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`History of Changes for Study: NCT01012973
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`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal
`Vein Occlusion (CRVO)
`
`Latest version (submitted October 27, 2014) on ClinicalTrials.gov
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`A study version is represented by a row in the table.
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`Select two study versions to compare. One each from columns A and B.
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`Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
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`Click "Compare" to do the comparison and show the differences.
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`Select a version's Submitted Date link to see a rendering of the study for that version.
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`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
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`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
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`Study edits or deletions are displayed in red.
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`Study additions are displayed in green .
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`Study Record Versions
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`November 12, 2009 None (earliest Version on record)
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`January 21, 2010 Contacts/Locations, Study Status, Study Identification and Study Description
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`History of Changes for Study: NCT01012973
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`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal
`Vein Occlusion (CRVO)
`
`Latest version (submitted October 27, 2014) on ClinicalTrials.gov
`
`A study version is represented by a row in the table.
`
`Select two study versions to compare. One each from columns A and B.
`
`Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
`
`Click "Compare" to do the comparison and show the differences.
`
`Select a version's Submitted Date link to see a rendering of the study for that version.
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`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
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`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
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`Study edits or deletions are displayed in red.
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`Study additions are displayed in green .
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`Study Record Versions
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`Version
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`November 12, 2009 None (earliest Version on record)
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`January 21, 2010 Contacts/Locations, Study Status, Study Identification and Study Description
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`April 16, 2010 Contacts/Locations, Study Status and Study Identification
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`July 22, 2010 Contacts/Locations, Study Status, Eligibility and Arms and Interventions
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`August 25, 2010 Study Status and Contacts/Locations
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`August 26, 2010 Recruitment Status, Study Status and Contacts/Locations
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`September 8, 2010 Study Status
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`October 4, 2010 Study Status
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`November 1, 2010 Study Status
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`January 25, 2011 Study Status and Contacts/Locations
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`April 8, 2011 Study Status and Study Design
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`June 23, 2011 Arms and Interventions, Study Status, Contacts/Locations and Eligibility
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`September 19, 2011 Study Status
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`November 29, 2011 Study Status and Study Identification
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`January 26, 2012 Study Status and Contacts/Locations
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`February 20, 2012 Recruitment Status and Study Status
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`October 23, 2012 Outcome Measures, Arms and Interventions, Study Status, More Information, Reported Adverse Events,
`Baseline Characteristics and Participant Flow
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`December 18, 2012 Arms and Interventions, Study Status and Baseline Characteristics
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`January 30, 2014 Contacts/Locations, Sponsor/Collaborators, Study Status, Baseline Characteristics and References
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`October 27, 2014 Study Status and References
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`Compare
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`Study NCT01012973
`Submitted Date: November 12, 2009 (v1)
`
`Study Identification
`Unique Protocol ID: 14130
`Brief Title: Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central
`Retinal Vein Occlusion (CRVO)
`Official Title: 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)
`Secondary IDs: EudraCT: 2009-010973-19
`GALILEO
`
`Study Status
`
`Record Verification: November 2009
`Overall Status: Recruiting
`Study Start: October 2009
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`Primary Completion: February 2011 [Anticipated]
`Study Completion: August 2012 [Anticipated]
`
`First Submitted: October 30, 2009
`First Submitted that
`November 12, 2009
`Met QC Criteria:
`First Posted: November 13, 2009 [Estimate]
`
`November 12, 2009
`
`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: November 13, 2009 [Estimate]
`Sponsor/Collaborators
`
`Sponsor: Bayer
`Responsible Party:
`Collaborators: Regeneron Pharmaceuticals
`
`Oversight
`U.S. FDA-regulated Drug:
`U.S. FDA-regulated Device:
`Data Monitoring: Yes
`Study Description
`Brief Summary: 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.
`
`Detailed Description:
`
`Conditions
`
`Conditions: Retinal Vein Occlusion
`Keywords: Macular Edema
`Central Retinal Vein Occlusion
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`CRVO
`VEGF Trap-Eye
`best-corrected visual acuity
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`Study Design
`
`Study Type: Interventional
`Primary Purpose: Treatment
`Study Phase: Phase 3
`Interventional Study Model: Parallel Assignment
`Number of Arms: 2
`Masking: Triple (Participant, Investigator, Outcomes Assessor)
`Allocation: Randomized
`Enrollment: 165 [Anticipated]
`Arms and Interventions
`
`Experimental: Arm 1
`
`Arms
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`Sham Comparator: Arm 2
`
`Assigned Interventions
`Drug: VEGF Trap-Eye (BAY86-5321)
`Intravitreal injection. Weeks 0 to 20 injection of VEGF Trap-
`Eye every 4 weeks; weeks 24 to 48 every 4 weeks re-
`assessment and either (PRN) injection of VEGF Trap-Eye or
`sham injection; weeks 52 to 100 safety follow-up.
`
`Sham treatment
`Sham treatment. Weeks 0 to 20 sham treatment every 4
`weeks; weeks 24 to 48 every 4 weeks re-assessment and
`sham injection; weeks 52 to 100 safety follow-up.
`
`Outcome Measures
`Primary Outcome Measures:
`1. The proportion of subjects who gain at least 15 letters in BCVA on the EDTRS chart compared with baseline at the Week 24
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`endpoint
`Week 24
`Secondary Outcome Measures:
`2. Change from baseline in BCVA score
`Week 24
`3. Absolute change from baseline in central retinal thickness, assessed by OCT
`Week 24
`4. Proportion of subjects progressing to anterior segment neovascularization, neovascularization of the optic disc (NVD), or
`neovascularization of the retina elsewhere (NVE) requiring pan-retinal photocoagulation
`Week 24
`5. Change in the NEI-VFQ-25 total score from baseline
`Week 24
`6. Change in the EQ-5D score from baseline
`Week 24
`
`Eligibility
`
`Minimum Age: 18 Years
`Maximum Age:
`Sex: All
`Gender Based:
`Accepts Healthy Volunteers: No
`Criteria: 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.
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`Exclusion Criteria:
`
`Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium, anecortave
`acetate, bevacizumab, ranibizumab, etc.)
`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
`
`Contacts/Locations
`Central Contact: Bayer Clinical Trials Contact
`Email: clinical-trials-contact@bayerhealthcare.com
`Study Officials: Bayer Study Director
`Study Director
`Bayer
`Locations: Australia, New South Wales
`[Not yet recruiting]
`Chatswood, New South Wales, Australia, 2067
`[Not yet recruiting]
`Sydney, New South Wales, Australia, 2000
`[Not yet recruiting]
`Sydney, New South Wales, Australia, 2145
`Australia, Victoria
`[Not yet recruiting]
`East Melbourne, Victoria, Australia, 3002
`Australia, Western Australia
`[Not yet recruiting]
`Nedlands, Western Australia, Australia, 6009
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`Australia
`[Not yet recruiting]
`Parramatta, Australia, 2150
`Austria, Oberösterreich
`[Not yet recruiting]
`Linz, Oberösterreich, Austria, 4020
`Austria, Tirol
`[Not yet recruiting]
`Innsbruck, Tirol, Austria, 6020
`Austria
`[Not yet recruiting]
`Linz, Austria, 4021
`[Not yet recruiting]
`Wien, Austria, 1090
`France, Cedex 12
`[Not yet recruiting]
`Paris, Cedex 12, France, 75557
`France
`[Not yet recruiting]
`Bordeaux, France, 33000
`[Not yet recruiting]
`Dijon Cedex, France, BP 1542-21
`[Not yet recruiting]
`Marseille, France, 13008
`[Not yet recruiting]
`Nantes Cedex, France, 44035
`[Not yet recruiting]
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`Paris, France, 75015
`Germany, Baden-Württemberg
`[Not yet recruiting]
`Freiburg, Baden-Württemberg, Germany, 79106
`[Not yet recruiting]
`Heidelberg, Baden-Württemberg, Germany, 69120
