check_circleStudy Completed

Macular Degeneration

Bayer Identifier:

91689

ClinicalTrials.gov Identifier:

NCT00637377

EudraCT Number:

2007-000583-25

EU CT Number:

Not Available
Vascular endothelial growth factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)

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.

Key Participants Requirements

Sex

Both

Age

50 Years
  • - 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.
  • - 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
April 2008 - August 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Universitätsklinikum FreiburgFreiburg, 79106, Germany
Completed
St. Franziskus-Hospital GmbHMünster, 48145, Germany
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Completed
Klinikum rechts der IsarMünchen, 81675, Germany
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Completed
Universitätsklinikum AachenAachen, 52074, Germany
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20251, Germany
Completed
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Completed
Universitätsklinikum RegensburgRegensburg, 93053, Germany
Completed
Krankenhaus Dresden-FriedrichstadtDresden, 06067, Germany
Completed
Royal Liverpool University HospitalLiverpool, L7 8XP, United Kingdom
Completed
Kings College HospitalLondon, SE5 9RS, United Kingdom
Completed
Western Eye HospitalLondon, NW1 5QH, United Kingdom
Completed
Aberdeen Royal InfirmaryAberdeen, AB25 2ZN, United Kingdom
Completed
Queen's UniversityBelfast, BT12 6BA, United Kingdom
Completed
Plymouth Hospitals NHS Trust R&DPlymouth, PL4 6PL, United Kingdom
Completed
Aston UniversityBirmingham, B4 7ET, United Kingdom
Completed
Centre Hospitalier National d'Ophthalmologie Quinze-VingtParis, 75557, France
Completed
Centre Ophthalmologique RabelaisLyon, 69003, France
Completed
Universitätsklinikum KölnKöln, 50924, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
Universitätskliniken des SaarlandesHomburg, 66421, Germany
Completed
Klinikum DarmstadtDarmstadt, 64297, Germany
Completed
Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen, 67063, Germany
Completed
Southampton General HospitalSouthampton, SO16 6YD, United Kingdom
Completed
Torbay HospitalTorquay, TQ2 7AA, United Kingdom
Completed
Frimley Park Hospital NHSCamberley, GU16 5UJ, United Kingdom
Completed
Centre d'Ophtalmologie MonticelliMarseille, 13008, France
Completed
Hopital LariboisiereParis, 75010, France
Completed
Centre de Res en OphthalmologieLyon, 69006, France
Completed
C.H.U. PellegrinBordeaux, 33000, France
Completed
Hôpital Hôtel Dieu - Nantes CedexNantes, 44093, France
Completed
Centre hospitalier universitaire de BesanconBesancon, 25030, France
Completed
SMPK, SPSK im. Prof. W. OrlowskiegoWarszawa, 00-416, Poland
Completed
Centre Ophthalmologie d'Imagerie et de LaserParis, 75015, France
Completed
Centre Hospitalier Universitaire de DijonDijon, 21079, France
Completed
Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia ObrazenWarszaa, 02-005, Poland
Completed
Klinika OkulistykiWroclaw, 50-368, Poland
Completed
Gunma University HospitalMaebashi, 371-8511, Japan
Completed
Shiga University of Medical Science HospitalOtsu, 520-2192, Japan
Completed
Sapporo City General HospitalSapporo, 060-8604, Japan
Completed
Nagoya University HospitalNagoya, 466-8560, Japan
Completed
Kyoto University HospitalKyoto, 606-8507, Japan
Completed
Fukushima Medical University HospitalFukushima, 960-1295, Japan
Completed
Kagoshima University Medical and Dental HospitalKagoshima, 890-8520, Japan
Completed
Kagawa University HospitalKita, 761-0793, Japan
Completed
Osaka University HospitalSuita, 565-0871, Japan
Completed
ASL RM/A Roma - LazioRoma, 00198, Italy
Completed
A.O.U. Santa Maria Misericordia UDUdine, 33100, Italy
Completed
Szpiatal Kliniczny nr 1 Przemienienia PanskiegoPoznan, 61-848, Poland
Completed
Klinika Chorob OczuGdansk, 80-952, Poland
Completed
Okregowy Szpital KolejowyKatowice, 40-760, Poland
Completed
NZOZ "OFTALMIKA"Bydgoszcz, 85-631, Poland
Completed
Keio University HospitalShinjuku-ku, 160-8582, Japan
Completed
Nagoya City University HospitalNagoya, 467-8602, Japan
Completed
Juntendo University Urayasu HospitalUrayasu, 279-0021, Japan
Completed
Surugadai Nihon University HospitalChiyoda-ku, 101-8309, Japan
Completed
Kyushu University HospitalFukuoka, 812-8582, Japan
Completed
Kansai Medical University Hirakata HospitalHirakata, 573-1191, Japan
