Anti-vascular endothelial growth factor for diabetic macular oedema

Cochrane Database of Systematic Reviews

Volumn 2014, Issue 10, 2014, Pages

  Virgili, Gianni ^a   Parravano, Mariacristina ^b   Menchini, Francesca ^c   Evans, Jennifer R ^d  

^a UNIVERSITY OF FLORENCE   (Italy)

^b IRCCS FONDAZIONE BIETTI   (Italy)

^c UNIVERSITY HOSPITAL OF UDINE   (Italy)

^d LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AFLIBERCEPT; BEVACIZUMAB; PEGAPTANIB; PLACEBO; RANIBIZUMAB; VASCULOTROPIN ANTIBODY; ANGIOGENESIS INHIBITOR; APTAMER; HYBRID PROTEIN; MONOCLONAL ANTIBODY; TRIAMCINOLONE; VASCULOTROPIN A; VASCULOTROPIN RECEPTOR;

ANTIANGIOGENIC THERAPY; ARTERY THROMBOSIS; COMPARATIVE EFFECTIVENESS; COST EFFECTIVENESS ANALYSIS; DIABETIC MACULAR EDEMA; DRUG APPROVAL; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; ENDOPHTHALMITIS; HUMAN; LASER COAGULATION; LOW DRUG DOSE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; TREATMENT DURATION; TREATMENT OUTCOME; VISUAL ACUITY; VISUAL IMPAIRMENT; ANTAGONISTS AND INHIBITORS; COMPLICATION; DIABETIC RETINOPATHY; MACULAR EDEMA; META ANALYSIS; PROCEDURES;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; APTAMERS, NUCLEOTIDE; BEVACIZUMAB; DIABETIC RETINOPATHY; HUMANS; LASER COAGULATION; MACULAR EDEMA; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RANIBIZUMAB; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; RECOMBINANT FUSION PROTEINS; TRIAMCINOLONE; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84925437893     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD007419.pub4     Document Type: Review

References (161)

1. Ahmadieh H, Ramezani A, Shoeibi N, Bijanzadeh B, Tabatabaei A, Azarmina M, et al.Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial. Graefe's Archive for Clinical and Experimental Ophthalmology 2008;246(4):483-9.
2. Azad R, Sain S, Sharma YR, Mahajan D. Comparison of intravitreal bevacizumab, intravitreal triamcinolone acetonide, and macular grid augmentation in refractory diffuse diabetic macular edema: A prospective, randomized study. Oman Journal of Ophthalmology 2012; Vol. 5, issue 3:166-70.
3. Michaelides M, Kaines A, Hamilton RD, Fraser-Bell S, Rajendram R, Quhill F, 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 2010;117(6):1078-86.
4. Rajendram R, Fraser-Bell S, Kaines A, Michaelides M, Hamilton RD, Esposti SD, et al.A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: report 3. Archives of Ophthalmology 2012;130(8):972-9.
5. Sivaprasad S, Crosby-Nwaobi R, Esposti S, Peto T, Rajendram R, Michaelides M, et al.Structural and functional measures of efficacy in response to bevacizumab monotherapy in diabetic macular oedema: exploratory analyses of the BOLT Study (Report 4). PloS ONE 2013;8(8):e72755.
6. Do DV, Nguyen QD, Boyer D, Schmidt-Erfurth U, Brown DM, Vitti R, et al.One-year outcomes of the DA VINCI Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology 2012;119(8):1658-65.
7. Do DV, Schmidt-Erfurth U, Gonzalez VH, Gordon CM, Tolentino M, Berliner AJ, et al.The DAVINCI Study: phase 2 primary results of VEGF Trap-Eye in patients with diabetic macular edema. Ophthalmology 2011;118(9):1819-26.
8. Anonymous . Erratum: Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: Randomized clinical trial (JAMA Ophthalmology (2013) 131:10 (1339-1347) DOI: 10.1001/jamaophthalmol.2013.4592). JAMA Ophthalmology 2013;131(12):1652.
9. Bressler SB, Qin H, Beck RW, Chalam KV, Kim JE, Melia M, et al.Factors associated with changes in visual acuity and central subfield thickness at 1 year after treatment for diabetic macular edema with ranibizumab. Archives of Ophthalmology 2012;130(9):1153-61.
