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`The U.S. government does not review or approve the safety and science of all studies
`listed on this website.
`Read our full disclaimer (https://clinicaltrials.gov/about-site/disclaimer) for details.
`
`
`
`COMPLETED
`Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema
`
`ClinicalTrials.gov ID NCT00320814
`
`Sponsor Regeneron Pharmaceuticals
`
`Information provided by Regeneron Pharmaceuticals
`
`Last Update Posted 2011-06-10
`
`Table View Tab
`
`Trial Contacts
`
`Contacts
`
`Contact information is only displayed when the study is recruiting subjects
`
`Study Record Dates
`
`First Submitted
`
`2006-04-28
`
`First Posted
`
`2006-05-03
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2012 Page 1
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Last Update Posted
`
`2011-06-10
`
`Last Veried
`
`2011-06
`
`Outcome Measures
`
`Change History
`
`See all versions of this study
`
`Primary (Current)
`(Submitted 2009 01 05)
`
`ICMJE
`
`
`
`To assess the ocular and systemic safety and tolerability of a single intravitreal (IVT) injection of
`VEGF Trap-Eye in patients with diabetic macular edema (DME) [Time Frame: Assessments for
`safety and tolerablity are performed at each visit (Visit 1 - Visit 10)]
`
`Primary (Original)
`(Submitted: 2006-04-28)
`
`Safety and tolerability, Bioeffect
`
`
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`Secondary (Current)
`(Submitted: 2009-01-05)
`
`ICMJE
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`ICMJE
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`
`
`
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`To obtain a preliminary assessment of the effect of a single dose of VEGF Trap-Eye on central
`retinal thickness (CRT) at the center point as determined by optical coherence tomography (OCT)
`[Time Frame: Assessments for CRT are performed at each visit (Visit 1 - Visit 10) by means of
`OCT.]
`To obtain a preliminary assessment of the effect of a single IVT administration of VEGF Trap-Eye
`on visual acuity [Time Frame: Assessments for visual acuity are performed at each visit (Visit 1 -
`Visit 10).]
`
`Secondary (Original)
`(Submitted: 2006-04-28)
`
`ICMJE
`
`
`
`The effect of VEGF Trap administration on central retinal thickness visual acuity and anti VEGF
`Trap antibodies in the systemic circulation
`
`Other Pre-specied (Current)
`
`Not provided
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2012 Page 2
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Other Pre-specied (Original)
`
`Not provided
`
`Trial Description
`
`Brief Title
`
`Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema
`
`Ocial Title
`
`An Exploratory Study of the Safety, Tolerability and Biological Effect of a Single Intravitreal
`Administration of VEGF Trap in Patients With Diabetic Macular Edema
`
`ICMJE
`
`ICMJE
`
`Brief Summary
`
`To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF
`Trap in patients with diabetic macular edema
`
`Detailed Description
`
`This is an open label study. Initially, 5 patients with DME will receive an ITV injection of VEGF Trap
`into the study eye. Additional patients may be enrolled at the same or additional dose levels.
`Patients will be observed for six weeks following the injection for assessments of ocular and
`systemic safety.
`
`Study Type
`
`Interventional
`
`Study Phase
`
`Phase 1
`
`Study Design
`
`Allocation:
`Non-Randomized
`Interventional Model:
`Single Group Assignment
`Masking:
`None (Open Label)
`Primary Purpose:
`Treatment
`
`ICMJE
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`ICMJE
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`ICMJE
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`Regeneron Pharmaceuticals, Inc. Exhibit 2012 Page 3
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Condition
`
`Diabetic Macular Edema
`
`
`
`Intervention
`
`
`
`Drug: VEGF Trap-Eye
`single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
`
`
`
`Study Arms
`
`
`
`Experimental: VEGF Trap-Eye
`single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
`
`
`
`
`
`Interventions:
`Drug: VEGF Trap-Eye
`
`
`
`Publications *
`
`Not provided
`
`ICMJE
`
`ICMJE
`
`ICMJE
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`* Includes publications given by the data provider as well as publications identied by ClinicalTrials.gov
`Identier (NCT Number) in Medline.
