Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

NCT ID: NCT00593450


Title
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Purpose
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.
Details
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. 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.
Conditions
Age Related Macular Degeneration
Keywords
bevacizumab, ranibizumab, choroidal neovascularization
Source
University of Pennsylvania
Sponsors
University of Pennsylvania, National Eye Institute (NEI)
Status
Active, not recruiting
Acronym
Last Updated
09 Oct 2016
URL
Official Link
Citations/Publications
Martin DF, Maguire MG, Fine SL. Ranibizumab and bevacizumab for AMD. Authors reply. N Engl J Med 2011; 365:2237

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.

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.

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.

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.

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.

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.

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.

Hagstrom SA, Ying GS, Pauer GJ, 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):593-9. doi: 10.1016/j.ophtha.2012.11.037.

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.

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.

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.

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):150-61. doi: 10.1016/j.ophtha.2013.08.015.

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.

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.

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.

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.

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.

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, Mühlbauer B, Püntmann 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):CD011230. doi: 10.1002/14651858.CD011230.pub2. Review.

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.

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.

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.

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. 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.

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.

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.

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):352-60. doi: 10.1016/j.ophtha.2015.09.046.

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.

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.

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.

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.

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.

Locations
United States