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`
`415 561 6767
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`415 840-0391 e-fax
`
`
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`Internet Archive
`
`300 Funston Avenue
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`San Francisco, CA 94118
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`_____________________
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`AFFIDAVIT OF DUNCAN HALL
`
`
`
`1. I am a Records Request Processor at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
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`
`3. The Internet Archive has created a service known as the Wayback Machine. The
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`4. The archived data made viewable and browseable by the Wayback Machine is
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`http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in
`hh:mm:ss]/[Archived URL] aka an “extended URL”. Thus, the extended URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28
`seconds (1997/01/26 at 04:58:28). A web browser may be set such that a printout
`from it will display the URL of a web page in the printout’s footer. The date
`indicated by an extended URL applies to a preserved instance of a file for a given
`URL, but not necessarily to any other files linked therein. Thus, in the case of a
`page constituted by a primary HTML file and other separate files (e.g., files with
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`have their own respective extended URLs and may not have been archived on the
`same dates.
`
`
`
`0001
`
`CELLTRION - EXHIBIT 1070
`
`

`

`
`
`6. Attached hereto as Exhibit A are true and accurate copies of printouts of
`screenshots of the Internet Archive's records of the archived files for the URLs and
`the dates specified in the attached coversheet of each printout.
`
`
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`
`
`
`
`
`
`
`DATE: ________________________
`
`
`________________________
`Duncan Hall
`
`01/20/2021
`
`0002
`
`

`

`
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`0003
`
`0003
`
`

`

`https://web.archive.org/web/20110408231012/http://clinicaltrials.gov/ct2/show/NCT0101297
`3
`
`
`
`
`0004
`
`

`

`
`
`iererner avcacve—[http://clinicaltrials.gov/ct2/show/NCTO1012973 MAR
`
`8 Apr 2011-14 Nov 2013
`
`
`<
`JE
`WAYBSCHMACHINE —scaptures
`
`ClinicalTrials.gov Home SearchStuyToples Glossary.
`
`Aservice of the U.S. National Institutes of Health
`
`
`
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion
`(CRVO) (GALILEO)
`
`This study is ongoing, but not recruiting participants.
`
`First Received on October 30, 2009. Lasi Updated on January 25, 2011 History of Changes
`
`rereSd
`
`
`
`® Purpose
`To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eyeinjected into the eye on vision function in subjects with macular edema as a consequenceofcentralretinal
`vein occlusion
`
`Intervention Retina! Vein Occlusion
`
`Drug: VEGF Trap-Eye (BAY86-5321)
`Other: Sham treatment
`
`Phase II!
`
`Study Type:_Interventional
`Study Design: Allocation: Randomized
`Endpoint Classification: Safety/Efficacy Study
`Intervention Model: Parallel Assignment
`Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
`Primary Purpose: Treatment
`
`Official Title:|A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in
`Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
`
`Resource links provided by NLM:
`
`
`Genetics Home Reference related topics: Stargardt macular degeneration X-linked juvenile retinoschisis
`
`MedlinePlusrelated topics: Edema
`
`Drug Information available for: Aflibercept
`U.S. FDA Resources
`
`Further study details as provided by Bayer:
`
`Primary Outcome Measures:
`* The proportion of subjects who gain at least 15 letters in BCVA on the EDTRSchart compared with baseline at the Week 24 endpoint [ Time Frame: Week 24 |
`[ Designated as safety issue: No }
`
`Secondary Outcome Measures:
`* Changefrom baseline in BCVA score [ Time Frame: week 24 ] [ Designated as safety issue: No }
`* Absolute change trom baseline in centralretinal thickness, assessed by OCT [ Time Frame: Week24 ] [ Designated assafety issue: No ]
`+ Proportion of subjects progressing to anterior segment neovascularization, neovascularization of the optic disc (NVD), or neovascularzation of the retina elsewhere
`(NVE)requiring pan-retinal photocoagulation [ Time Frame: Week24 | { Designated as safety issue: No }
`* Changein the NEI-VFQ-25total score from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No]
`+ Changein the EQ-5D score from baseline [ Time Frame: Week 24 } [ Designated as safety issue: No }
`
`165
`Estimated Enrollment:
`October 2009
`Study Start Date:
`Estimated Study Completion Date:=March 2012
`Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
`
`
` Arms Assigned Interventions
`Arm 1: Experimental
`Drug: VEGF Trap-Eye (BAY86-5321)
`Intervention:
`Intravitreal injection. Weeks0 to 20 injection of VEGF Trap-Eye every 4 weeks; weeks 24 to 52 every 4 weeks plus additional on week 60
`Drug: VEGF
`and 68re-assessmentand either (PRN)injection of VEGF Trap-Eye or sham injection;last visit (no treatment) at week76.
`Trap-Eye
`(BAY86-
`5321)
`Arm 2: Sham
`Comparator
`Intervention:
`Other: Sham
`
`treatment
`
`Other: Sham treatment
`Sham treatment. Weeks 0 to 20 sham treatment every 4 weeks; weeks 24 to 48 every 4 weeks re-assessment and sham injection; week
`52 VEGF Trap-Eye injection (unless investigator declines for medical reasons), weeks 60 and 68 re-assessmentandeither (PRN)
`injection of VEGF Trap-Eye or sham injection;last visit (no treatment) al week 76.
`
`0005
`
`0005
`
`

