Effect of bevacizumab vs aflibercept on visual acuity among patients with macular edema due to central retinal vein occlusion the SCORE2 randomized clinical trial

JAMA - Journal of the American Medical Association

Volumn 317, Issue 20, 2017, Pages 2072-2087

  Scott, Ingrid U ^a   Van Veldhuisen, Paul C ^b   Ip, Michael S ^c   Blodi, Barbara A ^d   Oden, Neal L ^b   Awh, Carl C ^e   Kunimoto, Derek Y ^f   Marcus, Dennis M ^g   Wroblewski, John J ^h   King, Jacqueline ^b  

^a PENN STATE COLLEGE OF MEDICINE   (United States)

^b EMMES CORPORATION   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF WISCONSIN MADISON   (United States)

^e Tennessee Retina   (United States)

^f RETINAL CONSULTANTS OF ARIZONA   (United States)

^g Southeast Retina Center   (United States)

^h Cumberland Valley Retina Consultants   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AFLIBERCEPT; BEVACIZUMAB; ANGIOGENESIS INHIBITOR; HYBRID PROTEIN; VASCULOTROPIN A; VASCULOTROPIN RECEPTOR;

ACUTE HEART INFARCTION; ADULT; AGED; ARTICLE; CENTRAL RETINA VEIN OCCLUSION; CENTRAL RETINAL ARTERY NONPERFUSION; CEREBROVASCULAR ACCIDENT; CLOSED ANGLE GLAUCOMA; CONTROLLED STUDY; ENDOPHTHALMITIS; EYE DISEASE; EYE SURGERY; FEMALE; HEART INFARCTION; HEMIRETINAL VEIN OCCLUSION; HUMAN; INTRAOCULAR PRESSURE; MACULAR EDEMA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NEOVASCULAR GLAUCOMA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETINA ARTERY OCCLUSION; RETINA DETACHMENT; SIDE EFFECT; SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY; UNITED STATES; VERY ELDERLY; VISUAL ACUITY; VISUAL ACUITY LETTER SCORE; VITREOUS HEMORRHAGE; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; COMPLICATION; DRUG EFFECTS; EYE FUNDUS; INTRAVITREAL DRUG ADMINISTRATION; OFF LABEL DRUG USE; RETINA VEIN OCCLUSION;

AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; BEVACIZUMAB; FEMALE; FUNDUS OCULI; HUMANS; INTRAVITREAL INJECTIONS; MACULAR EDEMA; MALE; MIDDLE AGED; OFF-LABEL USE; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; RECOMBINANT FUSION PROTEINS; RETINAL VEIN OCCLUSION; VASCULAR ENDOTHELIAL GROWTH FACTOR A; VISUAL ACUITY;

EID: 85019585340     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.4568     Document Type: Article

References (30)

