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`Study Record | ClinicalTrials.gov
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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
`DME And VEGF Trap-Eye [Intravitreal Aibercept Injection (IAI;EYLEA®;BAY86-
`5321)] INvestigation of Clinical Impact (DA VINCI)
`
`ClinicalTrials.gov ID NCT00789477
`
`Sponsor Regeneron Pharmaceuticals
`
`Information provided by Regeneron Pharmaceuticals (Responsible Party)
`
`Last Update Posted 2014-09-09
`
`Table View Tab
`
`Trial Contacts
`
`Contacts
`
`Contact information is only displayed when the study is recruiting subjects
`
`Study Record Dates
`
`First Submitted
`
`2008-11-07
`
`First Posted
`
`https://clinicaltrials.gov/study/NCT00789477?tab=table
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`
`
`1/8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2016 Page 1
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`

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`8/21/23, 1:34 PM
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`2008-11-11
`
`Study Record | ClinicalTrials.gov
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`Results First Submitted
`
`2014-08-28
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`Results First Posted
`
`2014-09-09
`
`Last Update Posted
`
`2014-09-09
`
`Last Veried
`
`2014-08
`
`Outcome Measures
`
`Change History
`
`See all versions of this study
`
`Primary (Current)
`(Submitted 2014 08 28)
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`
`
`Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF) [Time
`Frame: At week 24]
`
`
`
`Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy
`Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.
`
`Missing values were imputed with post-baseline values during on-treatment period by using
`last observation carried forward (LOCF).
`
`Primary (Original)
`(Submitted 2008 11 07)
`
`Change in best corrected visual acuity
`
`
`
`Secondary (Current)
`(Submitted: 2014-08-28)
`
`ICMJE
`
`ICMJE
`
`
`
`Change in BCVA From Baseline to Week 52 - LOCF [Time Frame: At week 52]
`Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy
`Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values
`during on-treatment period by using last observation carried forward (LOCF).
`https://clinicaltrials.gov/study/NCT00789477?tab=table
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`2/8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2016 Page 2
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

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`8/21/23, 1:34 PM
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`Study Record | ClinicalTrials.gov
`Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF [Time Frame: At
`week 24 and week 52]
`Missing values were imputed with post-baseline values during on-treatment period by using
`last observation carried forward (LOCF).
`Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence
`Tomography (OCT) - LOCF [Time Frame: At week 24 and week 52]
`Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were
`imputed with post-baseline values during on-treatment period by using last observation
`carried forward (LOCF).
`Number of Focal Laser Treatments [Time Frame: Week 1 to week 48]
`
`
`
`ICMJE
`
`Secondary (Original)
`(Submitted: 2008-11-07)
`
`Change from baseline in foveal thickness
`
`
`
`Other Pre-specied (Current)
`
`Not provided
`
`Other Pre-specied (Original)
`
`Not provided
`
`Trial Description
`
`Brief Title
`
`ICMJE
`
`DME And VEGF Trap-Eye [Intravitreal Aibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation
`of Clinical Impact
`
`Ocial Title
`
`ICMJE
`
`A Double Masked Randomized Controlled Study of the Safety Tolerability and Biological Effect of
`Repeated Intravitreal Administration of VEGF Trap Eye in Patients With Diabetic Macular Edema
`(DME)
`
`Brief Summary
`
`This is a Phase 2, doubled-masked, randomized study of the ecacy and safety of Intravitreal
`Aibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME).
`Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.
`
`Detailed Description
`
`Qualied subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of
`the study will be 52 weeks, with a 6 month safety follow-up
`
`https://clinicaltrials.gov/study/NCT00789477?tab=table
`
`3/8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2016 Page 3
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
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`8/21/23, 1:34 PM
`
`Study Record | ClinicalTrials.gov
`
`Study Type
`
`Interventional
`
`Study Phase
`
`Phase 2
`
`Study Design
`
`Allocation:
`Randomized
`Interventional Model:
`Parallel Assignment
`Masking:
`Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose:
`Treatment
`
`Condition
`
`Diabetic Macular Edema
`
`
`
`Intervention
`
`
`
`
`
`Procedure: Laser Photocoagulation
`laser every 16 weeks as needed
`
`
`
`
`
`Other Names:
`macular laser therapy
`
`
`
`Drug: Intravitreal Aibercept Injection
`Other Names:
`IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
`
`
`
`
`
`Study Arms
`
`Experimental: Intravitreal Aibercept Injection .5Q4
`Intravitreal Aibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
`
`
`
`
`
`Interventions:
`Drug: Intravitreal Aibercept Injection
`
`
`
`Experimental: Intravitreal Aibercept Injection 2Q4
`Intravitreal Aibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
`
`
`
`
`
`Interventions:
`Drug: Intravitreal Aibercept Injection
`
`
`
`Experimental: Intravitreal Aibercept Injection 2Q8
`
`
`
`
`
`
`
`https://clinicaltrials.gov/study/NCT00789477?tab=table
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`4/8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2016 Page 4
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

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`8/21/23, 1:34 PM
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`Study Record | ClinicalTrials.gov
`Intravitreal Aibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits
`followed by every 8 weeks
`
`
`
`
`
`Interventions:
`Drug: Intravitreal Aibercept Injection
`
`
`Experimental: Intravitreal Aibercept Injection 2PRN
`Intravitreal Aibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits
`followed by PRN (as-needed) dosing according to the re-treatment criteria
`
`
`
`
`
`Interventions:
`Drug: Intravitreal Aibercept Injection
`
`
`Active Comparator: Laser Photocoagulation
`Focal laser at week 1, and one week after visits at which the participant met laser re-
`treatment criteria to the end of the study (week 52) starting at week 16; laser re-
`treatment was permitted no more than once every 16 weeks.
`
`
`
`
`
`Interventions:
`Procedure: Laser Photocoagulation
`
`
`
`Publications *
`
`Not provided
`
`* 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: 2014-08-28)
`
`221
`
`Original Enrollment (Estimated)
`(Submitted: 2008-11-07)
`
`200
`
`Study Start Date
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`https://clinicaltrials.gov/study/NCT00789477?tab=table
`
`5/8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2016 Page 5
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`8/21/23, 1:34 PM
`
`2008-12
`
`Study Record | ClinicalTrials.gov
`
`Primary Completion Date (Actual)
`
`2009-12 (Final data collection date for primary outcome measure)
`
`Study Completion Date (Actual)
`
`2010-09
`
`Eligibility Criteria
`
`Inclusion Criteria:
`
`ICMJE
`
`ICMJE
`
`Patients with clinically signicant DME with central involvement
`Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
`ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye
`
`
`
`
`Exclusion Criteria:
`
`
`
`
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`
`
`
`
`
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`
`
`History of vitreoretinal surgery in the study eye
`Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within
`3 months of screening
`Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of
`screening
`Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave
`acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
`Uncontrolled diabetes mellitus
`Uncontrolled hypertension dened as systolic > 180mmHg or > 160 mmHg on 2
`consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
`Ocular disorders in the study eye, other than DME, that may confound interpretation of
`study results
`
`Sex/Gender
`
`Sexes Eligible for the Study:
`All
`
`Ages
`
`18 Years and older (Adult,  Older Adult )
`
`Accepts Healthy Volunteers
`
`No
`
`Location Countries
`
`Austria,  Canada,  United States
`
`Removed Location Countries
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`https://clinicaltrials.gov/study/NCT00789477?tab=table
`
`6/8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2016 Page 6
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`8/21/23, 1:34 PM
`
`Study Record | ClinicalTrials.gov
`
`Administrative Information
`
`NCT Number
`
`NCT00789477
`
`Other Study ID Numbers
`
`VGFT-OD-0706
`
`Has Data Monitoring Committee
`
`No
`
`U.S. FDA-regulated Product
`
`Not provided
`
`IPD Sharing Statement
`
`Not provided
`
`Current Responsible Party
`
`Regeneron Pharmaceuticals
`
`Original Responsible Party
`
`Therapeutic Area Head, Regeneron Pharmaceuticals, Inc.
`
`Current Study Sponsor
`
`Regeneron Pharmaceuticals
`
`Original Study Sponsor
`
`Same as current
`
`Collaborators
`
`Bayer
`
`Investigators
`
`Study Director:
`Clinical Trial Management
`
`https://clinicaltrials.gov/study/NCT00789477?tab=table
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`ICMJE
`
`7/8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2016 Page 7
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`8/21/23, 1:34 PM
`Regeneron Pharmaceuticals
`
`Study Record | ClinicalTrials.gov
`
`PRS Account
`
`Regeneron Pharmaceuticals
`
`International Committee of Medical Journal Editors
`ICMJE Data element required by the
`World Health Organization ICTRP
`and the
`
`https://clinicaltrials.gov/study/NCT00789477?tab=table
`
`8/8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2016 Page 8
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

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