`

`&Eligibility
`AgesEligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`Inclusion Criteria:
`
`18 Years and older
`Both
`No
`
`* Center-involved macular edema secondary to central retinal vein occlusion (CRVQ)for no longer than 9 months with mean central subfield thickness >= 250 ym on optical
`coherence tomography (OCT)
`« Adults >= 18 years
`« early treatmentdiabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24letters) in the study eye
`Exclusion Criteria:
`
`« Anyprior treatment with anti-VEGF agentsin the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of
`systemic anti-angiogenic medications
`« Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
`* CRVO disease duration > 9 months from date of diagnosis
`« Previous use ofintraocular 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 preretinalfibrosis involving the macula in either the study eye orfellow eye
`
`® Contacts and Locations
`
`Pleaserefer to this study byits ClinicalTrials.gov identifier: NCT01012973
`
`4+] Show 73 Study Locations
`
`Sponsors and Collaborators
`Bayer
`Regeneron Pharmaceuticals
`
`Investigators
`Study Director: Bayer Study Director Bayer
`
`> More Information
`Additional Information:
`
`Click here and search for drug _information provided by the FDA.
`
`[Et]
`
`Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. ET)
`
`Click here to find results for studies related to marketed products, Et]
`
`No publications provided
`
`Bayer HealthCare AG ( Therapeutic Area Head )
`Responsible Party:
`ClinicalTrials.gov Identifier: NCTO1012973
`History of Changes
`Other Study ID Numbers:
`14130, EudraCT: 2009-010973-19
`Study First Received:
`October 30, 2009
`Last Updated:
`January 25, 2011
`Health Authority:
`Germany: Federal Institute for Drugs and Medical Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Agency
`for Health and Food Safety; France: Afssaps - French Health Products Safety Agency; Hungary: NationalInstitute of Pharmacy;
`Italy: Ministry of Health;
`Latvia: State Agency of Medicines;
`Japan: Pharmaceuticals and Medical Devices Agency; Singapore: Health Sciences Authority; South Korea: Korea Food
`and Drug Administration (KFDA)
`
`Keywords provided by Bayer:
`Macular Edema
`Central Retinal Vein Occlusion
`cRVO
`VEGF Trap-Eye
`best-corrected visual acuity
`Additional relevant MeSH terms:
`Macular Edema
`Retinal Vein Occlusion
`Macular Degeneration
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`Venous Thrombosis
`Thrombosis
`
`Embolism and Thrombosis
`Vascular Diseases
`Cardiovascular Diseases
`Endothelial Growth Factors
`Growth Substances
`Physiological Effects of Drugs
`Pharmacologic Actions
`
`ClinicalTrials.gov processed this record on April 07, 2011
`
`
`Contact Help Desk
`Lister Hill National Genter for Biomedical Communications, U.S. National Library of Medicine,
`U.S. National Institutes of Health, U.S. Department of Health & Human Services,
`USA.gov, Copyright, Privacy, Accessibility, Freedom ot Information Act
`
`iaG
`ee.Ue
`Ses? INANE LpWS. Deparment of Health & Human Services
`
`0006
`
`0006
`
`