1. Ponto KA, Elbaz H, Peto T, et al. Prevalence and risk factors of retinal vein occlusion: The Gutenberg Health Study. J Thromb Haemost. 2015;13(7):1254- 1263.
2. Klein R, Klein BE, Moss SE, Meuer SM. The epidemiology of retinal vein occlusion: The Beaver Dam Eye Study. Trans Am Ophthalmol Soc. 2000;98:133-141.
3. Mitchell P, SmithW, Chang A. Prevalence and associations of retinal vein occlusion in Australia: The Blue Mountains Eye Study. Arch Ophthalmol. 1996;114(10):1243-1247.
4. Rogers S, McIntosh RL, Cheung N, et al; International Eye Disease Consortium. The prevalence of retinal vein occlusion: Pooled data from population studies from the United States, Europe, Asia, and Australia. Ophthalmology. 2010;117(2):313-319, e1.
5. Central Vein Occlusion Study Group. Natural history and clinical management of central retinal vein occlusion. Arch Ophthalmol. 1997;115(4):486- 491.
6. Boyer D, Heier J, Brown DM, et al. Vascular endothelial growth factor Trap-Eye for macular edema secondary to central retinal vein occlusion: Six-month results of the phase 3 COPERNICUS study. Ophthalmology. 2012;119(5):1024-1032.
7. Holz FG, Roider J, Ogura Y, et al. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEOstudy. Br J Ophthalmol. 2013;97(3):278-284.
8. Prager F, Michels S, Kriechbaum K, et al. Intravitreal bevacizumab (Avastin) for macular oedema secondary to retinal vein occlusion: 12-month results of a prospective clinical trial. Br J Ophthalmol. 2009;93(4):452-456.
9. Wu L, Arevalo JF, Berrocal MH, et al. Comparison of two doses of intravitreal bevacizumab as primary treatment for macular edema secondary to central retinal vein occlusion: Results of the pan American collaborative retina study group at 24 months. Retina. 2010;30(7):1002-1011.
10. Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ; CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011;364(20):1897-1908.
11. Wells JA, Glassman AR, Ayala AR, et al; Diabetic Retinopathy Clinical Research Network. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372(13):1193-1203.
12. Office of Inspector General, Department of Health and Human Services. Medicare Payments for Drugs Used to TreatWet Age-Related Macular Degeneration.Washington, DC: Dept of Health & Human Services; 2012. Publication OEI-03-10- 00360.
13. American Academy of Pediatrics. Red Book Online [database online]. Elk Grove Village, IL: American Academy of Pediatrics; 2016.
14. World Medical Association. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191-2194.
15. Scott IU, Vanveldhuisen PC, Oden NL, et al; SCORE Study Investigator Group. Baseline characteristics and response to treatment of participants with hemiretinal compared with branch retinal or central retinal vein occlusion in the standard care vs corticosteroid for retinal vein occlusion (SCORE) study: SCORE study report 14. Arch Ophthalmol. 2012;130(12):1517-1524.
16. Brown DM, Campochiaro PA, Singh RP, et al; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: Six-month primary end point results of a phase III study. Ophthalmology. 2010;117(6):1124-1133, e1.
17. StewartMW. Aflibercept (VEGF Trap-eye): The newest anti-VEGF drug. Br J Ophthalmol. 2012;96 (9):1157-1158.
18. IpMS, Oden NL, Scott IU, et al; SCORE Study Investigator Group. SCORE Study report 3: Study design and baseline characteristics. Ophthalmology. 2009;116(9):1770-1777, e1.
19. Beck RW, Moke PS, Turpin AH, et al. A computerized method of visual acuity testing: Adaptation of the early treatment of diabetic retinopathy study testing protocol. Am J Ophthalmol. 2003;135(2):194-205.
20. Gross JG, Glassman AR, Jampol LM, et al; Writing Committee for the Diabetic Retinopathy Clinical Research Network. Panretinal photocoagulation vs intravitreous ranibizumab for proliferative diabetic retinopathy: A randomized clinical trial. JAMA. 2015;314(20):2137-2146.
21. Beck RW, Maguire MG, Bressler NM, Glassman AR, Lindblad AS, Ferris FL. Visual acuity as an outcome measure in clinical trials of retinal diseases. Ophthalmology. 2007;114(10):1804-1809.
22. Antiplatelet Trialists' Collaboration. Collaborative overview of randomised trials of antiplatelet therapy-I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ. 1994;308(6921):81-106.
23. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika. 1983;70 (3):659-663. doi:10.1093/biomet/70.3.659
24. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika. 1988; 75(4):800-802. doi:10.1093/biomet/75.4.800
25. Wells JA, Glassman AR, Ayala AR, et al; Diabetic Retinopathy Clinical Research Network. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: Two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology. 2016;123(6):1351-1359.
26. Kitchens JW, Do DV, Boyer DS, et al. Comprehensive review of ocular and systemic safety events with intravitreal aflibercept injection in randomized controlled trials. Ophthalmology. 2016;123(7):1511-1520.
27. Heier JS, Clark WL, Boyer DS, et al. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: Two-year results from the COPERNICUS study. Ophthalmology. 2014;121(7):1414-1420, e1.
28. Campochiaro PA, Brown DM, Awh CC, et al. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: Twelve-month outcomes of a phase III study. Ophthalmology. 2011;118(10):2041-2049.
29. Brown DM, Campochiaro PA, Bhisitkul RB, et al. Sustained benefits from ranibizumab for macular edema following branch retinal vein occlusion: 12-month outcomes of a phase III study. Ophthalmology. 2011;118(8):1594-1602.
30. VanderBeek BL, Bonaffini SG, Ma L. Association of compounded bevacizumab with postinjection endophthalmitis. JAMA Ophthalmol. 2015;133(10):1159-1164.