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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)
`
`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: NCT00943072
`
`Recruitment Status : Completed
`First Posted : July 21, 2009
`Results First Posted : May 27, 2013
`Last Update Posted : May 27, 2013
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`Sponsor:
`Regeneron Pharmaceuticals
`
`Collaborator:
`Bayer
`
`Information provided by (Responsible Party):
`Regeneron Pharmaceuticals
`
`Study Details
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`Tabular View
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`Study Results
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`Disclaimer
`
`How to Read a Study Record
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`Study Description
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`Brief Summary:
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`Go to
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`https://clinicaltrials.gov/ct2/show/NCT00943072
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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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`This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects
`with macular edema as a consequence of central retinal vein occlusion.
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`Condition or disease
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`Intervention/treatment
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`Macular Edema Secondary to Central Retinal
`Vein Occlusion
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`Biological: VEGF Trap-Eye
`2.0mg
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`Phase
`
`
`Phase 3
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`Study Design
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`Drug: Sham
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`Go to
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`Study Type :
`Interventional (Clinical Trial)
`Actual Enrollment :
`189 participants
`Allocation:
`Randomized
`Intervention Model:
`Parallel Assignment
`Masking:
`Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose:
`Treatment
`Official Title:
`A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of
`Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With
`Macular Edema Secondary to Central Retinal Vein Occlusion
`Study Start Date :
`July 2009
`Actual Primary Completion Date :
`October 2010
`Actual Study Completion Date :
`April 2012
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`Resource links provided by the National Library of Medicine
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`https://clinicaltrials.gov/ct2/show/NCT00943072
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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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`MedlinePlus related topics: Edema
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`Drug Information available for: Aflibercept Ziv-aflibercept
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`U.S. FDA Resources
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`Arms and Interventions
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`Go to
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`Arm
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`Intervention/treatment
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`Experimental: VEGF Trap-Eye
`Monthly IVT injection of VEGF Trap-Eye 2.0 mg
`until Week 24 Primary Endpoint
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`Biological: VEGF Trap-Eye 2.0mg
`Monthly intravitreal injection out to the Week 24
`Primary endpoint
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`Sham Comparator: Sham
`Monthly Sham IVT injection until Week 24
`Primary Endpoint
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`Drug: Sham
`Monthly sham intravitreal injection out to Week 24
`Primary Endpoint
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`Outcome Measures
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`Go to
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`Primary Outcome Measures :
`1. Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by
`ETDRS Letter Score [ Time Frame: Baseline and at Week 24 ]
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`Percentage values indicate the number of subjects in each arm who were able to read an additional 15
`letters or more at Week 24 compared to baseline.
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`Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (=
`Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
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`Secondary Outcome Measures :
`1. Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last
`Observation Carried Forward (LOCF) [ Time Frame: Baseline and at 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.
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`2. Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
`[ Time Frame: Baseline and at Week 24 ]
`3. Percentage of Participants Progressing to Any of the Following: Anterior Segment
`Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the
`First 24 Weeks [ Time Frame: Baseline to Week 24 ]
`4. Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)
`[ Time Frame: Baseline and at Week 24 ]
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`The NEI VFQ-25 assesses visual function and quality of life. 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.
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`Eligibility Criteria
`
`Go to
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`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:
`
`Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean
`central retinal thickness ≥ 250 μm on OCT
`ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye
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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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`Exclusion Criteria:
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`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
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`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): NCT00943072
`
`Locations
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` Show 61 study locations
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`Sponsors and Collaborators
`Regeneron Pharmaceuticals
`
`Bayer
`
`Investigators
`Study Director: Clinical Trial Management Regeneron Pharmaceuticals
`
`More Information
`
`Go to
`
`Responsible Party:
`Regeneron Pharmaceuticals
`ClinicalTrials.gov Identifier:
`NCT00943072 History of Changes
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`https://clinicaltrials.gov/ct2/show/NCT00943072
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`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…
`
`Other Study ID Numbers:
`VGFT-OD-0819
`First Posted:
`July 21, 2009 Key Record Dates
`Results First Posted:
`May 27, 2013
`Last Update Posted:
`May 27, 2013
`Last Verified:
`April 2013
`
`Keywords provided by Regeneron Pharmaceuticals:
`Macular edema
`best-corrected visual acuity
`Retinal vein occlusion
`Regeneron
`CRVO
`COPERNICUS
`VEGF Trap-Eye
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`Additional relevant MeSH terms:
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`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`12/22/2021
`Neoplasm Metastasis
`Macular Edema
`Retinal Vein Occlusion
`Edema
`Neoplastic Processes
`Neoplasms
`Pathologic Processes
`Macular Degeneration
`Retinal Degeneration
`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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