
Completed
 
Locations

Hôpital Hôtel Dieu - Nantes Cedex

Nantes, France, 44093

Status
Completed
 
Locations

Centre hospitalier universitaire de Besancon

Besancon, France, 25030

Status
Completed
 
Locations

SMPK, SPSK im. Prof. W. Orlowskiego

Warszawa, Poland, 00-416

Status
Completed
 
Locations

Centre Ophthalmologie d'Imagerie et de Laser

Paris, France, 75015

Status
Completed
 
Locations

Centre Hospitalier Universitaire de Dijon

Dijon, France, 21079

Status
Completed
 
Locations

Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen

Warszaa, Poland, 02-005

Status
Completed
 
Locations

Klinika Okulistyki

Wroclaw, Poland, 50-368

Status
Completed
 
Locations

Gunma University Hospital

Maebashi, Japan, 371-8511

Status
Completed
 
Locations

Shiga University of Medical Science Hospital

Otsu, Japan, 520-2192

Status
Completed
 
Locations

Sapporo City General Hospital

Sapporo, Japan, 060-8604

Status
Completed
 
Locations

Nagoya University Hospital

Nagoya, Japan, 466-8560

Status
Completed
 
Locations

Kyoto University Hospital

Kyoto, Japan, 606-8507

Status
Completed
 
Locations

Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

Status
Completed
 
Locations

Kagoshima University Medical and Dental Hospital

Kagoshima, Japan, 890-8520

Status
Completed
 
Locations

Kagawa University Hospital

Kita, Japan, 761-0793

Status
Completed
 
Locations

Osaka University Hospital

Suita, Japan, 565-0871

Status
Completed
 
Locations

ASL RM/A Roma - Lazio

Roma, Italy, 00198

Status
Completed
 
Locations

A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

Status
Completed
 
Locations

Szpiatal Kliniczny nr 1 Przemienienia Panskiego

Poznan, Poland, 61-848

Status
Completed
 
Locations

Klinika Chorob Oczu

Gdansk, Poland, 80-952

Status
Completed
 
Locations

Okregowy Szpital Kolejowy

Katowice, Poland, 40-760

Status
Completed
 
Locations

NZOZ "OFTALMIKA"

Bydgoszcz, Poland, 85-631

Status
Completed
 
Locations

Keio University Hospital

Shinjuku-ku, Japan, 160-8582

Status
Completed
 
Locations

Nagoya City University Hospital

Nagoya, Japan, 467-8602

Status
Completed
 
Locations

Juntendo University Urayasu Hospital

Urayasu, Japan, 279-0021

Status
Completed
 
Locations

Surugadai Nihon University Hospital

Chiyoda-ku, Japan, 101-8309

Status
Completed
 
Locations

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Kansai Medical University Hirakata Hospital

Hirakata, Japan, 573-1191

Status
Completed
 
Locations

Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Status
Completed
 
Locations

A.O.U. Policlinico Consorziale

Bari, Italy, 70124

Status
Completed
 
Locations

IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro

Genova, Italy, 16132

Status
Completed
 
Locations

A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi

Ancona, Italy, 60126

Status
Completed
 
Locations

A.O. Sacco Polo Universitario

Milano, Italy, 20157

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

Status
Completed
 
Locations

Ospedale Maggiore Borgo Trento

Verona, Italy, 37121

Status
Terminated
 
Locations

Hospital Nuestra Senora de la Esperanza

Santiago de Compostela, Spain, 15705

Status
Completed
 
Locations

Vissum Corporacion Alicante

Alicante, Spain, 03016

Status
Completed
 
Locations

VISSUM

Madrid, Spain, 28002

Status
Completed
 
Locations

Instituto Oftalmológico de Barcelona

Barcelona, Spain, 08017

Status
Completed
 
Locations

Hospital General de Malaga

Malaga, Spain, 29010

Status
Completed
 
Locations

Fundación Oftalmológica del Mediterraneo

Valencia, Spain, 46015

Status
Completed
 
Locations

Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333

Status
Completed
 
Locations

Erasmus Medisch Centrum

Rotterdam, Netherlands, 3000 CA

Status
Completed
 
Locations

Instituto de Oftalmología

Mexico City, Mexico, 06800

Status
Completed
 
Locations

Hospital Universitario "José Eleuterio González"

