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

EU CT Number:

Not Available

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

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Locations
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Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

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Universitätsklinikum Freiburg

Freiburg, Germany, 79106

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St. Franziskus-Hospital GmbH

Münster, Germany, 48145

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Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

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Charité Campus Benjamin Franklin

Berlin, Germany, 12200

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Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

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Klinikum rechts der Isar

München, Germany, 81675

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Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

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Universitätsklinikum Aachen

Aachen, Germany, 52074

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Universitätsklinikum Essen

Essen, Germany, 45122

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Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

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Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

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Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20251

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Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

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Universitätsklinikum Regensburg

Regensburg, Germany, 93053

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Krankenhaus Dresden-Friedrichstadt

Dresden, Germany, 06067

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Royal Liverpool University Hospital

Liverpool, United Kingdom, L7 8XP

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Kings College Hospital

London, United Kingdom, SE5 9RS

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Western Eye Hospital

London, United Kingdom, NW1 5QH

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Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

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Queen's University

Belfast, United Kingdom, BT12 6BA

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Plymouth Hospitals NHS Trust R&D

Plymouth, United Kingdom, PL4 6PL

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Aston University

Birmingham, United Kingdom, B4 7ET

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Centre Hospitalier National d'Ophthalmologie Quinze-Vingt

Paris, France, 75557

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Centre Ophthalmologique Rabelais

Lyon, France, 69003

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Universitätsklinikum Köln

Köln, Germany, 50924

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Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

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Universitätskliniken des Saarlandes

Homburg, Germany, 66421

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Klinikum Darmstadt

Darmstadt, Germany, 64297

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Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany, 67063

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Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

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Torbay Hospital

Torquay, United Kingdom, TQ2 7AA

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Frimley Park Hospital NHS

Camberley, United Kingdom, GU16 5UJ

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Centre d'Ophtalmologie Monticelli

Marseille, France, 13008

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Hopital Lariboisiere

Paris, France, 75010

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Centre de Res en Ophthalmologie

Lyon, France, 69006

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C.H.U. Pellegrin

Bordeaux, France, 33000

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Hôpital Hôtel Dieu - Nantes Cedex

Nantes, France, 44093

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Centre hospitalier universitaire de Besancon

Besancon, France, 25030

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SMPK, SPSK im. Prof. W. Orlowskiego

Warszawa, Poland, 00-416

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Centre Ophthalmologie d'Imagerie et de Laser

Paris, France, 75015

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Centre Hospitalier Universitaire de Dijon

Dijon, France, 21079

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Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen

Warszaa, Poland, 02-005

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Klinika Okulistyki

Wroclaw, Poland, 50-368

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Gunma University Hospital

Maebashi, Japan, 371-8511

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Shiga University of Medical Science Hospital

Otsu, Japan, 520-2192

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Sapporo City General Hospital

Sapporo, Japan, 060-8604

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Nagoya University Hospital

Nagoya, Japan, 466-8560

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Kyoto University Hospital

Kyoto, Japan, 606-8507

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Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

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Kagoshima University Medical and Dental Hospital

Kagoshima, Japan, 890-8520

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Kagawa University Hospital

Kita, Japan, 761-0793

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Osaka University Hospital

Suita, Japan, 565-0871

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ASL RM/A Roma - Lazio

Roma, Italy, 00198

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A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

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Szpiatal Kliniczny nr 1 Przemienienia Panskiego

Poznan, Poland, 61-848

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Klinika Chorob Oczu

Gdansk, Poland, 80-952

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Okregowy Szpital Kolejowy

Katowice, Poland, 40-760

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NZOZ "OFTALMIKA"

Bydgoszcz, Poland, 85-631

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Keio University Hospital

Shinjuku-ku, Japan, 160-8582

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Nagoya City University Hospital

Nagoya, Japan, 467-8602

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Juntendo University Urayasu Hospital

Urayasu, Japan, 279-0021

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Surugadai Nihon University Hospital

Chiyoda-ku, Japan, 101-8309

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Kyushu University Hospital

Fukuoka, Japan, 812-8582

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Kansai Medical University Hirakata Hospital

Hirakata, Japan, 573-1191

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Università Cattolica del Sacro Cuore

Roma, Italy, 00168

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A.O.U. Policlinico Consorziale

Bari, Italy, 70124

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

Genova, Italy, 16132

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

Ancona, Italy, 60126

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A.O. Sacco Polo Universitario

Milano, Italy, 20157

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A.O. di Padova

Padova, Italy, 35128

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A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

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Ospedale Maggiore Borgo Trento

Verona, Italy, 37121

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Hospital Nuestra Senora de la Esperanza

Santiago de Compostela, Spain, 15705

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Vissum Corporacion Alicante

Alicante, Spain, 03016

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VISSUM

Madrid, Spain, 28002

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Instituto Oftalmológico de Barcelona

Barcelona, Spain, 08017

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Hospital General de Malaga

Malaga, Spain, 29010

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Fundación Oftalmológica del Mediterraneo

Valencia, Spain, 46015

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Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333

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Erasmus Medisch Centrum

Rotterdam, Netherlands, 3000 CA

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Instituto de Oftalmología

Mexico City, Mexico, 06800

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Hospital Universitario "José Eleuterio González"

Monterrey, Mexico, 64480

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Centro Medico ISSEMYM

Metepec, Mexico, 52140

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Fundacion Hospital Nuestra Señora de la Luz

Mexico City, Mexico, 06030

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IRCCS Fond. Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

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ASL TO/2 - Piemonte

Torino, Italy, 10122

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IRCCS Fondazione San Raffaele

Milano, Italy, 20132

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A.O.U. Policlinico - Vittorio Emanuele

Catania, Italy, 95123

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A.O.U. Policlinico Tor Vergata

Roma, Italy, 00133

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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

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Hospital Universitario "La Paz"

Madrid, Spain, 28046

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Instituto Universitario de Oftalmobiología Aplicada

Valladolid, Spain, 47005

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Hospital General Universitario de Valencia

Valencia, Spain, 46014

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Hospital Universitario Virgen de la Macarena

Sevilla, Spain, 41009

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Instituto Oftalmologico Fernandez Vega

Oviedo, Spain, 33012

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Clínica Universitaria de Navarra

Pamplona, Spain, 31008

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Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

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Clínica Piñero

Sevilla, Spain, 41013

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Centro Medico Teknon

Barcelona, Spain, 08022

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

México D.F., Mexico, 04030

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St Eriks Eye Hospital

Stockholm, Sweden, 11282

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Eye Clinic

Örebro, Sweden, 70185

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Masaryk Hospital Usti n/L

Usti nad Labem, Czech Republic, 401 13

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Chaim Sheba Medical Center

Tel Hashomer, Israel

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Kaplan Medical Center

Rehovot, Israel, 76100

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Haemek Medical Center

Afula, Israel

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Marsden Eye Surgery Center

Parramatta, Australia, 2150

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Royal Melbourne Hospital

Parkville, Australia, 3050

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Save Sight Institute

Sydney, Australia, 2000

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Lion Eye Institute

Nedlands, Australia, 6009

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Eye Clinic Westmead Hospital

Westmead, Australia, 2145

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Oftalmólogos especialistas

Rosario, Argentina, S2000ANJ

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Hospital Italiano Buenos Aires

Buenos Aires, Argentina, C1181ACH

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CHU de Liège

Liege, Belgium, 4000

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University Medical Center St. Radboud

Nijmegen, Netherlands, 6525 EX

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Academic Medical Center Dept Ophthalmology

Amsterdam, Netherlands, 1100 DD

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Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

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Hospital CIMA Chihuahua

Chihuahua, Mexico, 31238

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Centro Oftalmologico de Guadalajara

Zapopan, Mexico, 45060

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Centro Médico Hidalgo

Monterrey, Mexico, 64060

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Eye Clinic

Linköping, Sweden, 58185

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Fakultni nemocnice Brno

Brno, Czech Republic, 63400

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Vseobecna Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 77520

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Ocni klinika Lexum

Praha 4, Czech Republic, 14000

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Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 10034

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Hebrew University - Hadassah Medical School

Jerusalem, Israel, 91120

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Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

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Organizacion Medica de Investigacion (OMI)

