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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Freiburg Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum rechts der Isar München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Schleswig-Holstein / AÖR Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Darmstadt Darmstadt, Germany, 64297 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen, Germany, 67063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Aachen Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Chemnitz gGmbH Chemnitz, Germany, 09116 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20251 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätskliniken des Saarlandes Homburg, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Christian-Albrechts-Universität Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Köln Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Dresden-Friedrichstadt Dresden, Germany, 06067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsmedizin der Georg-August-Universität Göttingen Göttingen, Germany, 37075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Regensburg Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Ophthalmologie d'Imagerie et de Laser Paris, France, 75015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto University Hospital Kyoto, Japan, 606-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Consorziale Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi Ancona, Italy, 60126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL RM/A Roma - Lazio Roma, Italy, 00198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinik Gießen und Marburg GmbH Marburg, Germany, 35037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations C.H.U. Pellegrin Bordeaux, France, 33000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'Ophtalmologie - Paradis-Monticelli MARSEILLE, France, 13008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier National d'Ophthalmologie Quinze-Vingt Paris, France, 75557 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Hôtel Dieu - Nantes Cedex Nantes, France, 44093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire de Dijon Dijon, France, 21033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagoya City University Hospital Nagoya, Japan, 467-8602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Juntendo University Urayasu Hospital Urayasu, Japan, 279-0021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Surugadai Nihon University Hospital Chiyoda-ku, Japan, 101-8309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka University Hospital Suita, Japan, 565-0871 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Tor Vergata Roma, Italy, 00133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Catania, Italy, 95123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sacco Polo Universitario Milano, Italy, 20157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL TO/2 - Piemonte Torino, Italy, 10122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lion Eye Institute Nedlands, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vision Eye Institute Chatswood, Australia, 2067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Semmelweis Budapest, Hungary, 1089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bajcsy Zsilinszky Hospital Budapest, Hungary, 1106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Debrecen Medical&Health Science Center Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul St. Mary's Hospital Seoul, South Korea, 137-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110 744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yonsei University College of Medicine Seoul, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National University Hospital Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Latvijas-Amerikas acu centrs Riga, Latvia, 1050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Paula Stradina Kliniskas Universitates slimnica Riga, Latvia, 1002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Save Sight Institute Sydney, Australia, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marsden Eye Surgery Center Parramatta, Australia, 2150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Westmead Hospital Westmead, Australia, 2145 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre for Eye Research East Melbourne, Australia, 3002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Konventhospital Barmherzige Brüder Linz Linz, Austria, 4021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.ö. Krankenhaus der Stadt Linz Linz, Austria, 4021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Csolnoky Ferenc Hospital Veszprem, Hungary, 8200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Budapest Retina Associates Budapest, Hungary, 1133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zala Megyei Korhaz Zalaegerszeg, Hungary, H-8900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gachon University Gil Medical Center Incheon , South Korea, 405-760 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National Univ. Bundang Hospital Seongnam-si, South Korea, 463-707 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Singapore National Eye Centre Singapore, Singapore, 168751 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Franziskus-Hospital GmbH Münster, Germany, 48145 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-masked, sham-controlled phase 3 study of the efficacy, safety and tolerability of repeated intravitreal administration of VEGF Trap-Eye in subjects with macular edema secondary to central retinal vein occlusion (CRVO)
Trial Type:
Interventional
Intervention Type:
Biological/Vaccine
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Percentage of participants who gained at least 15 letters in BCVA as measured by ETDRS letter score compared with baseline at Week 24 with discontinued participants before Week 24 evaluated as failuresTimeframe: Baseline and Week 24
Secondary Outcome
- Change from baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 24 - Last observation carried forward (LOCF)Timeframe: Baseline and Week 24
- Change from baseline in Central Retinal Thickness (CRT) at Week 24 - LOCFTimeframe: Baseline and Week 24
- Percentage of participants who developed Neovascularization during the first 24 weeksTimeframe: From baseline until Week 24
- Change from baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score at Week 24 - LOCFTimeframe: Baseline and Week 24
- Change from baseline in European five-dimensional health scale (EQ-5D) score at Week 24 - LOCFTimeframe: Baseline and Week 24
Additional Information
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