Monterrey, Mexico, 64480

Status
Completed
 
Locations

Centro Medico ISSEMYM

Metepec, Mexico, 52140

Status
Terminated
 
Locations

Fundacion Hospital Nuestra Señora de la Luz

Mexico City, Mexico, 06030

Status
Completed
 
Locations

IRCCS Fond. Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

ASL TO/2 - Piemonte

Torino, Italy, 10122

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

A.O.U. Policlinico - Vittorio Emanuele

Catania, Italy, 95123

Status
Completed
 
Locations

A.O.U. Policlinico Tor Vergata

Roma, Italy, 00133

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

Instituto Universitario de Oftalmobiología Aplicada

Valladolid, Spain, 47005

Status
Completed
 
Locations

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Status
Completed
 
Locations

Hospital Universitario Virgen de la Macarena

Sevilla, Spain, 41009

Status
Completed
 
Locations

Instituto Oftalmologico Fernandez Vega

Oviedo, Spain, 33012

Status
Completed
 
Locations

Clínica Universitaria de Navarra

Pamplona, Spain, 31008

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Clínica Piñero

Sevilla, Spain, 41013

Status
Completed
 
Locations

Centro Medico Teknon

Barcelona, Spain, 08022

Status
Completed
 
Locations

Asociación para Evitar la Ceguera en México, I. A. P.

México D.F., Mexico, 04030

Status
Completed
 
Locations

St Eriks Eye Hospital

Stockholm, Sweden, 11282

Status
Completed
 
Locations

Eye Clinic

Örebro, Sweden, 70185

Status
Completed
 
Locations

Masaryk Hospital Usti n/L

Usti nad Labem, Czech Republic, 401 13

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel

Status
Completed
 
Locations

Kaplan Medical Center

Rehovot, Israel, 76100

Status
Completed
 
Locations

Haemek Medical Center

Afula, Israel

Status
Completed
 
Locations

Marsden Eye Surgery Center

Parramatta, Australia, 2150

Status
Completed
 
Locations

Royal Melbourne Hospital

Parkville, Australia, 3050

Status
Completed
 
Locations

Save Sight Institute

Sydney, Australia, 2000

Status
Completed
 
Locations

Lion Eye Institute

Nedlands, Australia, 6009

Status
Completed
 
Locations

Eye Clinic Westmead Hospital

Westmead, Australia, 2145

Status
Completed
 
Locations

Oftalmólogos especialistas

Rosario, Argentina, S2000ANJ

Status
Completed
 
Locations

Hospital Italiano Buenos Aires

Buenos Aires, Argentina, C1181ACH

Status
Completed
 
Locations

CHU de Liège

Liege, Belgium, 4000

Status
Completed
 
Locations

University Medical Center St. Radboud

Nijmegen, Netherlands, 6525 EX

Status
Completed
 
Locations

Academic Medical Center Dept Ophthalmology

Amsterdam, Netherlands, 1100 DD

Status
Terminated
 
Locations

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Status
Completed
 
Locations

Hospital CIMA Chihuahua

Chihuahua, Mexico, 31238

Status
Completed
 
Locations

Centro Oftalmologico de Guadalajara

Zapopan, Mexico, 45060

Status
Completed
 
Locations

Centro Médico Hidalgo

Monterrey, Mexico, 64060

Status
Completed
 
Locations

Eye Clinic

Linköping, Sweden, 58185

Status
Completed
 
Locations

Fakultni nemocnice Brno

Brno, Czech Republic, 63400

Status
Completed
 
Locations

Vseobecna Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 77520

Status
Completed
 
Locations

Ocni klinika Lexum

Praha 4, Czech Republic, 14000

Status
Completed
 
Locations

Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 10034

Status
Completed
 
Locations

Hebrew University - Hadassah Medical School

Jerusalem, Israel, 91120

Status
Completed
 
Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Organizacion Medica de Investigacion (OMI)

Buenos Aires, Argentina, C1015ABO

Status
Completed
 
Locations

Csolnoky Ferenc Hospital

Veszprem, Hungary, 8200

Status
Completed
 
Locations

Bajcsy Zsilinszky Hospital

Budapest, Hungary, 1106

Status
Completed
 
Locations

Budapest Retina Associates

Budapest, Hungary, 1133

Status
Completed
 
Locations

Clínica Oftalmológica San Diego

Medellín, Colombia

Status
Completed
 
Locations

Fundación Oftalmológica Nacional

Bogota, Colombia

Status
Completed
 
Locations

Instituto da Visao

Minas Gerais, Brazil, 30150-270

Status
Completed
 
Locations

Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-901

Status
Completed
 
Locations

Seoul National University Bundang Hospital

Seongnam, South Korea, 463 707

Status
Completed
 
Locations

Seoul St. Mary's Hospital

Seoul, South Korea, 137 701

Status
Completed
 
Locations

Korea University Guro Hospital

Seoul , South Korea, 152-703

Status
Completed
 
Locations

Universitätsspital Zürich

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1211

Status
Completed
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Completed
 
Locations

L.V. Prasad Eye Institute

Orissa, India, 751 024

Status
Completed
 
Locations

Rabin Medical Center

Petach Tikva, Israel, 49100

Status
Completed
 
Locations

Assaf Harofeh Medical Center

Zrifin, Israel, 70300

Status
Completed
 
Locations

Meir Medical Center

Kfar Saba, Israel

Status
Completed
 
Locations

Soroka University Medical Center

Beer Sheva, Israel

Status
Completed
 
Locations

Lady Davis Carmel Medical Center

Haifa, Israel, 34362

Status
Completed
 
Locations

Centre for Eye Research

East Melbourne, Australia, 3002

Status
Completed
 
Locations

Vision Eye Institute

Chatswood, Australia, 2067

Status
Completed
 
Locations

Hospital de Sao Joao - Centro Hospitalar de Sao Joao, EPE

Porto, Portugal, 4200-319

Status
Completed
 
Locations

AIBILI Azinhaga de Santa

Coimbra, Portugal, 3000-548

Status
Completed
 
Locations

Praxis Dr. Domingo Tacite

Córdoba, Argentina, X5000IIT

Status
Completed
 
Locations

Fundación Zambrano

Buenos Aires, Argentina, C1023AAQ

Status
Completed
 
Locations

Instituto de la Visión S.A.

Buenos Aires, Argentina, C1122AAI

Status
Completed
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Konventhospital Barmherzige Brüder Linz

Linz, Austria, 4021

Status
Completed
 
Locations

Dr.R.P. Center for Ophthalmic Sciences

New Delhi, India, 110029

Status
Completed
 
Locations

Post Graduate Institute of Medical Education and Research

Chandigarh, India, 160012

Status
Completed
 
Locations

Aravind Eye Hospital

Madurai, India, 625 020

Status
Completed
 
Locations

Aravind Eye Hospital

Coimbatore, India, 641014

Status
Completed
 
Locations

Retina Foundation

Ahemedabad - 4, India, 380009

Status
Completed
 
Locations

Shroff Eye Hospital

Mumbai, India, 400 050

Status
Completed
 
Locations

Alexandra Hospital

Singapore, Singapore, 159964

Status
Completed
 
Locations

Tan Tock Seng Hospital

Singapore, Singapore, 308433

Status
Completed
 
Locations

Dr. Solomatins Eye

Riga, Latvia, 1050

Status
Terminated
 
Locations

Latvijas-Amerikas acu centrs

Riga, Latvia, 1009

Status
Completed
 
Locations

University of Semmelweis

Budapest, Hungary, 1083

Status
Completed
 
Locations

Clínica Oftalmológica de Cali

Cali, Colombia

Status
Completed
 
Locations

Instituto Nacional de Investigación en Oftalmología

Medellín, Colombia

Status
Completed
 
Locations

Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

Ribeirão Preto, Brazil, 14048-900

Status
Completed
 
Locations

Hospital Sao Paulo - UNIFESP

Sao Paulo, Brazil, 04023-062

Status
Completed
 
Locations

Faculty Hospital F. D. Roosevelt

Banska Bystrica, Slovakia, 97517

Status
Completed
 
Locations

Univerzitná nemocnica Bratislava, Nemocnica Stare Mesto

Bratislava, Slovakia, 81369

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110 744

Status
Completed
 
Locations

Gachon University Gil Medical Center

Incheon, South Korea, 405-760

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Regional Institute of Ophthalmology

Kolkata, India, 700073

Status
Completed
 
Locations

L.V. Prasad Eye Institute

Hyderabad, India, 500 034

Status
Completed
 
Locations

Narayana Netralaya

Bangalore, India, 560010

Status
Completed
 
Locations

Shankar Netralaya

Chennai, India, 600 006

Status
Completed
 
Locations

Little Flower Hospital

Kerala, India, 683572

Status
Completed
 
Locations

Aravind Eye Hospital

Pondicherry, India, 600007

Status
Completed
 
Locations

Aditya Jyot Eye Hospital Pvt. Ltd.

Wadala, Mumbai, India, 400031

Status
Completed
 
Locations

Dr. Shroff's Charity Eye Hospital

New Delhi , India, 110002

Status
Completed
 
Locations

National University Hospital

Singapore, Singapore, 119074

Status
Completed
 
Locations

Paula Stradina Kliniskas Universitates slimnica

Riga, Latvia, 1002

Status
Completed
 
Locations

Singapore Eye Research Institution

Singapore, Singapore, 168751

Status
Completed
 

Trial Design