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

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
Status
LocationsStatus
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Universitätsklinikum Freiburg

Freiburg, Germany, 79106

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

Klinikum Darmstadt

Darmstadt, Germany, 64297

Status
Completed
 
Locations

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany, 67063

Status
Completed
 
Locations

Universitätsklinikum Aachen

Aachen, Germany, 52074

Status
Completed
 
Locations

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 09116

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Terminated
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20251

Status
Completed
 
Locations

Universitätskliniken des Saarlandes

Homburg, Germany, 66421

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Terminated
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50924

Status
Completed
 
Locations

Krankenhaus Dresden-Friedrichstadt

Dresden, Germany, 06067

Status
Completed
 
Locations

Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Germany, 37075

Status
Completed
 
Locations

Universitätsklinikum Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

Centre Ophthalmologie d'Imagerie et de Laser

Paris, France, 75015

Status
Completed
 
Locations

Nagoya University Hospital

Nagoya, Japan, 466-8560

Status
Completed
 
Locations

Kyoto University Hospital

Kyoto, Japan, 606-8507

Status
Completed
 
Locations

A.O.U. Policlinico Consorziale

Bari, Italy, 70124

Status
Completed
 
Locations

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

Ancona, Italy, 60126

Status
Completed
 
Locations

ASL RM/A Roma - Lazio

Roma, Italy, 00198

Status
Completed
 
Locations

Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35037

Status
Completed
 
Locations

C.H.U. Pellegrin

Bordeaux, France, 33000

Status
Completed
 
Locations

Centre d'Ophtalmologie - Paradis-Monticelli

MARSEILLE, France, 13008

Status
Completed
 
Locations

Centre Hospitalier National d'Ophthalmologie Quinze-Vingt

Paris, France, 75557

Status
Terminated
 
Locations

Hôpital Hôtel Dieu - Nantes Cedex

Nantes, France, 44093

Status
Completed
 
Locations

Centre Hospitalier Universitaire de Dijon

Dijon, France, 21033

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

Osaka University Hospital

Suita, Japan, 565-0871

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

A.O.U. Policlinico Tor Vergata

Roma, Italy, 00133

Status
Completed
 
Locations

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

A.O.U. Policlinico

Catania, Italy, 95123

Status
Terminated
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Terminated
 
Locations

A.O. Sacco Polo Universitario

Milano, Italy, 20157

Status
Terminated
 
Locations

ASL TO/2 - Piemonte

Torino, Italy, 10122

Status
Terminated
 
Locations

Lion Eye Institute

Nedlands, Australia, 6009

Status
Completed
 
Locations

Vision Eye Institute

Chatswood, Australia, 2067

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

University of Semmelweis

Budapest, Hungary, 1089

Status
Completed
 
Locations

Bajcsy Zsilinszky Hospital

Budapest, Hungary, 1106

Status
Completed
 
Locations

University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Seoul St. Mary's Hospital

Seoul, South Korea, 137-701

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110 744

Status
Completed
 
Locations

Yonsei University College of Medicine

Seoul, South Korea

Status
Completed
 
Locations

National University Hospital

Singapore, Singapore, 119074

Status
Completed
 
Locations

Latvijas-Amerikas acu centrs

Riga, Latvia, 1050

Status
Completed
 
Locations

Paula Stradina Kliniskas Universitates slimnica

Riga, Latvia, 1002

Status
Completed
 
Locations

Save Sight Institute

Sydney, Australia, 2000

Status
Completed
 
Locations

Marsden Eye Surgery Center

Parramatta, Australia, 2150

Status
Completed
 
Locations

Westmead Hospital

Westmead, Australia, 2145

Status
Completed
 
Locations

Centre for Eye Research

East Melbourne, Australia, 3002

Status
Completed
 
Locations

Konventhospital Barmherzige Brüder Linz

Linz, Austria, 4021

Status
Completed
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Terminated
 
Locations

A.ö. Krankenhaus der Stadt Linz

Linz, Austria, 4021

Status
Completed
 
Locations

Csolnoky Ferenc Hospital

Veszprem, Hungary, 8200

Status
Terminated
 
Locations

Budapest Retina Associates

Budapest, Hungary, 1133

Status
Completed
 
Locations

Zala Megyei Korhaz

Zalaegerszeg, Hungary, H-8900

Status
Completed
 
Locations

Gachon University Gil Medical Center

Incheon , South Korea, 405-760

Status
Completed
 
Locations

Seoul National Univ. Bundang Hospital

Seongnam-si, South Korea, 463-707

Status
Completed
 
Locations

Singapore National Eye Centre

Singapore, Singapore, 168751

Status
Completed
 
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Terminated
 
Locations

St. Franziskus-Hospital GmbH

Münster, Germany, 48145

Status
Terminated
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60596

Status
Completed
 

Trial Design