Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial - Full Text View - ClinicalTrials.gov
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`Comparison of Age-related Macular Degeneration Treatments Trials _Lucentis-Avastin Trial
`
`A
`
`details.
`The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not meanit has been evaluated by the U.S. Federal Government. Read our disclaimer for
`
`ClinicalTrials.gov identifier: NCTO0593450
`
`RecruitmentStatus@ Completed
`First Posted @ January 15, 2008
`Results First Posted @ August30, 2012
`Last Update Posted @ August21, 2017
`
`View this study on Beta.ClinicalTrials.gov
`
`Information provided by (Responsible Party):
`University of Pennsylvania
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`{jj How to Read a Study Record
`
`Study Description Goto [+}
`
`Brief Summary
`The purpose of the study is to evaluate therelative efficacy and safety of treatment of neovascularAMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.
`A five yearfollow-upvisit is being conducted in 2014 to gather information on long term outcomes.
`
`Conaition ordisease @
`Age Related Macular Degeneration
`
`interventionftreatment ©
`Drug ranibizumab
`Drug bevacizumab
`
`Phase
`Phase 3
`
`Detailed Description
`Age related macular degeneration (AMD)is the leading cause of severe vision loss in people over the age of 65 in the United States and other Westem countries. More than 1.6 million people in the US currently have one or both eyes
`affected by the advanced stage ofAMD.
`Lucentis® is the most effective treatment for neovascularAMDstudied to date. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several
`investigators began evaluating intravitreal Avastin® for the treatment of CNV. Given its molecular similarity to Lucentis,its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative
`to Lucentis®.
`In addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has thepotential to reduce the treatment
`burden to patients as well as to reduce the overall cost of therapy.
`Only a single eye in each patient was analyzed.
`Atthe five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however,the five year follow-up visit deos not involve any study treatment.
`Study Design
`
`Go to
`
`Interventional (Clinical Trial)
`Study Type @:
`1208 participants
`Actual Enroliment @:
`Allocation: Randomized
`Intervention Model: Parallel Assignment
`Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose: Treatment
`Official Title: Comparison ofAge-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
`Actual Study Start Date @: February 2008
`
`ActualPrimaryCompletionDate@: December 2010
`
`ActualStudyCompletionDate@: April 2015
`
`(xem
`Resource links provided by the National Library of Medicine
`
`MedlinePlus Genetics related topics:Age-relateddegenerationmacular
`
`MedlinePlus related topics: Macular Degeneration
`Drug Information available for: Bevaczumab Ranibizumab
`
`US.FDAResources
`
`https://clinicaltrials.gov/ct2/show/NCT00593450
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`
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`1/5
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`Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial - Full Text View - ClinicalTrials.gov
`3/13/23, 8:48 PM
`Amo interventiontireateent©
`
`Active Comparator 1
`Drug ranibizumab
`Lucentis® on a fixed schedule of every 4 weeks for 1 year: at 1 year, re-randomization to Lucentis® every 4 weeks
`= 0.5 mg (0.05 mLintravitreal injection
`or to variable dosing.
`Other Name:Lucentis
`
`Experimental 2
`Avastin® on a fixed schedule of every 4 weeks for 1 year, at 1 year, re-randomization to Avastin® every 4 weeks or
`to variable dosing.
`
`Drug bevacizumab
`+ 1.25 mg (0.05 mLintravitreal injection
`Other Name: Avastin
`
`Experimental 3
`Lucentis® on a variable dosing schedule for 2 years; i.e.. after initial treatment, monthly evaluation for treatment
`based on signs of lesion activity.
`
`Drug ranibizumab
`+ 0.5 mg (0.05 mLintravitreal injection
`Other Name: Lucentis
`
`Experimental 4
`Avastin® on a variable dosing schedule for 2 years: Le., after initial treatment, monthly evaluation for treatment
`based on signs of lesion activity.
`
`Drug bevacizumab
`= 1.25 mg (0.05 mL)intravitreal injection
`Other Name:Avastin
`
`
`Outcome Measures Goto|~
`
`
`PrimaryOutcomeMeasures@
`1. Change From Baseline in Visual-acuity Score (Continuous)[ Time Frame: Baseline and 1 Year ]
`Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and
`the VA score at baseline.
`In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.
`
`Secondary Quicome Measures@
`1. Change From Baseline Visual-acuity Score (Frequency) [ Time Frame: Baseline and 1 Year ]
`2. Visual-acuity Score and Snellen Equivalent (Frequency) [ Time Frame:at 1 Year]
`3. Visual-acuity Score and Snellen Equivalent (Continuous) [ Time Frame:at 1 Year ]
`Visual acuity testing was performed with the Electronic Visual Tester (EVA)following the ETDRS protocol. VA score is measured as number of letters read correctly.
`In this study, the outcome VAscore is ranged from 0 to 97, with the higher score the better visual acuity.
`
`4. Number of Treatments [ Time Frame: 1 Year ]
`Cumulative over the 1 year of trial
`
`5. Average Cost of Drug/Patient [ Time Frame:at 1 Year ]
`6. Total Thickness at Fovea [ Time Frame: at 1 Year]
`7. Total Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ]
`8. Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea [ Time Frame: at 1 Year ]
`9. Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year]
`10. Fluid on Optical Coherence Tomography [ Time Frame:at 1 Year ]
`11. Dye Leakage on Angiogram [ Time Frame:at 1 Year ]
`12. Area of Lesion [ Time Frame:at 1 Year]
`13. Area of Lesion Change From Baseline [ Time Frame: Baseline and 1 Year ]
`14. Change in Systolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year]
`15. Change in Diastolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ]
`
`Eligibility Criteria
`Goto [+}
`
`Information from the National Library of Medicine
`hs
`Choosing toparticipate in a study is an importantpersonal decision. Talk with yourdoctor and family members or friends aboutdeciding tojoin a study. To leam more about this study, you or
`your doctormay contact the study research staffusing the contacts provided below. Forgeneralinformation, Learn About Clinical Studies.
`
`(Adult, OlderAdult)
`
`Ages Eligible for Study:
`Sexes Eligible for Study:
`Accepts Healthy Volunteers:
`
`50 Years and older
`All
`No
`
`Criteria
`Inclusion Criteria:
`* Active, subfoveal choroidal neovascularization (CNV)
`« Fibrosis < 50% of total lesion area
`* Visual acuity (VA) 20/25-20/320
`© Age 250 yrs
`« Atleast 1 drusen (>63y)in either eye or late AMD in fellow eye
`Exclusion Criteria:
`* Previous treatment for CNV in study eye
`* Other progressive retinal disease likely to compromise VA
`« Contraindications to injections with Lucentis orAvastin
`
`Contacts and Locations
`
`https://clinicaltrials.gov/ct2/show/NCT00593450
`
`
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`2/5
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`3/13/23, 8:48 PM
`
`Comparisonof Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial - Full Text View - ClinicalTrials.gov
`
`Information from the National Library of Medicine
`To learn more about this study, you oryour doctor may contact the study research staffusing the contactinformation providedby the sponsor.
`Please refer to this studybyits ClinicalTrials.gov identifier (NCTnumber): NCT00593450
`
`[NIH
`
`Locations
`
`> Show 59 study locations
`Sponsors and Collaborators
`University of Pennsylvania
`National Eye Institute (NE!)
`Investigatore
`Study Chair:
`Study Chair:
`Study Director:
`Study Director:
`Principal Investigator:
`
`The Cleveland Clinic
`Danie! F Martin, MD
`StudyVice-Chair, University of Pennsylvania
`Stuart L Fine, MD
`Maureen G Maguire. PhD Director of Coordinating Center, University of Pennsylvania
`Glenn Jaffe,, MD
`Director of OCT Reading Center, Duke University
`Juan E Grunwald, MD
`Principal Investigator of Photography Reading Center, Universisty of Pennsylvania
`
`More Information Goto[+}
`
`Additional information:
`
`Click here for more information about this study: Comparison ofAMD Treatments Trials (CATT) =i!
`NEIClinical Studies Database om
`
`Publications of Results:
`
`CATT Research Group; Martin DF. Maguire MG.Ying GS. Grunwald JE, Fine SL. Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19:364{20):1897-008. doi:
`10.1056/NEJMoa1102673_ Epub 2011 Apr 28.
