Trial Condition(s):

Retinal Vein Occlusion

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) (GALILEO)

Bayer Identifier:

14130

ClinicalTrials.gov Identifier:

NCT01012973

EudraCT Number:

2009-010973-19

EU CT Number:

Not Available

Study Completed

Trial Purpose

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

Inclusion Criteria
- Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical coherence tomography (OCT)
 - Adults ≥ 18 years
 - Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye
Exclusion Criteria
- Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
 - Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
 - CRVO disease duration > 9 months from date of diagnosis
 - Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
 - Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Trial Summary

Enrollment Goal
177
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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Klinikum rechts der Isar

München, Germany, 81675

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Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

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Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

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Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

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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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Universitätsklinikum Aachen

Aachen, Germany, 52074

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Klinikum Chemnitz gGmbH

Chemnitz, Germany, 09116

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Universitätsklinikum Essen

Essen, Germany, 45122

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Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20251

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Universitätskliniken des Saarlandes

Homburg, Germany, 66421

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Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

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Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

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Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

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Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

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Universitätsklinikum Köln

Köln, Germany, 50924

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Krankenhaus Dresden-Friedrichstadt

Dresden, Germany, 06067

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Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Germany, 37075

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Universitätsklinikum Regensburg

Regensburg, Germany, 93053

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Centre Ophthalmologie d'Imagerie et de Laser

Paris, France, 75015

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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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A.O.U. Policlinico Consorziale

Bari, Italy, 70124

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

Ancona, Italy, 60126

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ASL RM/A Roma - Lazio

Roma, Italy, 00198

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Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35037

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C.H.U. Pellegrin

Bordeaux, France, 33000

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Centre d'Ophtalmologie - Paradis-Monticelli

MARSEILLE, France, 13008

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Centre Hospitalier National d'Ophthalmologie Quinze-Vingt

Paris, France, 75557

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Hôpital Hôtel Dieu - Nantes Cedex

Nantes, France, 44093

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Centre Hospitalier Universitaire de Dijon

Dijon, France, 21033

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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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Osaka University Hospital

Suita, Japan, 565-0871

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A.O.U. Careggi

Firenze, Italy, 50134

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A.O.U. Policlinico Tor Vergata

Roma, Italy, 00133

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IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

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IRCCS Fondazione San Raffaele

Milano, Italy, 20132

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A.O.U. Policlinico

Catania, Italy, 95123

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A.O. di Padova

Padova, Italy, 35128

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A.O. Sacco Polo Universitario

Milano, Italy, 20157

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ASL TO/2 - Piemonte

Torino, Italy, 10122

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Lion Eye Institute

Nedlands, Australia, 6009

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Vision Eye Institute

Chatswood, Australia, 2067

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Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

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University of Semmelweis

Budapest, Hungary, 1089

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Bajcsy Zsilinszky Hospital

Budapest, Hungary, 1106

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University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4032

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Asan Medical Center

Seoul, South Korea, 138-736

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Seoul St. Mary's Hospital

Seoul, South Korea, 137-701

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Seoul National University Hospital

Seoul, South Korea, 110 744

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Yonsei University College of Medicine

Seoul, South Korea

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National University Hospital

Singapore, Singapore, 119074

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Latvijas-Amerikas acu centrs

Riga, Latvia, 1050

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Paula Stradina Kliniskas Universitates slimnica

Riga, Latvia, 1002

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Save Sight Institute

Sydney, Australia, 2000

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Marsden Eye Surgery Center

Parramatta, Australia, 2150

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Westmead Hospital

Westmead, Australia, 2145

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Centre for Eye Research

East Melbourne, Australia, 3002

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Konventhospital Barmherzige Brüder Linz

Linz, Austria, 4021

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Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

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A.ö. Krankenhaus der Stadt Linz

Linz, Austria, 4021

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Csolnoky Ferenc Hospital

Veszprem, Hungary, 8200

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Budapest Retina Associates

Budapest, Hungary, 1133

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Zala Megyei Korhaz

Zalaegerszeg, Hungary, H-8900

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Gachon University Gil Medical Center

Incheon , South Korea, 405-760

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Seoul National Univ. Bundang Hospital

Seongnam-si, South Korea, 463-707

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Singapore National Eye Centre

Singapore, Singapore, 168751

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Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

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St. Franziskus-Hospital GmbH

Münster, Germany, 48145

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Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60596

Trial Design