`

`https://web.archive.org/web/20090813064936/https://clinicaltrials.gov/ct2/show/NCT006373
`77
`
`
`
`
`0007
`
`

`

`
`
`ioteener arcarye—[https://clinicaltrials.gov/ct2/show/NCT00637377 MAY
`
`18 jan 2009-23 jan 2017
`
`
`Waybackmachine21captures La | <
`
`ClinicalTrials.govStudyToples Glossary.Home Search
`
`
`A service of the U.S. National Institutes of Health
`II Search
`
`
`ie di at
`
`1
`
`i
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneration (AMD) (VIEW 2)
`
`This study is currently recruiting participants.
`Verified by Bayer, July 2009
`
`
`First Received: March 12,2008 Last Updated: July 3,2009 History of Changes
`
`
`
`NoTo088787
`
`® Purpose
`This study is a phaseIII, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately
`1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.
`
` Macular Degeneration
`
`Drug: VEGF Trap-Eye
`Drug: Ranibizumab
`
`Interventional
`Study Type:
`Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
`
`Official Title:|A Randomized, Double Masked,Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Dosesof Intravitreal VEGF Trap in Subjects With
`Neovascular Age-Related Macular Degeneration (AMD).
`
`Resource links provided by NLM:
`
`
`
`
`
`
`
`GeneticsHomeReferencerelated topics: X-linkedjuvenileretinoschisis
`
`MedlinePlus related topics: Macular Degeneration
`
`Drug Information available for: Ranibizumab Aflibercept
`U.S. FDA Resources
`
`Further study details as provided by Bayer:
`
`Primary Outcome Measures:
`¢ The proportion of subjects who maintain vision at Week 52, where a subjectis classified as maintaining visionif the subject has lost fewerthan 15 letters on the ETDRS
`chart compared to baseline (ie, prevention of moderate vision loss) [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
`
`Secondary Outcome Measures:
`« Mean change from baseline in BCVAas measured by ETDRSletter score at Week 52 | Time Frame: week 52 } [ Designated as safety issue: Yes }
`* The proportion of subjects who gain at least 15 letters of vision at Week 52 | Time Frame: week 52 }[ Designated as safety issue: No}
`* Mean changefrom baseline in total NEI VFQ-25 score at Week 52 [ Time Frame: week 52 } [ Designated as safety issue: No ]
`« Mean changefrom baseline in CNV area at Week 52 [ Time Frame: week 52 } [ Designated as safety issue: Yes ]
`
`Estimated Enrollment:
`Study Start Date:
`Estimated Study Completion Date:
`Estimated Primary Completion Date:
`
`1200
`April 2008
`September 2011
`July 2011 (Final data collection date for primary outcome measure)
`
`frequently than every 12 weeks.
`
`farms|Assigned Interventions
`Arm 3:
`Drug: VEGF Trap-Eye
`Experimental
`2.0 mg VEGF Trap-Eye administered every 8 weeks(including one additional 2,0 mg dose ai Week4) during thefirst year. Thereafter a dose may be
`administered as frequently as every 4 weeks, butnoless frequently than every 12 weeks.
`
`Arm 1:
`Experimental
`
`Arm 2:
`Experimental
`
`Drug: VEGF Trap-Eye
`0.5 mg VEGF Trap-Eye administered every 4 weeks during thefirst year. Theroafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGFTrap-Eye administered every 4 weeksduringthe first year. Thereafter a dose may be administered as frequently as every 4 weeks,but
`no less frequently than every 12 weeks.
`
`Arm 4: Active
`Comparator
`
`Drug: Ranibizumab
`0.5 mg administered every 4 weeks during thefirst year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less
`
`® Eligibility
`
`0008
`
`0008
`
`

`

`AgesEligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`Inclusion Criteria:
`
`50 Years and older
`Both
`No
`
`* Signed informed consent.
`* Men and women >/=50 yearsof age.
`* Active primary or recurrent sudfoveal CNV lesions secondary to AMD,including juxtafoveal lesions that affect the fovea as evidenced by FA in the stucy eye.
`« ETDRSbest-correcied visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
`¢ Willing, committed, and able to return for ALLclinic visits and completeall study-related procedures.
`« Able to read,(or, if unable to read dueto visual impairment, be read to verbatim by the person administering the informed consentor a family member) understand and
`willing to sign the iniormed consent form.
`Exclusion Criteria:
`
`« Anyprior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD,except dietary supplements or vitamins.
`* Anyprior or concomitant therapy with another investigational agent to treat neovascular AMDin the study eye.
`¢ Anyprior teatment with anti-VEGF agents in the study eye.
`* Totallesion size >12 disc areas (30.5 mm&é#xfffd;, including blood, scars and neovascularization) as assessed by FAin the study eye.
`¢ Subretinal hemorrhagesthatis either 50% or moreof the total lesion area,orif the blood is under the fovea and is 1 or more disc areasin size in the study eye(if the blood
`is under the fovea, then the fovea must be surrounded by 270 degreesbyvisible CNV).
`¢ Scarorfibrosis making up >50% of thetotallesion in the study eye.
`* Scar,fibrosis, or atrophy involving the center of the fovea in the study eye.
`¢ Presenceof retinal pigment epithelial tears or rips involving the maculain the study eye.
`* History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
`« Presence of other causes of CNV in the study eye.
`¢ Prior vitrectomy in the study eye.
`¢ History of retinal detachmentor treatment or surgery for retinal detachmentin the study eye.
`+ Anyhistory of macular hole of stage 2 and abovein the study eye.
`¢ Anyintraocularor periocular surgery within 3 months of Day 1 on the study eye, exceptlid surgery, which may not have taken placewithin 1 month of Day1, as long asitis
`unlikely to interfere with the injection.
`+ History orclinical evidence of diabetic retinopathy, diabetic macular edemaoranyretinal vascular disease other than AMDineither eye.
`
`® Contacts and Locations
`
`Pleasereferto this study by its ClinicalTrials.gov identifier: NCT00637377
`
`Contacts
`Contact: Bayer Clinical Trials Contact_clinical-trials-contact@ bayerhealthcare.com
`
`sH Show 212 Study Locations
`Sponsors and Collaborators
`Bayer
`
`Investigators
`Study Director: Bayer Study Director Bayer
`
`® More Information
`Additional Information:
`
`Click here and searchfor drug information provided by the FDA it)
`
`
`Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product =i)
`Click here to find results
`for studies related
`to marketed pri
`
`No publications provided
`
`Bayer Schering Pharma AG ( Therapeutic Area Head )
`Responsible Party:
`91689, EurdaCT No.: 2007-000583-25
`Study ID Numbers:
`March 12, 2008
`Study First Received:
`July 3, 2009
`Last Updated:
`ClinicalTrials.govIdentifier: NCT00637377 History of Changes
`Health Authority:
`Switzerland: Ethikkommission
`
`Keywords provided by Bayer:
`Eye diseases
`Vision Impairment and Blindness
`Eyes and Vision
`
`Study placed in the following topic categories:
`Eye Diseases
`Mitogens
`Retinal Degeneration
`Macular Degeneration
`Additional relevant MeSH terms:
`Growth Substances
`Eye Diseases
`Physiological Effects of Drugs
`Retinal Degeneration
`
`Seniors
`Neovascular Age-Related Macular Degeneration (AMD)
`Retinal Disease
`
`Blindness
`Endothelial Growth Factors
`Retinal Diseases
`Vision, Low
`
`Macular Degeneration
`Endothelial Growth Factors
`Pharmacologic Actions
`Retinal Diseases
`
`ClinicalTrials.gov processed this record on August 12, 2009
`
`
`Contact Help Desk
`Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicne,
`U.S. NationalInstitutes of Health, U.S. Department ct Heath & Human Services,
`
`0009
`
`0009
`
`

`

`
`USA.gov, Gopyright, Privacy, Accessibility, Freedom of Information Act
`
`OMGos? DOM
`
`0010
`
`0010
`
`

`

`https://web.archive.org/web/20090911163626/https://clinicaltrials.gov/ct2/show/NCT005097
`95
`
`
`0011
`
`

`

`Waybackmachine21captures mi,
`
`2008
`ioteener arcarye—[https://clinicaltrials.gov/ct2/show/NCTO0509795 MAY
`
`
`<
`1
`Bee I
`|
`ClinicalTrials.gov
`ee
`
`
`Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneration(AMD) (VIEW 1)
`
`This study is currently recruiting participants.
`Verified by Regeneron Pharmaceuticals, April 2009
`
`First Received: July 31, 2007 Last Updated: April 28, 2009 History of Changes
`
`
`
`NOTOOS0979
`
`® Purpose
`This study is a phase |II, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately
`1200 patients will be randomized in the US and Canada.
`
`
`
`Drug: VEGF Trap-Eye
`Drug: Ranibizumab
`
`Macular Degeneration
`
`Study Type:_Interventional
`Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efticacy Study
`
`Official Title:|A Randomized, Double Masked, Active Controlled PhaseIII Study of the Efficacy, Safety, and Tolerability oi Repeated Dosesof Intravitreal VEGF Trap in Subjects With
`Neovascular Age-Related Macular Degeneration
`
`Resource links provided by NLM:
`
`
`Genetics Home Reference related topics: X-linked juvenile retinoschisis
`
`MedlinePlus related topics: Macular Degeneration
`
`Drug Information available for: Ranibizumab Aflibercept
`U.S. FDA Resources
`
`Furtherstudy details as provided by Regeneron Pharmaceuticals:
`
`Primary Outcome Measures:
`* The proportion of subjects who maintain vision at Week 52, where a subjectis classified as maintaining vision if the subject nas lost fewer than 15 letters on the ETDRS
`chart compared to baseline(i.e. prevention of moderatevision loss) [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
`
`Secondary Outcome Measures:
`« Mean change from baseline in BCVAas measured by ETDRSletter score at Week 52 [ Time Frame: Week 52 } [ Designated as safety issue: Yes }
`* The proportion of subjects who gain at least 15 letters of vision at Week 52 [ Time Frame: Week 52| [ Designated as safety issue: No]
`* Mean changefrom baseline in total NEI VFQ-25 score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No }
`+ Mean change from baseline in CNV area at Week 52 [ Time Frame: Week &2 ] [ Designated as safety issue: Yes]
`
`1200
`Estimated Enrollment:
`August 2007
`Study Start Date:
`Estimated Study Completion Date:|December 2011
`Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
`
`[Arms_|AssignedInterventions
`‘
`Drug: VEGF Trap-Eye
`Experimental
`0.5 mg VEGFTrap-Eye administered every 4 weeksduring the first year. Thereafter a dose may be administered as frequently as every 4 weeks,but
`no less frequently than every 12 weeks.
`
`than every 12 weeks.
`
`2:
`Experimental
`
`Drug: VEGFTrap-Eye
`2.0 mg VEGFTrap-Eye administered every 4 weeks duringthe first year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`3:
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGFTrap-Eye administered every 8 weeks (including one additional 2.0 mg dose at week 4) during the first year. Thereafter a dose may be
`administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
`
`4: Active
`Comparator
`
`Drug: Ranibizumab
`0.5 mg administered every 4 weeks during thefirst year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently
`
`0012
`
`0012
`
`

