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`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
`
`The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for
`details.
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`ClinicalTrials.gov Identifier: NCT00593450
`
`Recruitment Status  : Completed
`First Posted  : January 15, 2008
`Results First Posted  : August 30, 2012
`Last Update Posted  : August 21, 2017
`
`View this study on Beta.ClinicalTrials.gov
`
`Sponsor:
`University of Pennsylvania
`
`Collaborator:
`National Eye Institute (NEI)
`
`Information provided by (Responsible Party):
`University of Pennsylvania
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Brief Summary:
`
`Go to
`
`The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.
`
`A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.
`
`Condition or disease 
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`Age Related Macular Degeneration
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`Intervention/treatment 
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`Drug: ranibizumab
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`Drug: bevacizumab
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`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 Western countries. More than 1.6 million people in the US currently have one or both eyes
`affected by the advanced stage of AMD.
`
`Lucentis® is the most effective treatment for neovascular AMD studied 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 the potential to reduce the treatment
`burden to patients as well as to reduce the overall cost of therapy.
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`Only a single eye in each patient was analyzed.
`
`At the 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.
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`Study Design
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`Interventional (Clinical Trial)
`Study Type  :
`Actual Enrollment  : 1208 participants
`Allocation: Randomized
`Intervention Model: Parallel Assignment
`Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose: Treatment
`Official Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
`Actual Study Start Date  : February 2008
`Actual Primary Completion Date  : December 2010
`Actual Study Completion Date  : April 2015
`
`Resource links provided by the National Library of Medicine
`
`MedlinePlus Genetics related topics: Age-related macular degeneration
`
`MedlinePlus related topics: Macular Degeneration
`
`Drug Information available for: Bevacizumab Ranibizumab
`
`U.S. FDA Resources
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`Arms and Interventions
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`Go to
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`Go to
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`https://clinicaltrials.gov/ct2/show/NCT00593450
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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
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`Arm 
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`Intervention/treatment 
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`Active Comparator: 1
`Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks
`or to variable dosing.
`
`Drug: ranibizumab
`• 0.5 mg (0.05 mL)intravitreal injection
`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 mL)intravitreal 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 mL)intravitreal injection
`Other Name: Lucentis
`
`Experimental: 4
`Avastin® on a variable dosing schedule for 2 years; i.e., 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
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`Go to
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`Primary Outcome Measures  :
`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.
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`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.
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`Secondary Outcome 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 VA score is ranged from 0 to 97, with the higher score the better visual acuity.
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`4. Number of Treatments [ Time Frame: 1 Year ]
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`Cumulative over the 1 year of trial
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`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
`
`Go to
`
`Information from the National Library of Medicine
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or
`your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
`
`Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
`Sexes Eligible for Study: All
`Accepts Healthy Volunteers: No
`
`Criteria
`Inclusion Criteria:
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`Active, subfoveal choroidal neovascularization (CNV)
`Fibrosis < 50% of total lesion area
`Visual acuity (VA) 20/25-20/320
`Age ≥ 50 yrs
`At least 1 drusen (>63μ) in either eye or late AMD in fellow eye
`
`Exclusion Criteria:
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`Previous treatment for CNV in study eye
`Other progressive retinal disease likely to compromise VA
`Contraindications to injections with Lucentis or Avastin
`
`Contacts and Locations
`
`https://clinicaltrials.gov/ct2/show/NCT00593450
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`Go to
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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
`
`Information from the National Library of Medicine
`
`To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593450
`
`Locations
`
` Show 59 study locations
`
`Sponsors and Collaborators
`University of Pennsylvania
`
`National Eye Institute (NEI)
`
`Investigators
`Study Chair:
`
`Study Chair:
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`Study Director:
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`Study Director:
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`Daniel F Martin, MD
`
`The Cleveland Clinic
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`Stuart L Fine, MD
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`Study Vice-Chair, University of Pennsylvania
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`Maureen G Maguire, PhD Director of Coordinating Center, University of Pennsylvania
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`Glenn Jaffe,, MD
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`Director of OCT Reading Center, Duke University
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`Principal Investigator:
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`Juan E Grunwald, MD
`
`Principal Investigator of Photography Reading Center, Universisty of Pennsylvania
`
`More Information
`
`Additional Information:
`
`Click here for more information about this study: Comparison of AMD Treatments Trials (CATT)
`
`NEI Clinical Studies Database
`
`Publications of Results:
`
`Go to
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`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):1897-908. doi:
`10.1056/NEJMoa1102673. Epub 2011 Apr 28.
`
`Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group; Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, Grunwald JE, Toth C, Redford M, Ferris FL 3rd. Ranibizumab and bevacizumab for treatment
`of neovascular age-related macular degeneration: two-year results. Ophthalmology. 2012 Jul;119(7):1388-98. doi: 10.1016/j.ophtha.2012.03.053. Epub 2012 May 1.
`
`Grunwald JE, Daniel E, Ying GS, Pistilli M, Maguire MG, Alexander J, Whittock-Martin R, Parker CR, Sepielli K, Blodi BA, Martin DF; CATT Research Group. Photographic assessment of baseline fundus morphologic features in the
`Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2012 Aug;119(8):1634-41. doi: 10.1016/j.ophtha.2012.02.013. Epub 2012 Apr 17.
`
`Martin DF, Maguire MG, Fine SL. Bevacizumab: not as good with more adverse reactions? Response. Clin Exp Ophthalmol. 2011 Sep-Oct;39(7):718-20. doi: 10.1111/j.1442-9071.2011.02703.x. No abstract available.
`
`Cheung CM, Wong TY. Ranibizumab and bevacizumab for AMD. N Engl J Med. 2011 Dec 8;365(23):2237; author reply 2237. doi: 10.1056/NEJMc1107895. No abstract available.
`
`DeCroos FC, Toth CA, Stinnett SS, Heydary CS, Burns R, Jaffe GJ; CATT Research Group. Optical coherence tomography grading reproducibility during the Comparison of Age-related Macular Degeneration Treatments Trials.
`Ophthalmology. 2012 Dec;119(12):2549-57. doi: 10.1016/j.ophtha.2012.06.040. Epub 2012 Aug 28.
`
`Ying GS, Huang J, Maguire MG, Jaffe GJ, Grunwald JE, Toth C, Daniel E, Klein M, Pieramici D, Wells J, Martin DF; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Baseline predictors for one-year
`visual outcomes with ranibizumab or bevacizumab for neovascular age-related macular degeneration. Ophthalmology. 2013 Jan;120(1):122-9. doi: 10.1016/j.ophtha.2012.07.042. Epub 2012 Oct 6.
`
`Hagstrom SA, Ying GS, Pauer GJT, Sturgill-Short 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
`macular degeneration in the Comparison of AMD Treatments Trials (CATT). Ophthalmology. 2013 Mar;120(3):593-599. doi: 10.1016/j.ophtha.2012.11.037. Epub 2013 Jan 18.
`
`Jaffe GJ, Martin DF, Toth CA, Daniel E, Maguire MG, Ying GS, Grunwald JE, Huang J; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Macular morphology and visual acuity in the comparison of age-
`related macular degeneration treatments trials. Ophthalmology. 2013 Sep;120(9):1860-70. doi: 10.1016/j.ophtha.2013.01.073. Epub 2013 May 1.
`
`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 of Age-Related Macular Degeneration Treatments Trials (CATT Research
`Group). Incidence of choroidal neovascularization in the fellow eye in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2013 Oct;120(10):2035-41. doi: 10.1016/j.ophtha.2013.03.017. Epub 2013 May 22.
`
`Daniel E, Toth CA, Grunwald JE, Jaffe GJ, Martin DF, Fine SL, Huang J, Ying GS, Hagstrom SA, Winter K, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Risk of scar in the comparison of
`age-related macular degeneration treatments trials. Ophthalmology. 2014 Mar;121(3):656-66. doi: 10.1016/j.ophtha.2013.10.019. Epub 2013 Dec 4.
`
`Grunwald JE, Daniel E, Huang J, Ying GS, Maguire MG, Toth CA, Jaffe GJ, Fine SL, Blodi B, Klein ML, Martin AA, Hagstrom SA, Martin DF; CATT Research Group. Risk of geographic atrophy in the comparison of age-related macular
`degeneration treatments trials. Ophthalmology. 2014 Jan;121(1):150-161. doi: 10.1016/j.ophtha.2013.08.015. Epub 2013 Sep 29.
