12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`ee
`
`ClinicalTrials.gov
`
`e
`
`Go to
`
`the
`
`classi
`
`nn
`
`bsit
`
`fev
`
`iy
`
`The U.S. government doesnot review or approve the safety and scienceofall studies
`
`A listed on this website.
`
`Read our full disclaimer (https://clinicaltrials.gov/about-site/disclaimer) for details.
`
`+
`
`COMPLETED @
`
`A Study of RanibizumabInjection in Subjects With Clinically Significant
`Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus
`(RISE) (RISE)
`
`ClinicalTrials.gov ID @ NCT00473330
`
`Sponsor a Genentech,Inc.
`
`Information provided by @ Genentech,Inc. (Responsible Party)
`
`Last Update Posted @ 2017-04-17
`
`Record History Tab
`
`Study Record Versions
`
`¢ This table showsthelist of all the versions of this study record arrangedin order by date.
`e Thefirst column showsthe date the study record was updated, and the second column showsthe
`elementsin the study record that were changed.
`e To view a version of a study record,click the version date.
`e To compareversions, select two versions using the check boxesandclick the "Compare" button at the
`bottom ofthelist.
`
`C)
`C)
`
`2007-05-13
`2007-07-12
`
`None(earliest version on record)
`Recruitment Status
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`
`
`1/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 1
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`Study Status
`
`Contacts/Locations
`
`(J
`
`C)
`
`2007-08-06
`
`Study Status
`
`Contacts/Locations
`
`2
`
`7-09-12
`
`Study Status
`
`Contacts/Locations
`
`Study Status
`Conditions
`
`Arms and Interventions
`
`Outcome Measures
`
`Eligibility
`
`Contacts/Locations
`
`Study Identification
`Study Description
`
`Study Status
`Contacts/Locations
`
`Study Identification
`
`Conditions
`
`Study Design
`Arms and Interventions
`
`Sponsor/Collaborators
`Outcome Measures
`
`Eligibility
`
`Recruitment Status
`
`Study Status
`
`Study Status
`Contacts/Locations
`
`Outcome Measures
`
`2010-11-11
`
`Study Status
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`2/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 2
`
`C)
`
`2008-09-24
`
`C)
`
`2009-02-02
`
`2009-11-02
`
`()
`
`()
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`C)
`
`2012-12-10
`
`Study Status
`Study Identification
`Sponsor/Collaborators
`Study Description
`Conditions
`
`Study Design
`Armsand Interventions
`
`Outcome Measures
`
`Eligibility
`Participant Flow
`Baseline Characteristics
`
`Adverse Events
`
`MoreInformation
`
`C)
`
`2013-07-31
`
`Recruitment Status
`
`Study Status
`
`0
`
`Study Status
`Study Description
`Arms and Interventions
`
`Outcome Measures
`Participant Flow
`Baseline Characteristics
`
`Adverse Events
`
`More Information
`
`Date
`
`Changes
`
`Version 9: 2010-11-11
`
`Date
`
`Changes
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`
`
`3/14
`
`IPR2023-00884
`Samsung etal. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page3
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`StudyIdentification
`
`Unique Protocol ID
`
`FVF4170g
`
`Brief Title
`
`A Study of RanibizumabInjection in Subjects With Clinically
`Significant Macular Edema With Center Involvement Secondary
`to Diabetes Mellitus (RISE)
`
`Official Title
`
`A PhaseIII, Double-Masked, Multicenter, Randomized, Sham
`Injection-Controlled Study of the Efficacy and Safety of
`RanibizumabInjection in Subjects With Clinically Significant
`Macular Edema With Center Involvement Secondary to Diabetes
`Mellitus
`
`Secondary IDs
`
`Study Status
`
`Record Verification
`
`2010-11
`
`Overall Status
`
`Active, not recruiting
`
`Study Start
`
`2007-07
`
`Primary Completion
`
`2012-10 [Estimated]
`
`Study Completion
`
`Date
`
`Changes
`
`2007-05-13
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`4/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 4
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`First Submitted that Met QC Criteria
`
`2007-05-13
`
`First Posted
`
`2007-05-15
`
`Last Update Submitted that Met QC Criteria
`
`2010-11-11
`
`Last Update Posted
`
`2010-11-15 [Estimated]
`
`Sponsor/Collaborator
`
`Sponsor
`
`Genentech,Inc.