`
`Recruitment Information
`
`Recruitment Status
`
`Completed
`
`Enrollment (Actual)
`(Submitted: 2006-04-28)
`
`5
`
`Original Enrollment
`
`Same as current
`
`Study Start Date
`
`2006-04
`
`Primary Completion Date (Actual)
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2012 Page 4
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`2006-08 (Final data collection date for primary outcome measure)
`
`Study Completion Date (Actual)
`
`2007-08
`
`Eligibility Criteria
`
`Inclusion Criteria:
`
`ICMJE
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`ICMJE
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`
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`Diagnosis of diabetes mellitus (type 1 or type 2).
`Best corrected E-ETDRS visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤ 73
`letters (i.e., 20/40 or worse).
`On clinical exam, denite retinal thickening due to diabetic macular edema involving the
`center of the macula.
`Retinal Thickness at the center point ≥ 250 microns.
`Media clarity, pupillary dilation, and patient cooperation sucient for adequate fundus
`photographs.
`
`Exclusion Criteria
`
`
`
`
`
`
`
`
`
`
`History of any vitreous hemorrhage within 4 weeks prior to Visit 2 (Day 1).
`Macular edema due to causes other than diabetic macular edema. An eye should be
`considered ineligible: (1) if the macular edema is considered to be related to cataract
`extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease
`(e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular
`edema.
`An ocular condition is present such that, in the opinion of the investigator, visual acuity
`would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary
`changes, dense subfoveal hard exudates, nonretinal condition).
`An ocular condition is present (other than diabetes) that, in the opinion of the investigator,
`might affect macular edema or alter visual acuity during the course of the study (e.g., vein
`occlusion, age-related macular degeneration, uveitis or other ocular inammatory disease,
`neovascular glaucoma, Irvine-Gass Syndrome, etc.).
`Presence of any other condition or laboratory abnormality which in the opinion of the
`Investigator would interfere with the assessment of disease status/progression or
`jeopardize the patient s appropriate participation in this Phase 1 study
`
`Sex/Gender
`
`Sexes Eligible for the Study
`All
`
`Ages
`
`18 Years and older (Adult   Older Adult )
`
`Accepts Healthy Volunteers
`
`No
`
`Location Countries
`
`United States
`
`ICMJE
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`ICMJE
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`ICMJE
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`ICMJE
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`Regeneron Pharmaceuticals, Inc. Exhibit 2012 Page 5
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Removed Location Countries
`
`Administrative Information
`
`NCT Number
`
`NCT00320814
`
`Other Study ID Numbers
`
`VGFT-OD-0512
`
`Has Data Monitoring Committee
`
`No
`
`U.S. FDA-regulated Product
`
`Not provided
`
`IPD Sharing Statement
`
`Not provided
`
`Current Responsible Party
`
`Avner Ingerman, MD/Medical Monitor, Regeneron Pharmaceuticals, Inc.
`
`Original Responsible Party
`
`Not provided
`
`Current Study Sponsor
`
`Regeneron Pharmaceuticals
`
`Original Study Sponsor
`
`Same as current
`
`Collaborators
`
`Not provided
`
`ICMJE
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`ICMJE
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`ICMJE
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`ICMJE
`
`ICMJE
`
`ICMJE
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`Regeneron Pharmaceuticals, Inc. Exhibit 2012 Page 6
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Investigators
`
`Study Director:
`Avner Ingerman, MD
`Regeneron Pharmaceuticals
`
`PRS Account
`
`Regeneron Pharmaceuticals
`
`ICMJE
`
`International Committee of Medical Journal Editors
`ICMJE Data element required by the
`and the
`World Health Organization ICTRP
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2012 Page 7
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`