`
`
`
`Macular,
`
`hon
`
`Treatments Trials.
`
`. Optical
`CS, Bums R, Jaffe GJ; CATT Research Gi
`Stinnett SS, H:
`DeCroos FC, Toth
`28.
`5119(12):2549-57_ doi: 10.1016.
`.2012.06.040. Epub
`2012
`fe]
`- 2012
`lictors for one-year
`. Baseline
`Degeneration Treatments Trials Research Gi
`Macular
`ire MG, Jaffe GJ, Grunwald JE, Toth C, Daniel E, Klein M, Pieramici D, Wells J, Martin DE; Comparison of
`GS, H
`Ying
`J
`
`Hagstrom SA, Ying GS, Paver GJT, SturgiltShort GM, Huang J, Callanan DG,Kim IK, Klein ML, Maguire MG, Martin DF; Comparison of AMD Treatments Trials Research Group. Pharmacogenetics for genes associated with age-related
`
`
`
`
`ration in the Comy of AMD Treatments Trials (CATT). Imology. 2013 Mar-120(3):593-599. dot 10.1016).ophtha.2012.11.037_macular Epub 2013 Jan 18.
`Jaffe GJ, Martin DE, Toth CA, Daniel E,
`ire MG,
`Ying
`GS, Grunwald JE,
`J;
`rison of
`Age-related Macular Degeneration Treatments Trials Research Group. Macular mi
`Huang
`
`:i :1860-70_ doi: 10.101
`
`Maguire MG,Daniel E, Shah AR, Grunwald JE, Hagstrom SA, Avery RL, Huang J, Martin RW, Roth DB, Castellarin AA, Bakri SJ, Fine SL, Martin DF; Comparison ofAge-Related Macular Degeneration Treatments Trials (CATT Research
`
`
`
`Gi _ Incidence of choroidal neovascularization in the felloweyein the comparison of macular neration treatments trials- mo! 2013 Oct,120(10):2035-41_ doi: 10.1016). .2013.03.017. Epub 2013 May 22.
`
`
`
`
`
`
`
`
`
`coherence
`
`rey
`
`ility
`
`during
`
`the Comparison of
`
`and visual
`
`acuity
`
`in the comparison of
`
` 10.1016/).ajo.2014.04.004.
`
`Epub 2014
`ire MG, Toth CA: Cor
`GS,
`Ying
`Jaffe GJ,
`ration treatments trials. Ophthalm:
`2014
`
`FA,
`macular
`
`ison
`
`ion Treatments Trials Research Group. Comparison
`Related Macular Di
`of
`121(10)-1956-65_ dot 10.1016/Lophtha.201404020.
`ib 2014 May 15.
`
`of optical
`
`coherence tom:
`
`assessments in the comparison of
`
`Ying GS, Kim BJ. Maguire MG. Huang J. Daniel E. Jaffe GJ. Grunwald JE, Blinder KJ. Flaxel CJ, Rahhal F. Regillo C. Martin DF: CATT Research Group. Sustained visual acuity loss in the comparison of age-related macular degeneration
`treatments trials. JAMA Ophthalmol. 2014
`Aug:132(8):015-21. doi: 10.1001/jama
`.2014.1019.
`
` 121(12)-2423-31_ doi: 10.1016).
`
`.2014-06.013. Epub
`
`2014 Jul 23.
`
`Moja L, Lucenteforte E, Kwag KH, Bertele V_ Campomori A, Chakravarthy U, D'Amico R, Dickersin K, Kodgikian L, Lindsley K, Loke Y, Maguire M, Martin DF, Mugelli A, Muhibauer B, Puntmann |, Reeves 8, Rogers C, Schmucker C.
`
`
`
`
`
`
`ic of bevacizumab versus ranibizumab for neovascular macular ation. Cochrane Database Syst Rev. 2014Subramanian ML, Virgili G_ 15;9(9)-CD011230_ dot 10.1002/14651858.CD011230|
`Altaweel MM, Daniel E, Martin DF, Mittra
`Grunwald JE, Lai MM, Melamud A, Morse LS, Hi
`J, Ferris FL 3rd, Fine SL, Maguire MG; Co!
`ison
`of
`Age-related Macular
`neration Treatments Trials (CATT) Research Gi
`;
`Comparison of
`Age-related Macular
`neration Treatments Trials CATT Research
`). Outcomes of
`with lesions com
`of >50% blood in the Comparison
`of
`Macular D:
`ion Treatments Trials (CATT).
`
`2015.
`
` treatments trials. Ophthalm
`
`
`122(4)-809-16_ dot 10.1016), ophtha.201411.007.
`
`Epub 2014 Dec 24.
`
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`3/13/23, 8:48 PM
`
`Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial - Full Text View - ClinicalTrials.gov
`
`Toth CA, Decroos FC, Ying GS, Stinnett SS, Heydary CS, Burns R, Maguire M, Martin D, Jaffe GJ. IDENTIFICATION OF FLUID ON OPTICAL COHERENCE TOMOGRAPHY BY TREATING OPHTHALMOLOGISTS VERSUS A READING
`CENTER IN THE COMPARISON OF AGE-RELATED MACULAR DEGENERATION TREATMENTS TRIALS. Retina. 2015 Jul;35(7):1303-14. doi: 10.1097/IAE.0000000000000483.
`
`Ciulla TA, Ying GS, Maguire MG, Martin DF, Jaffe GJ, Grunwald JE, Daniel E, Toth CA; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Influence of the Vitreomacular Interface on Treatment Outcomes
`in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2015 Jun;122(6):1203-11. doi: 10.1016/j.ophtha.2015.02.031. Epub 2015 Mar 29. Erratum In: Ophthalmology. 2015 Aug;122(8):1733. Cuilla,
`Thomas A [Corrected to Ciulla, Thomas A].
`
`Hagstrom SA, Ying GS, Maguire MG, Martin DF; CATT Research Group; Gibson J, Lotery A, Chakravarthy U; IVAN Study Investigators. VEGFR2 Gene Polymorphisms and Response to Anti-Vascular Endothelial Growth Factor Therapy in
`Age-Related Macular Degeneration. Ophthalmology. 2015 Aug;122(8):1563-8. doi: 10.1016/j.ophtha.2015.04.024. Epub 2015 May 28.
`
`Willoughby AS, Ying GS, Toth CA, Maguire MG, Burns RE, Grunwald JE, Daniel E, Jaffe GJ; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Subretinal Hyperreflective Material in the Comparison of
`Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2015 Sep;122(9):1846-53.e5. doi: 10.1016/j.ophtha.2015.05.042. Epub 2015 Jul 2.
`
`Ying GS, Maguire MG, Daniel E, Ferris FL, Jaffe GJ, Grunwald JE, Toth CA, Huang J, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group. Association of Baseline Characteristics and
`Early Vision Response with 2-Year Vision Outcomes in the Comparison of AMD Treatments Trials (CATT). Ophthalmology. 2015 Dec;122(12):2523-31.e1. doi: 10.1016/j.ophtha.2015.08.015. Epub 2015 Sep 15.
`
`Ying GS, Maguire MG, Daniel E, Grunwald JE, Ahmed O, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Association between Antiplatelet or Anticoagulant Drugs and Retinal or Subretinal
`Hemorrhage in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016 Feb;123(2):352-360. doi: 10.1016/j.ophtha.2015.09.046. Epub 2015 Nov 4.
`
`Daniel E, Shaffer J, Ying GS, Grunwald JE, Martin DF, Jaffe GJ, Maguire MG; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group. Outcomes in Eyes with Retinal Angiomatous Proliferation in the
`Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Ophthalmology. 2016 Mar;123(3):609-16. doi: 10.1016/j.ophtha.2015.10.034. Epub 2015 Dec 8.
`
`Shah N, Maguire MG, Martin DF, Shaffer J, Ying GS, Grunwald JE, Toth CA, Jaffe GJ, Daniel E; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Angiographic Cystoid Macular Edema and Outcomes in
`the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016 Apr;123(4):858-64. doi: 10.1016/j.ophtha.2015.11.030. Epub 2016 Jan 8.
`
`Sharma S, Toth CA, Daniel E, Grunwald JE, Maguire MG, Ying GS, Huang J, Martin DF, Jaffe GJ; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Macular Morphology and Visual Acuity in the Second
`Year of the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016 Apr;123(4):865-75. doi: 10.1016/j.ophtha.2015.12.002. Epub 2016 Jan 9.
`
`Zhou Q, Daniel E, Maguire MG, Grunwald JE, Martin ER, Martin DF, Ying GS; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Pseudodrusen and Incidence of Late Age-Related Macular Degeneration
`in Fellow Eyes in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016 Jul;123(7):1530-40. doi: 10.1016/j.ophtha.2016.02.043. Epub 2016 Apr 1.
`
`Maguire MG, Ying GS, Jaffe GJ, Toth CA, Daniel E, Grunwald J, Martin DF, Hagstrom SA; CATT Research Group. Single-Nucleotide Polymorphisms Associated With Age-Related Macular Degeneration and Lesion Phenotypes in the
`Comparison of Age-Related Macular Degeneration Treatments Trials. JAMA Ophthalmol. 2016 Jun 1;134(6):674-81. doi: 10.1001/jamaophthalmol.2016.0669.
`
`Other Publications:
`
`Martin DF, Maguire MG, Fine SL. Identifying and eliminating the roadblocks to comparative-effectiveness research. N Engl J Med. 2010 Jul 8;363(2):105-7. doi: 10.1056/NEJMp1001201. Epub 2010 Jun 2. No abstract available.
`
`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`Core JQ, Hua P, Daniel E, Grunwald JE, Jaffe G, Maguire MG, Ying GS; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Thiazolidinedione use and retinal fluid in the comparison of age-related
`macular degeneration treatments trials. Br J Ophthalmol. 2022 Apr 15:bjophthalmol-2021-320665. doi: 10.1136/bjophthalmol-2021-320665. Online ahead of print.
`
`Core JQ, Pistilli M, Hua P, Daniel E, Grunwald JE, Toth CA, Jaffe GJ, Martin DF, Maguire MG, Ying GS; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Predominantly Persistent Intraretinal Fluid
`in the Comparison of Age-related Macular Degeneration Treatments Trials. Ophthalmol Retina. 2022 Sep;6(9):771-785. doi: 10.1016/j.oret.2022.03.024. Epub 2022 Apr 9.
`
`Kolomeyer AM, Smith E, Daniel E, Ying GS, Pan W, Pistilli M, Grunwald J, Maguire MG, Kim BJ; CATT Research Group. BETA-PERIPAPILLARY ATROPHY AND GEOGRAPHIC ATROPHY IN THE COMPARISON OF AGE-RELATED
`MACULAR DEGENERATION TREATMENTS TRIALS. Retina. 2021 Jan 1;41(1):125-134. doi: 10.1097/IAE.0000000000002825.
`
`Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May
`5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
`
`Daniel E, Maguire MG, Grunwald JE, Toth CA, Jaffe GJ, Martin DF, Ying GS; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Incidence and Progression of Nongeographic Atrophy in the Comparison of
`Age-Related Macular Degeneration Treatments Trials (CATT) Clinical Trial. JAMA Ophthalmol. 2020 May 1;138(5):510-518. doi: 10.1001/jamaophthalmol.2020.0437.
`
`Ramakrishnan MS, Yu Y, VanderBeek BL. Association of Visit Adherence and Visual Acuity in Patients With Neovascular Age-Related Macular Degeneration: Secondary Analysis of the Comparison of Age-Related Macular Degeneration
`Treatment Trial. JAMA Ophthalmol. 2020 Mar 1;138(3):237-242. doi: 10.1001/jamaophthalmol.2019.4577.
`
`Scoles D, Ying GS, Pan W, Hua P, Grunwald JE, Daniel E, Jaffe GJ, Toth CA, Martin DF, Maguire MG; Comparison of AMD Treatments Trials Research Group. Characteristics of Eyes With Good Visual Acuity at 5 Years After Initiation of
`Treatment for Age-Related Macular Degeneration but Not Receiving Treatment From Years 3 to 5: Post Hoc Analysis of the CATT Randomized Clinical Trial. JAMA Ophthalmol. 2020 Mar 1;138(3):276-284. doi:
`10.1001/jamaophthalmol.2019.5831.