`
`Hagstrom SA, Ying GS, Pauer GJ, Sturgill-Short GM, Huang J, Maguire MG, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group. VEGFA and VEGFR2 gene polymorphisms and
`response to anti-vascular endothelial growth factor therapy: comparison of age-related macular degeneration treatments trials (CATT). JAMA Ophthalmol. 2014 May;132(5):521-7. doi: 10.1001/jamaophthalmol.2014.109.
`
`Kim BJ, Ying GS, Huang J, Levy NE, Maguire MG; CATT Research Group. Sporadic visual acuity loss in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J Ophthalmol. 2014 Jul;158(1):128-135.e10. doi:
`10.1016/j.ajo.2014.04.004. Epub 2014 Apr 13.
`
`Folgar FA, Jaffe GJ, Ying GS, Maguire MG, Toth CA; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Comparison of optical coherence tomography assessments in the comparison of age-related
`macular degeneration treatments trials. Ophthalmology. 2014 Oct;121(10):1956-65. doi: 10.1016/j.ophtha.2014.04.020. Epub 2014 May 15.
`
`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):915-21. doi: 10.1001/jamaophthalmol.2014.1019.
`
`Gewaily DY, Grunwald JE, Pistilli M, Ying GS, Maguire MG, Daniel E, Ostroff CP, Fine SL; CATT Research Group. Delayed patchy choroidal filling in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J
`Ophthalmol. 2014 Sep;158(3):525-31.e2. doi: 10.1016/j.ajo.2014.06.004. Epub 2014 Jun 17.
`
`Lee JY, Folgar FA, Maguire MG, Ying GS, Toth CA, Martin DF, Jaffe GJ; CATT Research Group. Outer retinal tubulation in the comparison of age-related macular degeneration treatments trials (CATT). Ophthalmology. 2014
`Dec;121(12):2423-31. doi: 10.1016/j.ophtha.2014.06.013. Epub 2014 Jul 23.
`
`Moja L, Lucenteforte E, Kwag KH, Bertele V, Campomori A, Chakravarthy U, D'Amico R, Dickersin K, Kodjikian L, Lindsley K, Loke Y, Maguire M, Martin DF, Mugelli A, Muhlbauer B, Puntmann I, Reeves B, Rogers C, Schmucker C,
`Subramanian ML, Virgili G. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014 Sep 15;9(9):CD011230. doi: 10.1002/14651858.CD011230.pub2.
`
`Altaweel MM, Daniel E, Martin DF, Mittra RA, Grunwald JE, Lai MM, Melamud A, Morse LS, Huang J, Ferris FL 3rd, Fine SL, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group;
`Comparison of Age-related Macular Degeneration Treatments Trials CATT Research Group. Outcomes of eyes with lesions composed of >50% blood in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT).
`Ophthalmology. 2015 Feb;122(2):391-398.e5. doi: 10.1016/j.ophtha.2014.08.020. Epub 2014 Oct 11.
`
`Grunwald JE, Pistilli M, Ying GS, Maguire MG, Daniel E, Martin DF; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Growth of geographic atrophy in the comparison of age-related macular degeneration
`treatments trials. Ophthalmology. 2015 Apr;122(4):809-16. doi: 10.1016/j.ophtha.2014.11.007. Epub 2014 Dec 24.
`
`Meredith TA, McCannel CA, Barr C, Doft BH, Peskin E, Maguire MG, Martin DF, Prenner JL; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Postinjection endophthalmitis in the comparison of age-
`related macular degeneration treatments trials (CATT). Ophthalmology. 2015 Apr;122(4):817-21. doi: 10.1016/j.ophtha.2014.10.027. Epub 2015 Jan 15.
`
`https://clinicaltrials.gov/ct2/show/NCT00593450
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`Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial - Full Text View - ClinicalTrials.gov
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`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.
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`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.
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`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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`Celltrion Exhibit 1022
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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
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`5/5
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`Celltrion Exhibit 1022
`Page 5
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