`

`® Eligibility
`
`AgesEligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`50 Years and older
`Both
`No
`
`KeyInclusion Criteria:
`=i
`. Signed Informed Consent.
`Men and women = 50 years of age.
`Active primary or recurrent sudfoveal CNV lesions secondary to AMD,including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
`ETDRSbest-correcied visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
`Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
`Ableto read, (or, if unable to read dueto visual impairmeni, be read to verbatim by the person administering the informed consentor a family member. See Appendix J.4)
`understand and willing to sign the informed consent form.
`
`oanoD
`
`aPond
`
`Key Exclusion Criteria:
`ah . Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements orvitamins.
`Any prior or concomitant therapy with another investigational agent to treat neovascular AMDin the study eye, except dietary supplementsor vitamins.
`Anyprior teatmentwith anti-VEGF agentsin the study eye.
`Total lesion size > 12 disc areas (30.5 mm2,including blood, scars and neovascularization) as assessed by FA in the study eye.
`Subretinal hemorrhagethat is either 50% or moreofthe total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye.(If the blood
`is under the fovea, then the fovea must be surrounded 270 degreesbyvisible CNV.)
`. Scarorfibrosis, making up > 50% of total lesion in the study eye.
`. Sear, fibrosis, or atrophy involving the centerof the fovea.
`8. Presenceof retinal pigmentepithelial tears or rips involving the maculain the study eye.
`9. History of any vitreous hemorrhage within 4 weeksprior to Visit 1 in the study eye.
`10. Presence of other causes of CNVin the study eye.
`11. History orclinical evidenceof diabetic retinopathy, diabetic macular edemaorany other vascular disease affecting the retina,other than AMD,in either eye.
`12. Prior vitrectomy in the study eye.
`13. History of retinal detachmentor treatmentor surgery for retinal detachmentin the study eye.
`14. Any history of macular hole of stage 2 and abovein the study eye.
`15. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, exceptlid surgery, which may not have taken place within 1 month of day1, as long asits
`unlikely to interfere with the injection.
`
`6 7
`
`® Contacts and Locations
`
`Pleasereferto this study by its ClinicalTrials.gov identifier: NCT00509795
`
`Contacts
`
`Contact Regeneron
`
`866-549-8439 VIEW41study@rtp.ppdi.com
`
`“}# Show 191 Study Locations
`Sponsors and Collaborators
`Regeneron Pharmaceuticals
`Bayer
`Investigators
`Study Director: Avner Ingerman, MD Regeneron Pharmaceuticals
`
`® MoreInformation
`
`No publications provided
`
`Regeneron Pharmaceuticals ( Dr. Avner Ingerman)
`Responsible Party:
`VGFT-OD-0605
`Study ID Numbers:
`July 31, 2007
`Study First Received:
`April 28, 2009
`Last Updated:
`
`History of Changes
`ClinicalTrials.gov Identifier: NCT00509795
`Health Authority:
`United States: Food and Drug Administration; Canada: Health Canada
`
`Study placed in the following topic categories:
`Eye Diseases
`Mitogens
`Retinal Degeneration
`Additional relevant MeSH terms:
`Growth Substances
`Eye Diseases
`Physiological Effects of Drugs
`Retinal Degeneration
`
`Macular Degeneration
`Endothelial Growth Factors
`Retinal Diseases
`
`Macular Degeneration
`Endothelial Growth Factors
`Pharmacologic Actions
`Retinal Diseases
`
`ClinicalTrials.gov processed this record on September 11, 2009
`
`
`Gontact Melp Desk
`Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicne,
`U.S. National institutes of Health, U.S. Department of Heath & Human Services,
`USAgov, Copyright, Privacy, Accessibility, Freedom ot Information Act
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`ia NLM (g
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`0013
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`0013
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`State/Commonwealthof
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`VIRGINIA
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`L_kity [¥|County of Virginia Beach )
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`Duncan D Hall
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`-- OR --
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`WilliamScott
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`COMMISSION EXPIRES
`January 31, 2024
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`William Scott
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`7897791
`Notary Commission Expires:__01/31/2024
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`DESCRIPTION OF ATTACHED DOCUMENT
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`Document Date:_01/20/2021
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`Numberof Pages(including notarial certificate):
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`14
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