Completed
Università Cattolica del Sacro CuoreRoma, 00168, Italy
Completed
A.O.U. Policlinico ConsorzialeBari, 70124, Italy
Completed
IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca CancroGenova, 16132, Italy
Completed
A.O.U. Ospedali Riuniti Umberto I - Lancisi - SalesiAncona, 60126, Italy
Completed
A.O. Sacco Polo UniversitarioMilano, 20157, Italy
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
A.O. Osp Circolo e Fond.MacchiVarese, 21100, Italy
Terminated
Ospedale Maggiore Borgo TrentoVerona, 37121, Italy
Completed
Hospital Nuestra Senora de la EsperanzaSantiago de Compostela, 15705, Spain
Completed
Vissum Corporacion AlicanteAlicante, 03016, Spain
Completed
VISSUMMadrid, 28002, Spain
Completed
Instituto Oftalmológico de BarcelonaBarcelona, 08017, Spain
Completed
Hospital General de MalagaMalaga, 29010, Spain
Completed
Fundación Oftalmológica del MediterraneoValencia, 46015, Spain
Completed
Leids Universitair Medisch CentrumLeiden, 2333, Netherlands
Completed
Erasmus Medisch CentrumRotterdam, 3000 CA, Netherlands
Completed
Instituto de OftalmologíaMexico City, 06800, Mexico
Completed
Hospital Universitario "José Eleuterio González"Monterrey, 64480, Mexico
Terminated
Centro Medico ISSEMYMMetepec, 52140, Mexico
Completed
Fundacion Hospital Nuestra Señora de la LuzMexico City, 06030, Mexico
Completed
IRCCS Fond. Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
ASL TO/2 - PiemonteTorino, 10122, Italy
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
A.O.U. Policlinico - Vittorio EmanueleCatania, 95123, Italy
Completed
A.O.U. Policlinico Tor VergataRoma, 00133, Italy
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Hospital Universitario "La Paz"Madrid, 28046, Spain
Completed
Instituto Universitario de Oftalmobiología AplicadaValladolid, 47005, Spain
Completed
Hospital General Universitario de ValenciaValencia, 46014, Spain
Completed
Hospital Universitario Virgen de la MacarenaSevilla, 41009, Spain
Completed
Instituto Oftalmologico Fernandez VegaOviedo, 33012, Spain
Completed
Clínica Universitaria de NavarraPamplona, 31008, Spain
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Clínica PiñeroSevilla, 41013, Spain
Completed
Centro Medico TeknonBarcelona, 08022, Spain
Completed
Asociación para Evitar la Ceguera en México, I. A. P.México D.F., 04030, Mexico
Completed
St Eriks Eye HospitalStockholm, 11282, Sweden
Completed
Eye ClinicÖrebro, 70185, Sweden
Completed
Masaryk Hospital Usti n/LUsti nad Labem, 401 13, Czech Republic
Completed
Chaim Sheba Medical CenterTel Hashomer, Israel
Completed
Kaplan Medical CenterRehovot, 76100, Israel
Completed
Haemek Medical CenterAfula, Israel
Completed
Marsden Eye Surgery CenterParramatta, 2150, Australia
Completed
Royal Melbourne HospitalParkville, 3050, Australia
Completed
Save Sight InstituteSydney, 2000, Australia
Completed
Lion Eye InstituteNedlands, 6009, Australia
Completed
Eye Clinic Westmead HospitalWestmead, 2145, Australia
Completed
Oftalmólogos especialistasRosario, S2000ANJ, Argentina
Completed
Hospital Italiano Buenos AiresBuenos Aires, C1181ACH, Argentina
Completed
CHU de LiègeLiege, 4000, Belgium
Completed
University Medical Center St. RadboudNijmegen, 6525 EX, Netherlands
Terminated
Academic Medical Center Dept OphthalmologyAmsterdam, 1100 DD, Netherlands
Completed
Universitair Medisch Centrum GroningenGroningen, 9713 GZ, Netherlands
Completed
Hospital CIMA ChihuahuaChihuahua, 31238, Mexico
Completed
Centro Oftalmologico de GuadalajaraZapopan, 45060, Mexico
Completed
Centro Médico HidalgoMonterrey, 64060, Mexico
Completed
Eye ClinicLinköping, 58185, Sweden
Completed
Fakultni nemocnice BrnoBrno, 63400, Czech Republic
Completed
Vseobecna Fakultni Nemocnice OlomoucOlomouc, 77520, Czech Republic
Completed
Ocni klinika LexumPraha 4, 14000, Czech Republic
Completed
Fakultni nemocnice Kralovske VinohradyPraha 10, 10034, Czech Republic
Completed
Hebrew University - Hadassah Medical SchoolJerusalem, 91120, Israel
Completed
Tel-Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Organizacion Medica de Investigacion (OMI)Buenos Aires, C1015ABO, Argentina
Completed
Csolnoky Ferenc HospitalVeszprem, 8200, Hungary
Completed
Bajcsy Zsilinszky HospitalBudapest, 1106, Hungary
Completed
Budapest Retina AssociatesBudapest, 1133, Hungary
Completed
Clínica Oftalmológica San DiegoMedellín, Colombia
Completed
Fundación Oftalmológica NacionalBogota, Colombia
Completed
Instituto da VisaoMinas Gerais, 30150-270, Brazil
Completed
Hospital Israelita Albert EinsteinSão Paulo, 05651-901, Brazil
Completed
Seoul National University Bundang HospitalSeongnam, 463 707, Korea, Republic Of
Completed
Seoul St. Mary's HospitalSeoul, 137 701, Korea, Republic Of
Completed
Korea University Guro HospitalSeoul, 152-703, Korea, Republic Of
Completed
Universitätsspital ZürichZürich, 8091, Switzerland
Completed
Hôpital Cantonal Universitaire de GenèveGenève, 1211, Switzerland
Completed
Inselspital BernBern, 3010, Switzerland
Completed
L.V. Prasad Eye InstituteOrissa, 751 024, India
Completed
Rabin Medical CenterPetach Tikva, 49100, Israel
Completed
Assaf Harofeh Medical CenterZrifin, 70300, Israel
Completed
Meir Medical CenterKfar Saba, Israel
Completed
Soroka University Medical CenterBeer Sheva, Israel
Completed
Lady Davis Carmel Medical CenterHaifa, 34362, Israel
Completed
Centre for Eye ResearchEast Melbourne, 3002, Australia
Completed
Vision Eye InstituteChatswood, 2067, Australia
Completed
Hospital de Sao Joao - Centro Hospitalar de Sao Joao, EPEPorto, 4200-319, Portugal
Completed
AIBILI Azinhaga de SantaCoimbra, 3000-548, Portugal
Completed
Praxis Dr. Domingo TaciteCórdoba, X5000IIT, Argentina
Completed
Fundación ZambranoBuenos Aires, C1023AAQ, Argentina
Completed
Instituto de la Visión S.A.Buenos Aires, C1122AAI, Argentina
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Konventhospital Barmherzige Brüder LinzLinz, 4021, Austria
Completed
Dr.R.P. Center for Ophthalmic SciencesNew Delhi, 110029, India
Completed
Post Graduate Institute of Medical Education and ResearchChandigarh, 160012, India
Completed
Aravind Eye HospitalMadurai, 625 020, India
Completed
Aravind Eye HospitalCoimbatore, 641014, India
Completed
Retina FoundationAhemedabad - 4, 380009, India
Completed
Shroff Eye HospitalMumbai, 400 050, India
Completed
Alexandra HospitalSingapore, 159964, Singapore
Completed
Tan Tock Seng HospitalSingapore, 308433, Singapore
Terminated
Dr. Solomatins EyeRiga, 1050, Latvia
Completed
Latvijas-Amerikas acu centrsRiga, 1009, Latvia
Completed
University of SemmelweisBudapest, 1083, Hungary
Completed
Clínica Oftalmológica de CaliCali, Colombia
Completed
Instituto Nacional de Investigación en OftalmologíaMedellín, Colombia
Completed
Hosp Clínicas Facult. Med. de Ribeirão Preto / USPRibeirão Preto, 14048-900, Brazil
Completed
Hospital Sao Paulo - UNIFESPSao Paulo, 04023-062, Brazil
Completed
Faculty Hospital F. D. RooseveltBanska Bystrica, 97517, Slovakia
Completed
Univerzitná nemocnica Bratislava, Nemocnica Stare MestoBratislava, 81369, Slovakia
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110 744, Korea, Republic Of
Completed
Gachon University Gil Medical CenterIncheon, 405-760, Korea, Republic Of
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Regional Institute of OphthalmologyKolkata, 700073, India
Completed
L.V. Prasad Eye InstituteHyderabad, 500 034, India
Completed
Narayana NetralayaBangalore, 560010, India
Completed
Shankar NetralayaChennai, 600 006, India
Completed
Little Flower HospitalKerala, 683572, India
Completed
Aravind Eye HospitalPondicherry, 600007, India
Completed
Aditya Jyot Eye Hospital Pvt. Ltd.Wadala, Mumbai, 400031, India
Completed
Dr. Shroff's Charity Eye HospitalNew Delhi, 110002, India
Completed
National University HospitalSingapore, 119074, Singapore
Completed
Paula Stradina Kliniskas Universitates slimnicaRiga, 1002, Latvia
Completed
Singapore Eye Research InstitutionSingapore, 168751, Singapore

Primary Outcome

  • Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
    date_rangeTime Frame:
    At week 52
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF
    date_rangeTime Frame:
    Baseline and at week 52
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF
    date_rangeTime Frame:
    At week 52
    enhanced_encryption
    Safety Issue:
    No
  • Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF
    date_rangeTime Frame:
    Baseline and at week 52
    enhanced_encryption
    Safety Issue:
    No
  • Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF
    date_rangeTime Frame:
    Baseline and at week 52
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to view the data of the twin trial conducted by the collaboration partner.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe