A crossover design for comparative efficacy: A 36-week randomized trial of bevacizumab and ranibizumab for diabetic macular edema

Ophthalmology

Volumn 123, Issue 4, 2016, Pages 841-849

  Wiley, Henry E ^a   Thompson, Darby J S ^b   Bailey, Clare ^c   Chew, Emily Y ^a   Cukras, Catherine A ^a   Jaffe, Glenn J ^d   Lee, Richard W J ^c,e,f   Loken, Erin K ^b   Meyerle, Catherine B ^g   Wong, Wai ^a   Ferris, Frederick L ^a  

^a NATIONAL EYE INSTITUTE   (United States)

^b EMMES CORPORATION   (United States)

^c UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST   (United Kingdom)

^d DUKE UNIVERSITY EYE CENTER   (United States)

^e UNIVERSITY OF BRISTOL   (United Kingdom)

^f UNIVERSITY COLLEGE LONDON   (United Kingdom)

^g JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; RANIBIZUMAB; ANGIOGENESIS INHIBITOR; VASCULOTROPIN A; VEGFA PROTEIN, HUMAN;

ADULT; AGED; BRAIN HEMORRHAGE; CENTRAL RETINAL THICKNESS; CENTRAL SUBFIELD MEAN THICKNESS; COMPARATIVE EFFECTIVENESS; CONFERENCE PAPER; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIABETIC MACULAR EDEMA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ENDOPHTHALMITIS; FEMALE; HUMAN; INTRAOCULAR PRESSURE; MAJOR CLINICAL STUDY; MALE; OPTICAL COHERENCE TOMOGRAPHY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETINA DETACHMENT; TRAUMATIC CATARACT; VISUAL ACUITY; VISUAL IMPAIRMENT; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; COMPARATIVE STUDY; COMPLICATION; DIABETIC RETINOPATHY; DRUG EFFECTS; INSULIN DEPENDENT DIABETES MELLITUS; INTRAVITREAL DRUG ADMINISTRATION; MACULAR EDEMA; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATHOLOGY; PATHOPHYSIOLOGY; RETINA; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; BEVACIZUMAB; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DIABETIC RETINOPATHY; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTRAVITREAL INJECTIONS; MACULAR EDEMA; MALE; MIDDLE AGED; RANIBIZUMAB; RESEARCH DESIGN; RETINA; TOMOGRAPHY, OPTICAL COHERENCE; VASCULAR ENDOTHELIAL GROWTH FACTOR A; VISUAL ACUITY;

EID: 84957923016     PISSN: 01616420     EISSN: 15494713     Source Type: Journal    
DOI: 10.1016/j.ophtha.2015.11.021     Document Type: Conference Paper

References (40)