10. Bressler SB, Qin H, Melia M, Bressler NM, Beck RW, Chan CK, et al.Exploratory analysis of the effect of intravitreal ranibizumab or triamcinolone on worsening of diabetic retinopathy in a randomized clinical trial. JAMA Ophthalmology 2013;131(8):1033-40.
11. Dewan V, Lambert D, Edler J, Kymes S, Apte RS. Cost-effectiveness analysis of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2012;119(8):1679-84.
12. Diabetic Retinopathy Clinical Research Network, Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, et al.Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2010;117(6):1064-77.
13. Elman MJ, Bressler NM, Qin H, Beck RW, Ferris FL 3rd, Friedman SM, et al.Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2011;118(4):609-14.
14. Elman MJ, Qin H, Aiello LP, Beck RW, Bressler NM, Ferris FL, et al.Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results. Ophthalmology 2012;119(11):2312-8.
15. Ekinci M, Ceylan E, Cakici O, Tanyildiz B, Olcaysu O, Cagatay HH. Treatment of macular edema in diabetic retinopathy: Comparison of the efficacy of intravitreal bevacizumab and ranibizumab injections. Expert Review of Ophthalmology 2014;9(2):139-43.
16. Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, et al.Intravitreal aflibercept for diabetic macular edema. Ophthalmology 2014 Jul 8 [Epub ahead of print].
17. Comyn O, Sivaprasad S, Peto T, Neveu MM, Holder GE, Xing W, et al.A randomized trial to assess functional and structural effects of ranibizumab versus laser in diabetic macular edema (the LUCIDATE study). American Journal of Ophthalmology 2014; Vol. 157, issue 5:960-70.
18. Cunningham ET Jr, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ, et al.A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 2005;112(10):1747-57.
19. Loftus JV, Sultan MB, Pleil AM, Macugen 1013 Study Group. Changes in vision and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Investigative Ophthalmology and Visual Science 2011;52(10):7498-505.
20. Sultan MB, Zhou D, Loftus J, Dombi T, Ice KS, Macugen 1013 Study Group. A phase 2/3, multicenter, randomized, double-masked, 2-year trial of pegaptanib sodium for the treatment of diabetic macular edema. Ophthalmology 2011;118(6):1107-18.
21. CRFB002DD13 . A 12-month, two-armed, randomized, double-masked, multicenter, phase IIIb study assessing the efficacy and safety of laser photocoagulation as adjunctive to ranibizumab intravitreal injections vs. laser photocoagulation monotherapy in patients with visual impairment due to diabetic macular edema followed by a 12 month follow up period. Novartis clinical trial results database www.novctrd.com/ctrdWebApp/clinicaltrialrepository/public/login.jsp (accessed 2 June 2014).
22. NCT01131585 . A 12-month, two-armed, randomized, double-masked, multicenter, phase IIIb study assessing the efficacy and safety of laser photocoagulation as adjunctive to ranibizumab intravitreal injections vs. laser photocoagulation monotherapy in patients with visual impairment due to diabetic macular edema followed by a 12 month follow up period. clinicaltrials.gov/show/NCT01131585 (accessed 15 October 2012).
23. Nepomuceno AB, Takaki E, Paes de Almeida FP, Peroni R, Cardillo JA, Siqueira RC, et al.A prospective randomized trial of intravitreal bevacizumab versus ranibizumab for the management of diabetic macular edema. American Journal of Ophthalmology 2013;156(3):502-10.
24. Do DV, Nguyen QD, Khwaja AA, Channa R, Sepah YJ, Sophie R, et al.Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment. JAMA Ophthalmology 2013;131(2):139-45.
25. Nguyen QD, Shah SM, Heier JS, Do DV, Lim J, Boyer D, et al.Primary end point (six months) results of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology 2009;116(11):2175-81.
26. Nguyen QD, Shah SM, Khwaja AA, Channa R, Hatef E, Do DV, et al.Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology 2010;117(11):2146-51.
27. CRFB002D2201 . A randomized, double-masked, multicenter, phase II study assessing the safety and efficacy of two concentrations of ranibizumab (intravitreal injections) compared with non-treatment control for the treatment of diabetic macular edema with center involvement. Novartis clinical trial results database www.novctrd.com/ctrdWebApp/clinicaltrialrepository/public/login.jsp (accessed 2 June 2014).
28. Massin P, Bandello F, Garweg JG, Hansen LL, Harding SP, Larsen M, et al.Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care 2010;33(11):2399-405.
29. Berger A, Sheidow T, Li R, Rehel B, De Takacsy F, Courseau AS. A Canadian 12-month, phase IIIb study of ranibizumab combination or monotherapy in visual impairment due to diabetic macular edema: Preliminary analysis ("RESPOND"). 16th Annual Canadian Diabetes Association/Canadian Society of Endocrinology and Metabolism Professional Conference and Annual Meetings; 2013 Oct 17-19; Montreal. 2013.
30. CRFB002DCA05 . A Canadian 12-month, prospective, randomized, open-label, multicenter, phase IIIb study assessing the efficacy, safety and cost of ranibizumab as combination and monotherapy in patients with visual impairment due to diabetic macular edema. Novartis clinical trial results database www.novctrd.com/ctrdWebApp/clinicaltrialrepository/public/login.jsp (accessed 2 June 2014).
31. Anonymous . Erratum: Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: Three year randomized trial results (Ophthalmology 2012;119:2312-8). Ophthalmology 2014;121(3):805.
32. Lang GE, Berta A, Eldem BM, Simader C, Sharp D, Holz FG, et al.Two-year safety and efficacy of ranibizumab 0.5 mg in diabetic macular edema: interim analysis of the RESTORE extension study. Ophthalmology 2013; Vol. 120, issue 10:2004-12.
33. Mitchell P, Annemans L, Gallagher M, Hasan R, Thomas S, Gairy K, et al.Cost-effectiveness of ranibizumab in treatment of diabetic macular oedema (DME) causing visual impairment: evidence from the RESTORE trial. British Journal of Opthalmology 2012; Vol. 96, issue 5:688-93.
34. Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, et al.The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology 2011;118(4):615-62.
35. Mitchell P, Bressler N, Tolley K, Gallagher M, Petrillo J, Ferreira A, et al.Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: randomized clinical trial. JAMA Ophthalmology 2013;131(10):1339-47.
36. Schmidt-Erfurth U, Lang GE, Holz FG, Schlingemann RO, Lanzetta P, Massin P, et al.Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study. Ophthalmology 2014;121(5):1045-53.
37. Brown DM, Nguyen QD, Marcus DM, Boyer DS, Patel S, Feiner L, et al.Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology 2013;120(10):2013-22.
38. Ip MS, Domalpally A, Hopkins JJ, Wong P, Ehrlich JS. Long-term effects of ranibizumab on diabetic retinopathy severity and progression. Archives of Ophthalmology 2012;130(9):1145-52.
39. Mieler WF, Kim JE, Yau L, Ehrlich JS. Earlier treatment is important in diabetic macular edema: Outcomes from phase III trials of intravitreal ranibizumab. 73rd Scientific sessions of the American Diabetes Association; 2013 Jun 21-25; Chicago. 2013.
40. Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L, et al.Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 2012;119(4):789-801.
41. Soheilian M, Garfami KH, Ramezani A, Yaseri M, Peyman GA. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina 2012;32(2):314-21.
42. Soheilian M, Ramezani A, Bijanzadeh B, Yaseri M, Ahmadieh H, Dehghan MH, et al.Intravitreal bevacizumab (avastin) injection alone or combined with triamcinolone versus macular photocoagulation as primary treatment of diabetic macular edema. Retina 2007;27(9):1187-95.
43. Soheilian M, Ramezani A, Obudi A, Bijanzadeh B, Salehipour M, Yaseri M, et al.Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology 2009;116(6):1142-50.
44. Ahmadieh H, Nourinia R, Hafezi-Moghadam A. Intravitreal fasudil combined with bevacizumab for persistent diabetic macular edema. JAMA Ophthalmology 2013;131(7):923-4.
45. CRFB002DFR08 . Open-label, multicenter, study of the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting a visual impairment due to diabetic macular edema in current medical practice (LUDIC). Novartis clinical trial results database www.novctrd.com/ctrdWebApp/clinicaltrialrepository/public/products.jsp?divisionId=2&diseaseAreaID=12 (accessed 28 May 2014).
46. CRFB002DGB14 . RELIGHT - Ranibizumab treatment of diabetic macular oEdema with bimonthLy monItorinG after a pHase of initial Treatment. A UK, 18-month, prospective, open-label, multicentre, single-arm Phase IIIb study, with 12-month primary endpoint, assessing the efficacy and safety of Ranibizumab in patients with visual impairment. Novartis clinical trial results database www.novctrd.com/ctrdWebApp/clinicaltrialrepository/public/products.jsp?divisionId=2&diseaseAreaID=12 (accessed 28 May 2014).
47. CRFB002DNO02 . An open-label, prospective, multicenter, uncontrolled, Proof of concept study assessing the efficacy of Lucentis (ranibizumab) administered by an individualized "treat and extend" dosing regimen in patients with visual impairment due to dIabetic macular edema. Novartis clinical trial results database www.novctrd.com/ctrdWebApp/clinicaltrialrepository/public/products.jsp?divisionId=2&diseaseAreaID=12 (accessed 28 May 2014).
48. Diabetic Retinopathy Clinical Research Network, Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK, et al.A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology 2007;114(10):1860-7.
49. Diabetic Retinopathy Clinical Research Network, Googe J, Brucker AJ, Bressler NM, Qin H, Aiello LP, et al.Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal/grid laser for diabetic macular edema in eyes also receiving panretinal photocoagulation. Retina 2011;31(6):1009-27.
50. Diabetic Retinopathy Clinical Research Network, Elman MJ, Qin H, Aiello LP, Beck RW, Bressler NM, et al.Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results. Ophthalmology 2012; Vol. 119, issue 11:2312-8.
51. Faghihi H, Roohipoor R, Mohammadi SF, Hojat-Jalali K, Mirshahi A, Lashay A, et al.Intravitreal bevacizumab versus combined bevacizumab-triamcinolone versus macular laser photocoagulation in diabetic macular edema. European Journal of Ophthalmology 2008;18(6):941-8.
52. Lim JW, Lee HK, Shin MC. Comparison of intravitreal bevacizumab alone or combined with triamcinolone versus triamcinolone in diabetic macular edema: a randomized clinical trial. Ophthalmologica 2012;227(2):100-6.
53. Paccola L, Costa RA, Folgosa MS, Barbosa JC, Scott IU, Jorge R. Intravitreal triamcinolone versus bevacizumab for treatment of refractory diabetic macular oedema (IBEME study). British Journal of Ophthalmology 2008;92(1):76-80.
54. Solaiman KA, Diab MM, Abo-Elenin M. Intravitreal bevacizumab and/or macular photocoagulation as a primary treatment for diffuse diabetic macular edema. Retina 2010;30(10):1638-45.
55. Zehetner C, Kirchmair R, Huber S, Kralinger MT, Kieselbach GF. Plasma levels of vascular endothelial growth factor before and after intravitreal injection of bevacizumab, ranibizumab and pegaptanib in patients with age-related macular degeneration, and in patients with diabetic macular oedema. British Journal of Ophthalmology 2013;97(4):454-9.
56. Zhang LW, Su KX, Ma J, Qiu H, Wei XH. Investigation on effects of intravitreal injection of bevacizumab and triamcinolone acetonide for diabetes macular edema. International Eye Science 2013;13:798-800.
57. CRFB002DD13 . A 2-year randomized, single-masked, multicenter, controlled phase IIIb trial assessing the efficacy and safety of 0.5mg ranibizumab in two "treat and extend" treatment algorithms versus 0.5mg ranibizumab as needed in patients with macular edema and visual impairment secondary to Diabetes mellitus. Novartis clinical trial results database www.novctrd.com/ctrdWebApp/clinicaltrialrepository/public/login.jsp (accessed 2 June 2014).
58. NCT01171976 . Efficacy and safety of ranibizumab in two "Treat and Extend" treatment algorithms versus ranibizumab as needed in patients with macular edema and visual impairment secondary to diabetes mellitus (RETAIN). clinicaltrials.gov/ct2/show/NCT01171976 (accessed 2 June 2014).
59. ChiCTR-TRC-12002417 . A randomized controlled trial to compare the efficacy and safety of 1) macular laser vs. 2) repeated intravitreal bevacizumab vs. 3) combined repeated intravitreal bevacizumab with macular laser for diabetic macular edema. www.chictr.org/en/proj/show.aspx?proj=3294 (accessed 17 September 2014).
60. NCT00387582 . Efficacy study of lucentis in the treatment of diabetic macular edema - a phase II, single center, randomized study to evaluate the efficacy of ranibizumab versus focal laser treatment in subjects with diabetic macular edema. clinicaltrials.gov/show/NCT00387582 (accessed 15 October 2012).