`[Not yet recruiting]
`Tübingen, Baden-Württemberg, Germany, 72076
`Germany, Bayern
`[Not yet recruiting]
`München, Bayern, Germany, 81675
`[Not yet recruiting]
`Regensburg, Bayern, Germany, 93053
`Germany, Hessen
`[Recruiting]
`Darmstadt, Hessen, Germany, 64276
`[Not yet recruiting]
`Marburg, Hessen, Germany, 35043
`Germany, Niedersachsen
`[Not yet recruiting]
`Göttingen, Niedersachsen, Germany, 37075
`Germany, Nordrhein-Westfalen
`[Not yet recruiting]
`Aachen, Nordrhein-Westfalen, Germany, 52074
`[Not yet recruiting]
`Bonn, Nordrhein-Westfalen, Germany, 53105
`[Not yet recruiting]
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`Essen, Nordrhein-Westfalen, Germany, 45147
`[Not yet recruiting]
`Köln, Nordrhein-Westfalen, Germany, 50931
`Germany, Rheinland-Pfalz
`[Not yet recruiting]
`Ludwigshafen, Rheinland-Pfalz, Germany, 67063
`[Not yet recruiting]
`Mainz, Rheinland-Pfalz, Germany, 55131
`Germany, Saarland
`[Not yet recruiting]
`Homburg, Saarland, Germany, 66421
`Germany, Sachsen
`[Not yet recruiting]
`Chemnitz, Sachsen, Germany, 09116
`[Not yet recruiting]
`Dresden, Sachsen, Germany, 01067
`[Not yet recruiting]
`Dresden, Sachsen, Germany, 01307
`[Not yet recruiting]
`Leipzig, Sachsen, Germany, 04103
`Germany, Schleswig-Holstein
`[Not yet recruiting]
`Kiel, Schleswig-Holstein, Germany, 24105
`[Not yet recruiting]
`Lübeck, Schleswig-Holstein, Germany, 23538
`Germany
`[Not yet recruiting]
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`Hamburg, Germany, 20251
`Hungary
`[Not yet recruiting]
`Budapest, Hungary, 1036
`[Not yet recruiting]
`Budapest, Hungary, 1089
`[Not yet recruiting]
`Budapest, Hungary, 1106
`[Not yet recruiting]
`Debrecen, Hungary, 4032
`[Not yet recruiting]
`Veszprem, Hungary, 8200
`Italy
`[Not yet recruiting]
`Ancona, Italy, 60126
`[Not yet recruiting]
`Bari, Italy, 70124
`[Not yet recruiting]
`Catania, Italy, 95123
`[Not yet recruiting]
`Firenze, Italy, 50139
`[Not yet recruiting]
`Milano, Italy, 20122
`[Not yet recruiting]
`Milano, Italy, 20132
`[Not yet recruiting]
`Milano, Italy, 20157
`[Not yet recruiting]
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`Padova, Italy, 35128
`[Not yet recruiting]
`Roma, Italy, 00133
`[Not yet recruiting]
`Roma, Italy, 00185
`[Not yet recruiting]
`Torino, Italy, 10128
`Japan, Aichi
`[Not yet recruiting]
`Nagoya, Aichi, Japan, 466-8560
`[Not yet recruiting]
`Nagoya, Aichi, Japan, 467-8602
`Japan, Chiba
`[Not yet recruiting]
`Urayasu, Chiba, Japan, 279-0021
`Japan, Osaka
`[Not yet recruiting]
`Suita, Osaka, Japan, 565-0871
`Japan, Tokyo
`[Not yet recruiting]
`Chiyoda-ku, Tokyo, Japan, 101-8309
`Japan
`[Not yet recruiting]
`Kyoto, Japan, 606-8507
`Korea, Republic of, Korea
`[Not yet recruiting]
`Seoul, Korea, Korea, Republic of, 110 744
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`Korea, Republic of
`[Not yet recruiting]
`Ask Contact, Korea, Republic of
`[Not yet recruiting]
`Incheon, Korea, Republic of, 405-760
`[Not yet recruiting]
`Kungki-do, Korea, Republic of, 463-707
`[Not yet recruiting]
`Seoul, Korea, Republic of, 110-744
`[Not yet recruiting]
`Seoul, Korea, Republic of, 138-736
`Latvia
`[Not yet recruiting]
`Riga, Latvia, 1009
`[Not yet recruiting]
`Riga, Latvia, LV-1002
`Singapore
`[Not yet recruiting]
`Ask Contact, Singapore, 168751
`[Not yet recruiting]
`Singapore, Singapore, 119074
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`IPDSharing
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`References
`
`Plan to Share IPD:
`
`Citations:
`Links:
`Available IPD/Information:
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`Scroll up to access the controls
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`Scroll to the Study top
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`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
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