12/22/2021
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`
`Try the modernized ClinicalTrials.gov beta website. Learn more about the
`modernization effort.
`
`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
`
`Sponsor:
`Regeneron Pharmaceuticals
`
`Collaborator:
`Bayer
`
`Information provided by (Responsible Party):
`Regeneron Pharmaceuticals
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Brief Summary:
`
`Go to
`
`https://clinicaltrials.gov/ct2/show/NCT00943072
`
`1/7
`
`Exhibit 2126
`Page 01 of 07
`
`
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`
`Try the modernized ClinicalTrials.gov beta website. Learn more about the
`modernization effort.
`
`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
`
`Sponsor:
`Regeneron Pharmaceuticals
`
`Collaborator:
`Bayer
`
`Information provided by (Responsible Party):
`Regeneron Pharmaceuticals
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Brief Summary:
`
`Go to
`
`https://clinicaltrials.gov/ct2/show/NCT00943072
`
`1/7
`
`Exhibit 2126
`Page 01 of 07
`
`
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`12/22/2021
`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.
`
`Condition or disease
`
`Intervention/treatment
`
`Macular Edema Secondary to Central Retinal
`Vein Occlusion
`
`Biological: VEGF Trap-Eye
`2.0mg
`
`Phase
`
`
`Phase 3
`
`Study Design
`
`Drug: Sham
`
`Go to
`
`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
`
`Resource links provided by the National Library of Medicine
`
`https://clinicaltrials.gov/ct2/show/NCT00943072
`
`2/7
`
`Exhibit 2126
`Page 02 of 07
`
`
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`12/22/2021
`MedlinePlus related topics: Edema
`
`Drug Information available for: Aflibercept Ziv-aflibercept
`
`U.S. FDA Resources
`
`Arms and Interventions
`
`Go to
`
`Arm
`
`Intervention/treatment
`
`Experimental: VEGF Trap-Eye
`Monthly IVT injection of VEGF Trap-Eye 2.0 mg
`until Week 24 Primary Endpoint
`
`Biological: VEGF Trap-Eye 2.0mg
`Monthly intravitreal injection out to the Week 24
`Primary endpoint
`
`Sham Comparator: Sham
`Monthly Sham IVT injection until Week 24
`Primary Endpoint
`
`Drug: Sham
`Monthly sham intravitreal injection out to Week 24
`Primary Endpoint
`
`Outcome Measures
`
`Go to
`
`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 ]
`
`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.
`
`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.
`
`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.
`
`https://clinicaltrials.gov/ct2/show/NCT00943072
`
`3/7
`
`Exhibit 2126
`Page 03 of 07
`
`
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`12/22/2021
`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 ]
`
`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.
`
`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:
`
`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
`
`https://clinicaltrials.gov/ct2/show/NCT00943072
`
`4/7
`
`Exhibit 2126
`Page 04 of 07
`
`
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - F…
`12/22/2021
`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 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
`
` Show 61 study locations
`
`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
`
`https://clinicaltrials.gov/ct2/show/NCT00943072
`
`5/7
`
`Exhibit 2126
`Page 05 of 07
`
`
`
`12/22/2021
`
`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
`
`Additional relevant MeSH terms:
`
`https://clinicaltrials.gov/ct2/show/NCT00943072
`
`6/7
`
`Exhibit 2126
`Page 06 of 07
`
`
`
`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
`
`https://clinicaltrials.gov/ct2/show/NCT00943072
`
`7/7
`
`Exhibit 2126
`Page 07 of 07
`
`
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