61. NCT00901186 . A randomized, open label, multicenter, laser-controlled phase II study assessing the efficacy and safety of ranibizumab (intravitreal Injections) vs. laser treatment in patients with visual impairment due to diabetic macular edema. clinicaltrials.gov/show/NCT00901186 (accessed 15 October 2012).
62. NCT00989989 . A randomized, double-masked, multicenter, laser controlled phase III study assessing the efficacy and safety of ranibizumab in patients with diabetic macular edema. clinicaltrials.gov/show/NCT00989989 (accessed 15 October 2012).
63. NCT00997191 . Intravitreal bevacizumab and intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema (IBeTA). clinicaltrials.gov/show/NCT00997191 (accessed 15 Oct 2012).
64. NCT01100307 . A phase 3, randomized, controlled, double-masked, multi-center, comparative, in parallel roups (for 24 weeks), to compare the efficacy and safety of 0.3 mg pegaptanib sodium, with sham injections, and open study (for 30 weeks) to confirm the safety of 0.3 mg pegaptanib sodium in subjects with diabetic macular edema (DME). clinicaltrials.gov/show/NCT01100307 (accessed 15 October 2012).
65. NCT01100401 . Ranibizumab for edema of the macula in diabetes: protocol 3 with high dose - the READ 3 study. clinicaltrials.gov/show/NCT01077401 (accessed on 15 October 2012).
66. NCT01112085 . Phase 2 study of microdoses of ranibizumab in diabetic macular edema - the MINIMA 2 study. clinicaltrials.gov/show/NCT01112085 (accessed 15 October 2012).
67. NCT01445899 . An open-label dose escalation study of PF-04523655 (Stratum I) combined with a prospective, randomized, double-masked, multi-center, controlled study (Stratum II) evaluating the efficacy and safety of PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in diabetic macular edema (MATISSE STUDY). clinicaltrials.gov/ct2/show/study/NCT01445899 (accessed 15 October 2012).
68. NCT01476449 . Monthly ranibizumab versus treat and extend ranibizumab for diabetic macular edema. clinicaltrials.gov/ct2/show/NCT01476449 (accessed 15 October 2012).
69. NCT01487629 . Bevacizumab versus ranibizumab for the treatment of diabetic macular edema. clinicaltrials.gov/ct2/show/study/NCT01487629 (accessed 15 October 2012).
70. NCT01552408 . A phase I/II, randomized, study for diabetic macular edema using 0.3mg ranibizumab combined with targeted PRP monthly for 4 months, then PRN vs. 0.3mg ranibizumab 4 months monotherapy, then as needed (DME-AntiVEgf) DAVE. clinicaltrials.gov/ct2/show/study/NCT01552408 (accessed 15 October 2012).
71. NCT01565148 . A randomized, multi-center, phase II study of the safety, tolerability, and bioactivity of repeated intravitreal injections of iCo-007 as monotherapy or in combination with ranibizumab or laser photocoagulation in the treatment of diabetic macular edema with involvement of the foveAL center (the iDEAL Study). clinicaltrials.gov/ct2/show/study/NCT01565148 (accessed 15 October 2012).
72. NCT01572350 . Randomized multicenter clinical trial of three parallel groups to estimate the safety and efficacy of triamcinolone acetonide combined with laser, bevacizumab combined with laser versus laser alone for the treatment of diffuse non-tractional diabetic macular edema. clinicaltrials.gov/ct2/show/study/NCT01572350 (accessed 15 October 2012).
73. NCT01610557 . A phase II randomized study to compare anti-VEGF agents in the treatment of diabetic macular edema (CADME). clinicaltrials.gov/ct2/show/study/NCT01610557 (accessed 15 October 2012).
74. NCT01627249 . A comparative effectiveness study of intravitreal aflibercept, bevacizumab and ranibizumab for diabetic macular edema. clinicaltrials.gov/ct2/show/study/NCT01627249 (accessed 15 October 2012).
75. NCT01635790 . Comparing the effectiveness and costs of bevacizumab to ranibizumab in patients with diabetic macular edema (BRDME). ClinicalTrials.gov/show/NCT01635790 (accessed 17th September 2014).
76. NCT01845844 . Ranibizumab for persistent diabetic macular edema after bevacizumab (ROTATE). clinicaltrials.gov/show/NCT01845844 (accessed 17th September 2014).
