drugset / Trial / NCT00593450
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
RandomizedParallel-groupTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2008-02
- Primary completion
- 2010-12
- Completion
- 2015-04
Publications
- Background 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.
- 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):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- 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. 2023 Jul;107(7):1000-1006. doi: 10.1136/bjophthalmol-2021-320665. Epub 2022 Apr 15.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 1.25 mg | Intravitreal |
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |