12/22/2021
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`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`
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`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and
`Safety in Central Retinal Vein Occlusion (CRVO) (GALILEO)
`
`The safety and scientific validity of this study is the responsibility of the study sponsor
`and investigators. Listing a study does not mean it has been evaluated by the U.S.
`Federal Government. Read our disclaimer for details.
`
`
`ClinicalTrials.gov Identifier: NCT01012973
`
`Recruitment Status  : Completed
`First Posted  : November 13, 2009
`Results First Posted  : November 22, 2012
`Last Update Posted  : November 2, 2014
`
`Sponsor:
`Bayer
`
`Collaborator:
`
`https://clinicaltrials.gov/ct2/show/NCT01012973
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`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`Regeneron Pharmaceuticals
`
`Information provided by (Responsible Party):
`Bayer
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Go to
`
`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
`
`Condition or
`disease 
`
`Retinal Vein
`Occlusion
`
`Intervention/treatment 
`
`Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye,
`BAY86-5321)
`
`Other: Sham treatment
`
`Phase
`
`
`Phase 3
`
`Study Design
`
`Go to
`
`Study Type  :
`Interventional (Clinical Trial)
`Actual Enrollment  :
`177 participants
`Allocation:
`Randomized
`Intervention Model:
`Parallel Assignment
`Masking:
`Triple (Participant, Investigator, Outcomes Assessor)
`Primary Purpose:
`Treatment
`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)
`
`https://clinicaltrials.gov/ct2/show/NCT01012973
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`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`
`Study Start Date  :
`October 2009
`Actual Primary Completion Date  :
`February 2011
`Actual Study Completion Date  :
`February 2012
`
`Resource links provided by the National Library of Medicine
`
`MedlinePlus related topics: Edema
`
`Drug Information available for: Aflibercept Ziv-aflibercept
`
`U.S. FDA Resources
`
`Arms and Interventions
`
`Go to
`
`Arm 
`
`Intervention/treatment 
`
`Experimental: Aflibercept Injection (EYLEA, VEGF
`Trap-Eye, BAY86-5321)
`Participants received a 2 mg dose of Intravitreal
`Aflibercept Injection (IAI) administered every 4
`weeks from Day 1 through Week 20, later as
`often as every 4 weeks depending on the study
`retreatment criteria from Week 24 through Week
`48. Follow-up phase: Participants on IAI, who
`continued the study, received 2 mg dose of IAI
`depending on the study retreatment criteria at
`Week 60 and 68.
`
`Biological: Aflibercept Injection (EYLEA, VEGF Trap-
`Eye, BAY86-5321)
`Intravitreal injection. Weeks 0 to 20 of Aflibercept
`Injection every 4 weeks; Weeks 24 to 52 every 4
`weeks PRN (pro re nata, on demand); plus
`additional on Week 60 and 68.
`
`Other: Sham treatment
`Sham treatment. Weeks 0 to 52 sham treatment
`every 4 weeks; plus additional on Week 60 and
`68.
`
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`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
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`Arm 
`
`Intervention/treatment 
`
`Sham Comparator: Sham treatment
`Participants received sham treatment
`administered every 4 weeks from Day 1 through
`Week 52. Follow-up phase: Participants on sham
`treatment, who switched to Intravitreal Aflibercept
`Injection (IAI), received a 2 mg dose of IAI at
`week 52 and depending on the study retreatment
`criteria at Week 60 and 68.
`
`Other: Sham treatment
`Sham treatment. Weeks 0 to 52 sham treatment
`every 4 weeks; plus additional on Week 60 and
`68.
`
`Outcome Measures
`
`Go to
`
`Primary Outcome Measures  :
`1. 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 Failures [ Time Frame: Baseline and Week 24 ]
`
`Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected
`Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher
`score represents better functioning. Nominator = (Number of participants who maintained vision *
`100); Denominator = Number of participants analyzed.