`
`Responsible Party
`
`Collaborators
`
`Oversight
`
`U.S. FDA-regulated Drug
`
`U.S. FDA-regulated Device
`
`Data Monitoring
`
`Study Description
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`5/14
`
`IPR2023-00884
`Samsungetal. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 5
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`Brief Summary
`
`This study is a PhaseIII, double-masked, multicenter,
`randomized, sham injection-controlled study of the efficacy and
`safety of ranibizumabinjection in patients with CSME-Cl
`secondary to diabetes mellitus (Type 1 or 2).
`
`Detailed Description
`
`Conditions
`
`Condition
`
`Diabetes Mellitus
`
`Macular Edema
`
`Keywords
`
`Lucentis
`
`DME
`
`Diabetes
`
`Vision Loss
`
`Study Design
`
`Study Type
`
`Interventional
`
`Primary Purpose
`
`Treatment
`
`Study Phase
`
`Phase 3
`
`Interventional Study Model
`
`Parallel Assignment
`
`Interventional ModelDescription
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`6/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 6
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`Numberof Arms
`
`3 M
`
`asking
`
`Double (Participant, Investigator)
`
`Masking Description
`
`Allocation
`
`Randomized
`
`Enrollment
`
`366 [Estimated]
`
`ArmsandInterventions
`
`Arms
`
`Assigned Interventions
`
`Experimental: 1
`
`Drug: ranibizumab
`
`e
`
`Intravitreal injection
`repeating dose
`
`Experimental: 2
`
`Drug: ranibizumab
`
`¢
`
`Intravitreal injection
`repeating dose
`
`Sham Comparator: 3
`
`Drug: sham
`
`e
`
`Intravitreal sham inje
`repeating dose
`
`Outcome Measures
`
`Primary Outcome Measures
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`7/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 7
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`1. Theprimary efficacy outcome measureis the proportion of
`subjects whogain at least 15 letters in BCVA compared with
`baseline
`[Time Frame: 24 months]
`
`Secondary Outcome Measures
`
`1.
`
`oi
`
`Mean changefrom baseline in BCVA score over time
`[Time Frame: 24 months]
`. Mean changefrom baseline in central foveal thickness (CFT)
`over time, as assessed on OCTbythe central reading center
`[Time Frame: 24 months]
`. Proportion of subjects with resolution of leakage at 24
`months, as assessed bythe central reading center using
`fluorescein angiography (FA)
`[Time Frame: 24 months]
`Mean numberof macularlaser treatments during 24 months
`[Time Frame: 24 months]
`. Mean change from baseline in the National Eye Institute Visual
`Functioning Questionnaire-25 (NEI VFQ-25) nearactivities
`subscale score at 24 months
`[Time Frame: 24 months]
`. Mean changefrom baseline in the NEI VFQ-25 distance
`activities subscale score at 24 months
`[Time Frame: 24 months]
`. Proportion of subjects with a three-step change from baseline
`in the Early Treatment Diabetic Retinopathy Study (ETDRS)
`scale at 24 months,as assessedbythe central reading center
`using fundus photography
`[Time Frame: 24 months]
`. Mean change from baseline in contrast sensitivity at 24
`months, measured by the numberofletters read correctly on
`the Pelli-Robson chart
`[Time Frame: 24 months]
`. Proportion of subjects whogain at least 15 letters in BCVA
`score compared with baseline at 36 months
`[Time Frame: 36 months]
`Meanchangefrom baseline in BCVA score over time up to 36
`months
`
`10.
`
`11.
`
`[Time Frame: 36 months]
`Mean changefrom baselinein central foveal thickness (CFT)
`over time up to 36 months, as assessed on OCTbythecentral
`reading center
`[Time Frame: 36 months]
`12. Mean numberof macularlaser treatments during 36 months
`[Time Frame: 36 months]
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`8/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 8
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`13. Proportion of subjects with a three-step or greater progression
`from baseline in the ETDRSdiabetic retinopathy severity level
`at 36 months, as assessed by the central reading center using
`FP
`
`[Time Frame: 36 months]
`14. Mean changefrom baseline in contrast sensitivity at 36
`months, as measured by the numberofletters read correctly
`on the Pelli-Robson chart
`
`[Time Frame: 36 months]
`
`Eligibility
`
`Minimum Age
`
`18 Years
`
`Maximum Age
`
`Sex
`
`All
`
`Accepts Healthy Volunteers
`
`No
`
`Criteria
`
`Inclusion Criteria:
`
`¢ Willingness to provide written informed consentand,at
`U.S. sites, Health Insurance Portability and Accountability
`Act (HIPAA) authorization and in other countries, as
`applicable according to national laws
`« Age= 18 years
`¢ Diabetes mellitus (Type 1 or 2)
`e Retinal thickening secondary to diabetes mellitus (DME)
`involving the center of the fovea
`e Decreasein vision determined to be primarily the result of
`DME and not to other causes
`¢ For sexually active womenofchildbearing potential, use of
`an appropriate form of contraception (or abstinence)for
`the duration of the study
`e Ability (in the opinion of the investigator) and willingness
`to return for all scheduled visits and assessments
`
`Exclusion Criteria:
`
`¢ History of vitreoretinal surgery in the study eye
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`9/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page9
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`Panretinal photocoagulation (PRP) or macular laser
`photocoagulationin the study eye within 3 months of
`screening
`Previous useofintraocular corticosteroids in the study eye
`(e.g., TA) within 3 months of screening
`Previous treatment with anti-angiogenic drugsin either eye
`(pegaptanib sodium, anecortave acetate, bevacizumab,
`ranibizumab,etc.) within 3 monthsof the Day0visit
`PDRin the study eye, with the exception of inactive,
`regressed PDR
`lris neovascularization, vitreous hemorrhage,traction
`retinal detachment, or preretinal fibrosis involving the
`macula in the study eye Concurrent Ocular Conditions
`Vitreomacular traction or epiretinal membranein the study
`eye
`Ocularinflammation (including trace or above) in the study
`eye
`History of idiopathic or autoimmuneuveitis in either eye
`Structural damageto the center of the macula in the study
`eye thatis likely to preclude improvementin VA following
`the resolution of macular edema,including atrophy of the
`RPE,subretinal fibrosis, or organized hard-exudate plaque
`Ocular disorders in the study eye that may confound
`interpretation of study results,including retinal vascular
`occlusion, retinal detachment, macular hole, or CNV of any
`cause(e.g., AMD, ocular histoplasmosis, or pathologic
`myopia)
`Concurrent disease in the study eye that would
`compromise VAor require medical or surgical intervention
`during the study period
`Cataract surgery in the study eye within 3 months,yttrium-
`aluminum-garnet (YAG) laser capsulotomywithin the past
`2 months,or any otherintraocular surgery within the 90
`days preceding Day 0
`Aphakia or absenceofthe posterior capsule in the study
`eye
`Uncontrolled glaucomaorpreviousfiltration surgery in the
`study eye
`Spherical equivalent of the refractive error in the study eye
`of more than - 8 diopters myopia
`Evidence at examination of infectious blepharitis, keratitis,
`scleritis, or conjunctivitis in either eye or current treatment
`for serious systemic infection
`Uncontrolled blood pressure
`History of cerebral vascular accident or myocardial
`infarction within 3 monthsprior to Day 0
`Uncontrolled diabetes mellitus
`Renalfailure requiring dialysis or renal transplant
`Participation in an investigational trial within 30 days prior
`to screening that involved treatment with any drug
`(excluding vitamins and minerals) or device
`History of other disease, metabolic dysfunction, physical
`examinationfinding,or clinical laboratory finding giving
`reasonable suspicion of a disease or condition that
`contraindicates the use aninvestigational drug, might
`affect interpretation of the results of the study, or renders
`the subject at high risk from treatment complications
`Pregnancyorlactation
`History ofallergy to fluorescein
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`10/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 10
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`e History ofallergy to ranibizumabinjection or related
`molecule
`
`Contacts/Locations
`
`Central Contact Person
`
`Study Officials
`
`« Name
`Jason Ehrlich, M.D., Ph.D.
`
`Role
`Study Director
`
`Affiliation
`Genentech,Inc.
`
`Location
`
`
`
`IPD Sharing
`
`Available IPD/Information
`
`IPD information
`
`
`
`References
`
`Citations
`
`(https://
`e Goldberg RA, Hill L, Davis T, Stoilov | Effectof
`pubmed
`
`lessaggressivetreatmenton diabetic
`
`retinopathy severity scale scores: analyses of the .nebi.nl
`RIDE and RISE open-label extension. BMJ Open munih.g
`Ophthalmol. 2022 Jul;7(1):e001007. doi:
`ov/3616
`10.1136/bmjophth-2022-001007.
`1830),
`
`(https:/
`e Singer M, Liu M, Schlottmann PG, Khanani AM,
`Hemphill M, Hill L, Tuomi L, Haskova Z. Predictors /pubme
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`11/14
`
`IPR2023-00884
`Samsung etal. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 11
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`-nebi.n
`of Early Diabetic RetinopathyRegression with
`Ranibizumab in the RIDE and RISE Clinical Trials. m.nih.
`Clin Ophthalmol. 2020 Jun 17;14:1629-1639. doi: gov/32
`10.2147/OPTH.S247061. eCollection 2020.
`606578
`)
`e Gonzalez VH, Wang PW, Ruiz CQ. Panretinal
`(bttps://p
`Photocoagulation for Biabetic Retinopathy inthe ubmed.n
`RIDE and RISETrials: Not "1ind Donrr
`cbi.nim.n
`Ophthalmology. 2021 Oct;128(10):1448-1457.
`ih.gov/3
`i jophtha,2019.08.010.Epub2019 1668888
`
`Aug21.
`)
`
`
`¢ Wykoff CC, Eichenbaum DA, Roth DB, HillL,Fung (https:/
`AE, Haskova Z. Ranibizumab Induces Regression /pubm
`of Diabetic Retinopathy in Most Patients atHigh
`ed.ncbi
`Risk of Progression to Proliferative Diabetic
`-nim.ni
`
`
`
`Retinopathy,Retina,2018hgov/Ophthalmol
`Oct:2(10):997-1009.doi:
`31047
`10.1016/j.oret.2018.06.005. Epub 2018 Aug_1.
`503)
`
`
`
`
`
`NeededOpen-LabelRanibizumab:
`
`e Sun JK, WangPW,Taylor S, Haskova Z. Durability (https://
`of Diabetic RetinopathyImprovement with As- a
`
`ExtensionofRIDE and RISE Studies. Ophthalmology. 2019 m.natin!g
`
`ov/3041
`May;126(5):712-720. doi:
`10.1016/j.ophtha.2018.10.041. Epub 2018 Nov 9. 9298)
`
`¢ ReddyRK, PieramiciDJ,GuneS,GhanekarA,LuN,(https:/
`
`Quezada-RuizC,BaumalCR.Efficacy of Zpubme
`
`d.ncbi,
`Ranibizumab inEveswithDiabeticMacular
`
`nim.nih
`Edema
`and Macular Nonperfusion in RIDE and
`RISE. Ophthalmology. 2018 Oct;125(10):1568-—.gov/29
`1574. doi: 10.1016/j.ophtha.2018.04.002. Epub
`752001
`2018 May8.
`)
`
`(bttps://
`° MoshfeghiAA,ShapiroH,LemmonLA,Gunes.
`
`ImpactofCataractSurgeryduringTreatment pubmed.
`with Ranibizumab in Patients with Diabetic
`nebi.nim
`Maculat Fema. Ophthalmol Retina. cus
`-nih.gov/
`a.Z a 27.
`0)
`
`
`Singh RP. Habbu K, Ehlers JP Lansang MC, Hill L, (https://
`Stoilov |. The ImpactofSystemic Factors on
`pubmed
`Clinical Response to Ranibizumab for Diabetic
`.ncbi.nl
`Macular Edema. Ophthalmology. 2016
`m.nih.go
`Jul;123(7):1581-7.doi:
`v/27234
`10.1016/j.ophtha.2016.03.038. Epub 2016 May 930)
`24.
`
`e Pieramici DJ, Wang
`
`PW, Ding B
`
`_ Visual
`
`(https:/
`
`and Anatomic Outcomesin Patients with Diabetic /pubme
`
`d.ncbi.n
`Macular Edemawith Limited Initial Anatomic
`Im.nih.
`Response to Ranibizumab in RIDE and RISE.
`Ophthalmology,2016Jun'123(6):1345-50,doi; gov/26
`10.1016/j.ophtha.2016.02.007. Epub 2016 Mar
`992841
`15.
`)
`
`e Bressler NM, Varma R, Mitchell P Suner lJ, Dolan C, (https:
`Ward J, Ferreira A, Ehrlich JS,Turpcu A. Effectof
`//pub
`
`https://clinicaltrials.gov/study/NCT004733307?tab=history&a=9
`
`12/14
`
`IPR2023-00884
`Samsung etal. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 12
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`med.n
`Ranibizumab
`on the Decision to Drive
`and Vision
`cbi.nl
`Function Relevant to Driving in Patients With
`ma.nih.
`Diabetic Macular Edema: Report From RESTORE,
`gov/2
`RIDE,
`and RISE Trials.
`JAMA
`Ophthalmol. 201
`65844
`Feb12542):160°5,dol.
`50)
`10.1001/jamaophthalmol.2015.4636.
`(https:
`Boyer DS, Nguyen QD, Brown DM, Basu kK, Ehrlich
`JS; RIDE and RISE Research Group. Outcomes with //pub
`As-Needed RanibizumabafterInitial Monthly
`med.n
`RIDE eneRISE Trials. Ophthalmology. 2015
`m.nih.
`
`
`Therapy:Long-TermOutcomesofthePhaselll§cbinl
`
`Dec;122(12):2504-13.e1.doi:
`10.1016/j.ophtha.2015.08.006. Epub 2015 Oct 9.
`
`gov/26
`45271
`3),
`
`Bansal AS, Khurana RN, Wieland MR, Wang PW,=(https:
`
`VanEverenSA,TuomiL.InfluenceofGlycosylated//pubm
`Hemoglobin on the Efficacy of Ranibizumabfor
`ed.necbi
`Diabetic Macular Edema: A Post Hoc Analysis of
`.nim.ni
`the RIDE/RISETrials. Ophthalmology. 2015
`hgov/
`Aug;122(8):1573-9.doi:
`10.1016/j.ophtha.2015.04.029. Epub 2015 Jun 4. 541)
`
`Bressler NM, Varma R, Suner IJ, Dolan CM, Ward J, (https:
`Ehrlich JS, Colman S,Turpcu A; RIDE and RISE
`pub
`Research Groups. Vision-rel
`function
`r
`med.n
`ranibizumab treatment for diabetic macular
`cbi.nl
`edema: results from RIDE and RISE.
`m.nih.
`Ophthalmology. 2014 Dec:121(12):2461-72. doi:
` gov/25
`
`10.1016/j.ophtha.2014.07.008. Epub 2014 Aug20. a
`Campochiaro PA,Wykoff CC,Shapiro H, Rubio RG, (https:/
`Ehrlich JS. Neutralization of vascular endothelial
`/pubm
`growth factor slows progression ofretinal
`ed.ncbi
`
`nonperfusion inpatientsdiabeticmacular .nolmniwith
`
`
`edema.Ophthalmology.2014Sep.121(9):1783-9. h.gov/2
`doi: 10.1016/j.ophtha.2014.03.021. Epub 2014
`476823
`Apr 24.
`9)
`
`Brown DM,Nguyen QD, Marcus DM,Boyer DS, Patel
`S, Feiner L, Schlottmann PG, Rundle AC, Zhang J,
`Rubio RG, Adamis AP Ehrlich JS,Hopkins JJ;RIDE
`
`(http
`s//p
`ubme
`
`d.ncb
`and RISE Research Groua Lono-tem euteamas of
`the 36-month results from twoohvase i tials:“RISE nih.g
`inim.
`ranibizumab therapy f
`
`and RIDE. Ophthalmology. 2013 Oct;120(10):2013- ov/2
`22. doi: 10.1016/j.ophtha.2013.02.034. Epub 2013
`3706
`May22.
`949)
`
`(https://p
`Ip MS, Domalpally A, Hopkins JJ, Wong P.
`
`
`EhrlichJS.Long-termeffectsofranibizumab on ubmed.n
`
`
`
`diabeticseverityandretinopathy progression.
`cbi.nim.ni
`ArchOphthalmol.2012Sep;130(9):1145-52.doi: h.gov/22
`10.1001/archophthalmol.2012.1043,
`265590),
`
`Links
`
`https://clinicaltrials.gov/study/NCT004733307?tab=history&a=9
`
`13/14
`
`IPR2023-00884
`Samsung etal. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 13
`
`

`

`12/14/23, 3:12 PM
`
`Record History | ver. 9: 2010-11-11 | NCT00473330| ClinicalTrials.gov
`
`DocumentSection
`
`https://clinicaltrials.gov/study/NCT00473330?tab=history&a=9
`
`14/14
`
`IPR2023-00884
`Samsung et al. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2109
`Page 14
`
`