Buenos Aires, Argentina, C1015ABO

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Csolnoky Ferenc Hospital

Veszprem, Hungary, 8200

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Bajcsy Zsilinszky Hospital

Budapest, Hungary, 1106

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Budapest Retina Associates

Budapest, Hungary, 1133

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Clínica Oftalmológica San Diego

Medellín, Colombia

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Fundación Oftalmológica Nacional

Bogota, Colombia

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Instituto da Visao

Minas Gerais, Brazil, 30150-270

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Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-901

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Seoul National University Bundang Hospital

Seongnam, South Korea, 463 707

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Seoul St. Mary's Hospital

Seoul, South Korea, 137 701

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Korea University Guro Hospital

Seoul , South Korea, 152-703

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Universitätsspital Zürich

Zürich, Switzerland, 8091

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Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1211

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Inselspital Bern

Bern, Switzerland, 3010

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L.V. Prasad Eye Institute

Orissa, India, 751 024

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Rabin Medical Center

Petach Tikva, Israel, 49100

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Assaf Harofeh Medical Center

Zrifin, Israel, 70300

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Meir Medical Center

Kfar Saba, Israel

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Soroka University Medical Center

Beer Sheva, Israel

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Lady Davis Carmel Medical Center

Haifa, Israel, 34362

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Centre for Eye Research

East Melbourne, Australia, 3002

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Vision Eye Institute

Chatswood, Australia, 2067

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

Porto, Portugal, 4200-319

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AIBILI Azinhaga de Santa

Coimbra, Portugal, 3000-548

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Praxis Dr. Domingo Tacite

Córdoba, Argentina, X5000IIT

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Fundación Zambrano

Buenos Aires, Argentina, C1023AAQ

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Instituto de la Visión S.A.

Buenos Aires, Argentina, C1122AAI

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Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

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Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

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Konventhospital Barmherzige Brüder Linz

Linz, Austria, 4021

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Dr.R.P. Center for Ophthalmic Sciences

New Delhi, India, 110029

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Post Graduate Institute of Medical Education and Research

Chandigarh, India, 160012

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Aravind Eye Hospital

Madurai, India, 625 020

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Aravind Eye Hospital

Coimbatore, India, 641014

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Retina Foundation

Ahemedabad - 4, India, 380009

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Shroff Eye Hospital

Mumbai, India, 400 050

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Alexandra Hospital

Singapore, Singapore, 159964

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Tan Tock Seng Hospital

Singapore, Singapore, 308433

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Dr. Solomatins Eye

Riga, Latvia, 1050

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Latvijas-Amerikas acu centrs

Riga, Latvia, 1009

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University of Semmelweis

Budapest, Hungary, 1083

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Clínica Oftalmológica de Cali

Cali, Colombia

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Instituto Nacional de Investigación en Oftalmología

Medellín, Colombia

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Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

Ribeirão Preto, Brazil, 14048-900

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Hospital Sao Paulo - UNIFESP

Sao Paulo, Brazil, 04023-062

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Faculty Hospital F. D. Roosevelt

Banska Bystrica, Slovakia, 97517

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Univerzitná nemocnica Bratislava, Nemocnica Stare Mesto

Bratislava, Slovakia, 81369

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Asan Medical Center

Seoul, South Korea, 138-736

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Seoul National University Hospital

Seoul, South Korea, 110 744

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Gachon University Gil Medical Center

Incheon, South Korea, 405-760

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Universitätsspital Basel

Basel, Switzerland, 4031

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Regional Institute of Ophthalmology

Kolkata, India, 700073

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L.V. Prasad Eye Institute

Hyderabad, India, 500 034

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Narayana Netralaya

Bangalore, India, 560010

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Shankar Netralaya

Chennai, India, 600 006

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Little Flower Hospital

Kerala, India, 683572

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Aravind Eye Hospital

Pondicherry, India, 600007

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Aditya Jyot Eye Hospital Pvt. Ltd.

Wadala, Mumbai, India, 400031

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Dr. Shroff's Charity Eye Hospital

New Delhi , India, 110002

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National University Hospital

Singapore, Singapore, 119074

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Paula Stradina Kliniskas Universitates slimnica

Riga, Latvia, 1002

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Singapore Eye Research Institution

Singapore, Singapore, 168751

Trial Design