Document Id: A2E14840-7752-11ED-9ABE-D9D7D5EA128C
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`AFFIDAVIT OF NATHANIEL E FRANK-WHITE
`
`1.
`
`I am a Records Request Processor at the Internet Archive. 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.
`
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). If archived records for a URL are
`available, the visitor will be presented with a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages or other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hyperlink’s URL with the
`closest available date to the initial file containing the hyperlink.
`
`4. The archived data made viewable and browsable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`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). 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 images, audio, multimedia, design
`elements, or other embedded content) linked within that primary HTML file, the
`primary HTML file and the other files will each have their own respective extended
`URLs and may not have been archived on the same dates.
`
`6. Attached hereto as Exhibit B are true and accurate copies of the Internet Archive's
`records of the archived files for the URLs and the dates specified in the attached
`coversheet of each file.
`
`Celltrion Exhibit 1020
`Page 1
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`

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`12/08/2022
`
`Please see attached
` All Purpose
` Jurat form
` for additional
` Notary Events
`
`Nathaniel Frank-White
`
`Document Id: A2E14840-7752-11ED-9ABE-D9D7D5EA128C
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`7.
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`I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE: ________________________
`
`________________________
`Nathaniel E Frank-White
`
`Celltrion Exhibit 1020
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`Document Id: A2E14840-7752-11ED-9ABE-D9D7D5EA128C
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`Celltrion Exhibit 1020
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`Document Id: A2E14840-7752-11ED-9ABE-D9D7D5EA128C
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`https://web.archive.org/web/20100713035617/http:/www.med.upenn.edu/cpob/studies/documents/CATTEli
`gibilityCriteria_000.pdf
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`Celltrion Exhibit 1020
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`Document Id: A2E14840-7752-11ED-9ABE-D9D7D5EA128C
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`CATT PATIENT ELIGIBILITY CRITERIA
`
`Inclusion Criteria
`All patients must meet the following criteria for entry into the CATT: Lucentis-Avastin Trial:
`
`• Signed informed consent form
`• Age ≥ 50 years of either gender
`• Women must be postmenopausal for at least 12 months prior to trial entry, or
`surgically sterile. If of child bearing potential, a serum pregnancy test with a
`negative result must be obtained within 14 days prior to the first treatment.
`Women of child bearing potential must be practicing effective contraception
`implemented during the trial and for at least 60 days following the last dose of
`study medication.
`• No condition that precludes follow-up for 2 years.
`• No contraindication to intravitreal injection of Lucentis® or Avastin®, as specified
`in the exclusion criteria below.
`
`Eligibility criteria for study eyes
`Study eyes must meet the following criteria for entry into the CATT: Lucentis-Avastin Trial:
`• Newly diagnosed, angiographically documented, previously untreated, active
`CNV
`lesion (i.e.,
`leakage on fluorescein angiography AND subretinal,
`intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular
`degeneration.
`• Best corrected visual acuity in the study eye, using e-ETDRS testing, between
`20/25 and 20/320 (Snellen equivalent), inclusive.
`Only one eye will be enrolled in the Study. If both eyes are eligible,
`the patient and study ophthalmologist will select the eye for entry.
`
`• The CNV or sequela of the CNV (i.e., pigment epithelium detachment, subretinal
`or sub-RPE hemorrhage, blocked fluorescence, macular edema, or subretinal sub-
`RPE or intraretinal fluid) must involve the center of the fovea.
`• The total area of fibrosis must comprise less than 50% of the total lesion.
`• ≥ 1 drusen (>63 microns) in either eye OR late AMD in fellow eye
`• No previous treatment for CNV in the study eye
`• Clear ocular media and adequate pupillary dilation to permit good quality fundus
`imaging.
`• Disc and macula color stereoscopic photographs and fluorescein angiogram
`within 7 days of randomization.
`• OCT of the macula within 7 days of randomization.
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`Celltrion Exhibit 1020
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`EXCLUSION CRITERIA
`Subjects who meet any of the following criteria will be excluded from study entry:
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`Prior/Concomitant Treatment
`• Previous treatment with verteporfin PDT, Macugen®, Lucentis®, intravitreal
`Avastin®, thermal laser, external beam radiation or other AMD therapy in the study
`eye. Prophylactic treatment such as CAPT/CNVPT treatment does not exclude the
`patient.
`• Previous treatment with intravenous Avastin®
`• Concurrent treatment with an investigational drug or device in the non-study eye for
`any ocular condition
`• History of submacular surgery or other surgical intervention for AMD in the study
`eye
`• Previous participation in any studies of investigational drugs likely to have ocular
`effects within 30 days preceding the initial study treatment
`• Concurrent use of systemic anti-VEGF agents.
`
`Exclusionary Lesion Characteristics
`• Fibrosis or geographic atrophy involving the center of the fovea in the study eye
`• CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
`pathologic myopia
`• Retinal pigment epithelial tear involving the macula in the study eye
`
`•
`
`Exclusionary Concurrent Ocular Conditions
`Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic
`retinopathy) that, in the opinion of the investigator, could either require medical or
`surgical intervention during the 2 year follow-up period to prevent or treat visual
`loss that might result from that condition, or, if allowed to progress untreated, could
`likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual
`acuity over the 2 year follow-up period.
`• Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in
`the study eye
`• Current vitreous hemorrhage in the study eye
`• History of rhegmatogenous retinal detachment or macular hole in the study eye
`• History of vitrectomy in the study eye
`• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
`• Spherical equivalent of the refractive error in the study eye demonstrating more
`than 8 diopters of myopia
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`•
`
`• For subjects who have undergone prior refractive or cataract surgery in the study
`eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of
`myopia.
`Intraocular surgery (including cataract surgery) in the study eye within 2 months
`preceding the first study treatment.
`• Uncontrolled glaucoma in the study eye (defined as intraocular pressure >25 mmHg
`despite treatment with antiglaucoma medication)
`• Patients who are unable to be photographed to document CNV due to known
`allergy to fluorescein dye, lack of venous access or cataract obscuring the CNV.
`• Patients with other progressive retinal disease likely to affect visual acuity within
`the next 2 years. Patients with pattern dystrophy with CNV and drusen determined
`to be definitely AMD are eligible.
`• Patients with other ocular diseases that can compromise the visual acuity of the
`study eye such as amblyopia and anterior ischemic optic neuropathy
`
`Concurrent Systemic Conditions
`• Premenopausal women not using adequate contraception (see Section 3.3)
`• Pregnancy or lactation
`• History of other disease, metabolic dysfunction, physical examination finding, or
`clinical laboratory finding giving reasonable suspicion of a disease or condition that
`contraindicates the use an investigational drug or that might affect interpretation of
`the results of the study or render the subject at high risk for treatment complications
`• Current treatment for active systemic infection
`• Evidence of significant uncontrolled concomitant diseases such as cardiovascular
`disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal
`disorders
`• History of recurrent significant infections or bacterial infections
`Inability to comply with study or follow-up procedures
`•
`
`DEFINITION OF TERMS PERTAINING TO ELIGIBILITY CRITERIA
`Informed Consent: Written informed consent must be obtained from each patient prior to
`performing any study-specific procedures. The patient should be asked to sign the consent form
`only after the patient has been introduced to the study and had questions answered.
`
`Age: Few patients below the age of 50 are anticipated to meet the criteria below. Patients below
`the age of 50 may have forms of macular degeneration other than age-related macular
`degeneration.
`
`Images: Stereoscopic color photographs of the disc and macula of both eyes are required. In
`addition, a fluorescein angiogram with the early phase on the study eye is mandatory. An OCT
`of each eye is also required. All images must be taken within 7 days prior to randomization.
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`Celltrion Exhibit 1020
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`Document Id: A2E14840-7752-11ED-9ABE-D9D7D5EA128C
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`Effective Contraception: Acceptable methods of birth control are surgical sterilization, use of
`oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with
`spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
`
`Condition Precluding Follow-Up: Patients must have a high probability of completing 2 years
`of follow-up. The mere presence of serious health conditions in this population does not
`disqualify the patient from enrollment. However, if the severity of the condition is such that
`progression to a state where travel to the clinical center for regular follow-up visits would place
`undue burden on the patient or is such that death is almost certain to occur during the follow-up
`period, the patient should not be enrolled in the study. Patients with known plans to move to an
`area of the country without a nearby CATT clinical center should not be enrolled.
`
`Contraindications to Lucentis® or Avastin® injections: No previous inflammatory reactions
`following intravitreal Lucentis® or Avastin® treatment in the non-study eye.
`
`Active CNV includes both of the following: leakage on fluorescein angiography AND subretinal
`or intraretinal fluid on OCT.
`
`CNV lesion: A contiguous area of abnormal tissue in the macula that encompasses
`angiographically documented CNV with possible additional components of subretinal
`hemorrhage, blocked fluorescence not from hemorrhage, serous detachment of the retinal
`pigment epithelium, and fibrosis.
`
`AMD: Clinical and/or angiographic signs consistent with AMD (e.g., drusen, retinal pigment
`epithelial changes, choroidal neovascularization) with no other likely etiologic explanations for
`the degenerative changes.
`
`Sequela of CNV: Sequela of the lesion includes pigment epithelial detachment, subretinal , sub-
`RPE hemorrhage, blocked fluorescence, macular edema, or subretinal, sub-RPE or intraretinal
`fluid contiguous with the CNV lesion.
`
`Visual Acuity Score: The best corrected E-ETDRS visual acuity score for a study eye must be
`> 23 letters (20/320 or better) and < 82 letters (20/25 or worse).
`
`Cataract Surgery: Eyes that have had lens extraction or lens implantation within the last 2
`months are ineligible. Eyes that have had a capsulotomy within the past 2 months are ineligible.
`
`Lens Opacities: Lens opacities may be present but must be such that at enrollment and for the
`next 2 years the view of the posterior pole for ophthalmoscopy and photography is unobstructed.
`Patients likely to undergo cataract extraction in the study eye within the next 2 years should not
`be enrolled in the Lucentis-Avastin Trial Study.
`
`Myopia: Eyes with fundus changes consistent with high myopia, such as lacquer cracks, are
`ineligible. Eyes with a spherical equivalent more negative than –8.00 diopters are ineligible even
`if there are no myopic changes apparent in the fundus.
`
`Progressive Ocular Disease: Any condition that is likely to decrease visual acuity over the
`course of 2 years excludes the patient from the study.
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