1. Diabetic Retinopathy Clinical Research Network Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema N Engl J Med 372 2015 1193 1203
2. Diabetic Retinopathy Clinical Research Network Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema Ophthalmology 117 2010 1064 1077.e35
3. P. Mitchell, F. Bandello, U. Schmidt-Erfurth, and et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema Ophthalmology 118 2011 615 625
4. Q.D. Nguyen, D.M. Brown, D.M. Marcus, and et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE Ophthalmology 119 2012 789 801
5. J.F. Korobelnik, D.V. Do, U. Schmidt-Erfurth, and et al. Intravitreal aflibercept for diabetic macular edema Ophthalmology 121 2014 2247 2254
6. J.F. Arevalo, J. Fromow-Guerra, H. Quiroz-Mercado, and et al. Primary intravitreal bevacizumab (Avastin) for diabetic macular edema: results from the Pan-American Collaborative Retina Study Group at 6-month follow-up Ophthalmology 114 2007 743 750
7. I.U. Scott, A.R. Edwards, R.W. Beck, and et al. A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema Ophthalmology 114 2007 1860 1867
8. D. Kook, A. Wolf, T. Kreutzer, and et al. Long-term effect of intravitreal bevacizumab (Avastin) in patients with chronic diffuse diabetic macular edema Retina 28 2008 1053 1060
9. M. Soheilian, A. Ramezani, A. Obudi, and et al. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema Ophthalmology 116 2009 1142 1150
10. M. Michaelides, A. Kaines, R.D. Hamilton, and et al. A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2 Ophthalmology 117 2010 1078 1086.e2
11. M.C. Gillies, L.L. Lim, A. Campain, and et al. A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX Study Ophthalmology 121 2014 2473 2481
12. M.L. Subramanian, G. Abedi, S. Ness, and et al. Bevacizumab versus ranibizumab for age-related macular degeneration: 1-year outcomes of a prospective, double-masked, randomised clinical trial Eye 24 2010 1708 1715
13. D.F. Martin, M.G. Maguire, G.S. Ying, and et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration N Engl J Med 364 2011 1897 1908
14. P. Biswas, S. Sengupta, R. Choudhary, and et al. Comparative role of intravitreal ranibizumab versus bevacizumab in choroidal neovascular membrane in age-related macular degeneration Indian J Ophthalmol 59 2011 191 196
15. U. Chakravarthy, S.P. Harding, C.A. Rogers, and et al. Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial Ophthalmology 119 2012 1399 1411
16. L. Kodjikian, E.H. Souied, G. Mimoun, and et al. Ranibizumab versus bevacizumab for neovascular age-related macular degeneration: Results from the GEFAL noninferiority randomized trial Ophthalmology 120 2013 2300 2309
17. I. Krebs, L. Schmetterer, A. Boltz, and et al. A randomized, double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration Br J Ophthalmol 97 2013 266 271
18. J.R. Woods, J.G. Williams, and M. Tavel The two-period crossover design in medical research Ann Intern Med 110 1989 560 566
19. A.F. Ebbutt Three-period crossover designs for two treatments Biometrics 40 1984 219 224
20. K.C. Carriere Crossover designs for clinical trials Stat Med 13 1994 1063 1069
21. B. Jones, and M.G. Kenward Design and Analysis of Cross-Over Trials Second ed. 2003 Chapman and Hall/CRC Boca Raton, FL
22. S.B. Bressler, A.R. Edwards, K.V. Chalam, and et al. Reproducibility of spectral-domain optical coherence tomography retinal thickness measurements and conversion to equivalent time-domain metrics in diabetic macular edema JAMA Ophthalmol 132 2014 1113 1122
23. A.B. Thach, L. Yau, C. Hoang, and et al. Time to clinically significant visual acuity gains after ranibizumab treatment for retinal vein occlusion: BRAVO and CRUISE trials Ophthalmology 121 2014 1059 1066
24. S. Wellek, and M. Blettner On the proper use of the crossover design in clinical trials: part 18 of a series on evaluation of scientific publications Dtsch Ärztebl Int 109 2012 276 281
25. K.C. Carriere, and R. Huang Crossover designs for two-treatment clinical trials J Stat Plan Inference 87 2000 125 134
26. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs, E14. 2005. Available at: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E14/E14-Guideline.pdf. Accessed July 17, 2015.
27. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Guidance for Industry: Statistical Approaches to Establishing Bioequivalence 2001 Available at: http://www.fda.gov/downloads/Drugs/Guidances/ucm070244.pdf Accessed July 17, 2015
28. T.U. Krohne, N. Eter, F.G. Holz, and C.H. Meyer Intraocular pharmacokinetics of bevacizumab after a single intravitreal injection in humans Am J Ophthalmol 146 2008 508 512
29. T.U. Krohne, Z. Liu, F.G. Holz, and C.H. Meyer Intraocular pharmacokinetics of ranibizumab following a single intravitreal injection in humans Am J Ophthalmol 154 2012 682 686.e2
30. I. Gilron, J.M. Bailey, D. Tu, and et al. Nortriptyline and gabapentin, alone and in combination for neuropathic pain: a double-blind, randomised controlled crossover trial Lancet 374 2009 1252 1261
31. B.L. Zuraw, P.J. Busse, M. White, and et al. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema N Engl J Med 363 2010 513 522
32. C. Leissinger, A. Gringeri, B. Antmen, and et al. Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors N Engl J Med 365 2011 1684 1692
33. C. Vanpouille, A. Lisco, J.C. Grivel, and et al. Valacyclovir decreases plasma HIV-1 RNA in HSV-2 seronegative individuals: a randomized placebo-controlled crossover trial Clin Infect Dis 60 2015 1708 1714
34. B.S. Berthon, P.G. Gibson, P. McElduff, and et al. Effects of short-term oral corticosteroid intake on dietary intake, body weight and body composition in adults with asthma - a randomized controlled trial Clin Exp Allergy 45 2015 908 919
35. H.E. Lebovitz, B. Ludvik, J. Kozakowski, and et al. Gastric electrical stimulation treatment of type 2 diabetes: effects of implantation versus meal-mediated stimulation. A randomized blinded cross-over trial Physiol Rep 3 2015 e12456
36. H. Thabit, M. Tauschmann, J.M. Allen, and et al. Home use of an artificial beta cell in type 1 diabetes N Engl J Med 373 2015 2129 2140
37. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Guideline for the Format and Content of the Clinical and Statistical Sections of an Application 1988 Available at: http://www.fda.gov/downloads/Drugs/./Guidances/UCM071665.pdf Accessed October 22, 2015
38. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva, Switzerland. Statistical Principles for Clinical Trials, E9. 1998. Available at: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E9/Step4/E9-Guideline.pdf. Accessed October 22, 2015.
39. P. Iacono, M.B. Parodi, A. Papayannis, and et al. Intravitreal ranibizumab versus bevacizumab for treatment of myopic choroidal neovascularization Retina 32 2012 1539 1546
40. S. Wolf, V.J. Balciuniene, G. Laganovska, and et al. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia Ophthalmology 121 2014 682 692