`
`Bavinger JC, Ying GS, Daniel E, Grunwald JE, Maguire MG; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Association Between Cilioretinal Arteries and Advanced Age-Related Macular Degeneration:
`Secondary Analysis of the Comparison of Age-Related Macular Degeneration Treatment Trials (CATT). JAMA Ophthalmol. 2019 Nov 1;137(11):1306-1311. doi: 10.1001/jamaophthalmol.2019.3509.
`
`Toth CA, Tai V, Pistilli M, Chiu SJ, Winter KP, Daniel E, Grunwald JE, Jaffe GJ, Martin DF, Ying GS, Farsiu S, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Distribution of OCT Features
`within Areas of Macular Atrophy or Scar after 2 Years of Anti-VEGF Treatment for Neovascular AMD in CATT. Ophthalmol Retina. 2019 Apr;3(4):316-325. doi: 10.1016/j.oret.2018.11.011. Epub 2018 Dec 3.
`
`Daniel E, Ying GS, Kim BJ, Toth CA, Ferris F 3rd, Martin DF, Grunwald JE, Jaffe GJ, Dunaief JL, Pan W, Maguire MG; Comparison of Age-Related Macular Degeneration Treatments Trials. Five-Year Follow-up of Nonfibrotic Scars in the
`Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2019 May;126(5):743-751. doi: 10.1016/j.ophtha.2018.11.020. Epub 2018 Nov 23.
`
`Jaffe GJ, Ying GS, Toth CA, Daniel E, Grunwald JE, Martin DF, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Macular Morphology and Visual Acuity in Year Five of the Comparison of
`Age-related Macular Degeneration Treatments Trials. Ophthalmology. 2019 Feb;126(2):252-260. doi: 10.1016/j.ophtha.2018.08.035. Epub 2018 Sep 3.
`
`Daniel E, Pan W, Ying GS, Kim BJ, Grunwald JE, Ferris FL 3rd, Jaffe GJ, Toth CA, Martin DF, Fine SL, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials. Development and Course of Scars in the Comparison
`of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2018 Jul;125(7):1037-1046. doi: 10.1016/j.ophtha.2018.01.004. Epub 2018 Feb 14.
`
`Grunwald JE, Pistilli M, Daniel E, Ying GS, Pan W, Jaffe GJ, Toth CA, Hagstrom SA, Maguire MG, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Incidence and Growth of Geographic
`Atrophy during 5 Years of Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2017 Jan;124(1):97-104. doi: 10.1016/j.ophtha.2016.09.012. Epub 2016 Oct 27.
`
`Responsible Party:
`ClinicalTrials.gov Identifier:
`Other Study ID Numbers:
`
`First Posted:
`Results First Posted:
`Last Update Posted:
`Last Verified:
`
`University of Pennsylvania
`NCT00593450 History of Changes
`NEI-137
`U10EY017823 ( U.S. NIH Grant/Contract )
`January 15, 2008 Key Record Dates
`August 30, 2012
`August 21, 2017
`July 2017
`
`Individual Participant Data (IPD) Sharing Statement:
`Plan to Share IPD:
`Yes
`Plan Description:
`Available at https://hyperprod.cceb.med.upenn.edu/catt/catt_index.php
`
`Studies a U.S. FDA-regulated Drug Product:
`Studies a U.S. FDA-regulated Device Product:
`
`Yes
`No
`
`Keywords provided by University of Pennsylvania:
`
`https://clinicaltrials.gov/ct2/show/NCT00593450
`
`4/5
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`Samsung Bioepis Exhibit 1017 - Page 4
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`3/13/23, 8:48 PM
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`Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial - Full Text View - ClinicalTrials.gov
`
`bevacizumab
`ranibizumab
`choroidal neovascularization
`
`Additional relevant MeSH terms:
`Macular Degeneration
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`Bevacizumab
`Ranibizumab
`Antineoplastic Agents, Immunological
`
`Antineoplastic Agents
`Angiogenesis Inhibitors
`Angiogenesis Modulating Agents
`Growth Substances
`Physiological Effects of Drugs
`Growth Inhibitors
`
`https://clinicaltrials.gov/ct2/show/NCT00593450
`
`5/5
`
`Samsung Bioepis Exhibit 1017 - Page 5
`Biocon Exhibit 1017 - Page 5
`
`