`
`Secondary Outcome Measures  :
`1. Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study
`(ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
`[ Time Frame: Baseline and Week 24 ]
`
`Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (=
`Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However,
`because this was assessed at the screening visit, subjects may have had a higher BCVA recorded
`at the baseline visit and would not have been excluded from the study.
`
`2. Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
`[ Time Frame: Baseline and Week 24 ]
`3. Percentage of Participants Who Developed Neovascularization During the First 24 Weeks
`[ Time Frame: From baseline until Week 24 ]
`
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`Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to
`Week 24
`
`4. Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-
`25) Total Score at Week 24 - LOCF [ Time Frame: Baseline and Week 24 ]
`
`The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100
`being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which
`are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in
`order to give each sub-scale equal weight
`
`5. Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 -
`LOCF [ Time Frame: Baseline and Week 24 ]
`
`EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).
`
`Eligibility Criteria
`
`Go to
`
`Information from the National Library of Medicine
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family
`members or friends about deciding to join a study. To learn more about this study, you or your doctor may
`contact the study research staff using the contacts provided below. For general information, Learn About
`Clinical Studies.
`
`Ages Eligible for Study:
`18 Years and older (Adult, Older Adult)
`Sexes Eligible for Study:
`All
`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)
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`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
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`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
`
`Contacts and Locations
`
`Go to
`
`Information from the National Library of Medicine
`
`To learn more about this study, you or your doctor may contact the study research staff using the contact
`information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012973
`
`Locations
`
` Show 73 study locations
`
`Sponsors and Collaborators
`Bayer
`
`Regeneron Pharmaceuticals
`
`Investigators
`Study Director: Bayer Study Director Bayer
`
`More Information
`
`Additional Information:
`
`Go to
`
`https://clinicaltrials.gov/ct2/show/NCT01012973
`
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`Click here to find information about studies related to Bayer Healthcare products conducted in Europe
`
`Publications of Results:
`
`Holz FG, Roider J, Ogura Y, Korobelnik JF, Simader C, Groetzbach G, Vitti R, Berliner AJ, Hiemeyer F,
`Beckmann K, Zeitz O, Sandbrink R. VEGF Trap-Eye for macular oedema secondary to central retinal vein
`occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013 Mar;97(3):278-84. doi:
`10.1136/bjophthalmol-2012-301504. Epub 2013 Jan 7. Erratum in: Br J Ophthalmol. 2015 Dec;99(12):1746.
`
`Korobelnik JF, Holz FG, Roider J, Ogura Y, Simader C, Schmidt-Erfurth U, Lorenz K, Honda M, Vitti R, Berliner
`AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal Aflibercept Injection for
`Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO
`Study. Ophthalmology. 2014 Jan;121(1):202-208. doi: 10.1016/j.ophtha.2013.08.012. Epub 2013 Sep 29.
`
`Responsible Party:
`Bayer
`ClinicalTrials.gov Identifier:
`NCT01012973 History of Changes
`Other Study ID Numbers:
`14130
`2009-010973-19 ( EudraCT Number )
`First Posted:
`November 13, 2009 Key Record Dates
`Results First Posted:
`November 22, 2012
`Last Update Posted:
`November 2, 2014
`Last Verified:
`October 2014
`
`Keywords provided by Bayer:
`Macular Edema
`Central Retinal Vein Occlusion
`CRVO
`VEGF Trap-Eye
`best-corrected visual acuity
`
`Additional relevant MeSH terms:
`
`https://clinicaltrials.gov/ct2/show/NCT01012973
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`12/22/2021
`Retinal Vein Occlusion
`Retinal Diseases
`Eye Diseases
`Venous Thrombosis
`Thrombosis
`Embolism and Thrombosis
`Vascular Diseases
`Cardiovascular Diseases
`Aflibercept
`Angiogenesis Inhibitors
`Angiogenesis Modulating Agents
`Growth Substances
`Physiological Effects of Drugs
`Growth Inhibitors
`Antineoplastic Agents
`
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