77. Abouammoh MA. Ranibizumab injection for diabetic macular edema: meta-analysis of systemic safety and systematic review. Canadian Journal of Ophthalmology 2013;48(4):317-23.
78. Aiello LP. Angiogenic pathways in diabetic retinopathy. New England Journal of Medicine 2005;353(8):839-41.
79. Antcliff RJ, Marshall J. The pathogenesis of edema in diabetic maculopathy. Seminars in Ophthalmology 1999;14(4):223-32.
80. Arevalo JF, Fromow-Guerra J, Quiroz-Mercado H, Sanchez JG, Wu L, Maia M, 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 2007;114(4):743-50.
81. Arevalo JF, Garcia-Amaris RA. Intravitreal bevacizumab for diabetic retinopathy. Current Diabetes Reviews 2009;5(1):39-46.
82. Aroca PR, Salvat M, Fernandez J, Mendez I. Risk factors for diffuse and focal macular edema. Journal of Diabetic Complications 2004;18(4):211-5.
83. Anonymous . 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. Antiplatelet Trialists' Collaboration. BMJ 1994;308(6921):81-106.
84. Avery RL, Pieramici DJ, Rabena MD. Intravitreal bevacizumab (Avastin) for neovascular age related macular degeneration. Ophthalmology 2006;113(3):363-72.
85. Borm GF, Lemmers O, Fransen J, Donders R. The evidence provided by a single trial is less reliable than its statistical analysis suggests. Journal of Clinical Epidemiology 2009;62(7):711-5.
86. Boscia F. Current approaches to the management of diabetic retinopathy and diabetic macular oedema. Drugs 2010;70(16):2171-200.
87. Bresnick GH, Engerman R, Davis MD, de Venecia G, Myers FL. Patterns of ischemia in diabetic retinopathy. Transactions. Section on Ophthalmology. American Academy of Ophthalmology and Otolaryngology 1976;81(4 Pt 1):OP694-709.
88. Bresnick GH. Diabetic maculopathy: a critical review highlighting diffuse macular edema. Ophthalmology 1983;90(11):1301-17.
89. Bresnick GH, Condit R, Syriala S, Palta M, Groo A, Korth K. Abnormalities of the foveal avascular zone in diabetic retinopathy. Archives of Ophthalmology 1984;102(9):1286-93.
90. Bressler NM, Boyer DS, Williams DF, Butler S, Francom SF, Brown B, et al.Cerebrovascular accidents in patients treated for choroidal neovascularization with ranibizumab in randomized controlled trials. Retina 2012;32(9):1821-8.
91. Brown JC, Solomon SD, Bressler SB, Schachat AP, DiBernardo C, Bressler NM. Detection of diabetic foveal edema: contact lens biomicroscopy compared with optical coherence tomography. Archives of Ophthalmology 2004;122(3):330-5.
92. Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, et al.Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology 2010;117(6):1124-33.
93. Brown DM, Campochiaro PA, Bhisitkul RB, Ho AC, Gray S, Saroj N, 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):1594-602.
94. Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, et al.Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology 2010;117(6):1102-12.
95. Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, 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):2041-9.
96. CATT Research Group, Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, et al.Ranibizumab and bevacizumab for neovascular age-related macular degeneration. New England Journal of Medicine 2011;364(20):1897-908.
97. Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group, Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, et al.Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 2012;119(7):1388-98.
98. Ciulla TA, Amador AG, Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies. Diabetes Care 2003;26(9):2653-64.
99. Ciulla TA, Walker JD, Fong DS, Criswell MH. Corticosteroids in posterior segment disease: an update on new delivery systems and new indications. Current Opinions in Ophthalmology 2004;15(3):211-20.
100. Cunha-Vaz J. Diabetic macular edema. European Journal of Ophthalmology 1998;8(3):127-30.
101. Cunningham ET Jr, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ, et al.A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 2005;112(10):1747-57.
102. Deeks JJ, Higgins JPT, Altman DG (editors). Chapter 9: Analysing data and undertaking meta-analyses. In: Higgins JPT, Green S (editors). In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
103. Elman MJ, Qin H, Aiello LP, Beck RW, Bressler NM, Ferris FL 3rd, et al.Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results. Ophthalmology 2012;119(11):2312-8.
104. Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Archives of Ophthalmology 1985;103(12):1796-806.
105. Ferrara N, Hillan KJ, Gerber HP, Novotny W. Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer. Nature Reviews. Drug Discovery 2004;3(5):391-400.
106. Ferrara N, Damico L, Shams N, Lowman H, Kim R. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina 2006;26(8):859-70.
107. Ferris FL 3rd, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Archives of Ophthalmology 1984;102(11):1640-2.
108. Ford JA, Elders A, Shyangdan D, Royle P, Waugh N. The relative clinical effectiveness of ranibizumab and bevacizumab in diabetic macular oedema: an indirect comparison in a systematic review. BMJ 2012;345:e5182.
109. Frank RN. Diabetic retinopathy. New England Journal of Medicine 2004;350(1):48-58.
110. Glanville JM, Lefebvre C, Miles JN, Camosso-Stefinovic J. How to identify randomized controlled trials in MEDLINE: ten years on. Journal of the Medical Library Association 2006;94(2):130-6.
111. Goyal S, Lavalley M, Subramanian ML. Meta-analysis and review on the effect of bevacizumab in diabetic macular edema. Graefe's Archive for Clinical and Experimental Ophthalmology 2011;249(1):15-27.
112. Gragoudas ES, Adamis AP, Cunningham ET Jr. Feinsod M, Guyer DR, VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for neovascular age-related macular degeneration. New England Journal of Medicine 2004;351(27):2805-16.
113. Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database of Systematic Reviews 2008, Issue 1. [DOI: 10.1002/14651858.CD005656.pub2]
114. Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al.GRADE guidelines 6. Rating the quality of evidence-imprecision. Journal of Clinical Epidemiology 2011;64(12):1283-93.
115. Haller JA, Kuppermann BD, Blumenkranz MS, Williams GA, Weinberg DV, Chou C, et al.Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Archives of Ophthalmology 2010;128(3):289-96.
116. Harbour JW, Smiddy WE, Flynn HW Jr, Rubsamen RE. Vitrectomy for diabetic macular edema associated with a thickened and taut posterior hyaloid membrane. American Journal of Ophthalmology 1996;121(4):405-13.
117. Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, et al.The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology 2011;118(6):1098-106.
118. Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
119. Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
120. Ho AC, Scott IU, Kim S, Brown GC, Brown MM, Ip MS, et al.Anti-vascular endothelial growth factor pharmacotherapy for diabetic macular edema: a report by the American Academy of Ophthalmology. Ophthalmology 2012;119(10):2179-88.
121. Iturralde D Spaide RF, Meyerle CB, Klancnik JM, Yannuzzi LA, Fisher YL, et al.Intravitreal bevacizumab (Avastin) treatment of macular edema in central retina vein occlusion: a short-term study. Retina 2006;26(3):279-84.
122. Jampol LM, Bressler NM, Glassman AR. Revolution to a new standard treatment of diabetic macular edema. JAMA 2014;311(22):2269-70.
123. Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology 1984;91(12):1464-74.
124. Kuppermann BD, Chou C, Weinberg DV, Whitcup SM, Haller JA, Blumenkranz MS. Intravitreous dexamethasone effects on different patterns of diabetic macular edema. Archives of Ophthalmology 2010;128(5):642-3.
125. Kylstra JA, Brown JC, Jaffe GJ, Cox TA, Gallemore R, Greven CM, et al.The importance of fluorescein angiography in planning laser treatment of diabetic macular edema. Ophthalmology 1999;106(11):2068-73.
126. Ladas ID, Theodossiadis GP. Long-term effectiveness of modified grid laser photocoagulation for diffuse diabetic macular edema. Acta Ophthalmologica 1993;71(3):393-7.
127. Lee CM, Olk RJ. Modified grid laser photocoagulation for diffuse diabetic macular edema. Long-term visual results. Ophthalmology 1991;98(10):1594-602.
128. Lewis H, Abrams GW, Blumenkranz MS, Campo RV. Vitrectomy for diabetic macular traction and edema associated with posterior hyaloidal traction. Ophthalmology 1992;99(5):753-9.
129. Manousaridis K, Talks J. Macular ischaemia: a contraindication for anti-VEGF treatment in retinal vascular disease?. British Journal of Ophthalmology 2012;96(2):179-84.
130. Anti-vascular endothelial growth factor treatment for diabetic macular edema. www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=85&bc=AAAQAAAAAAAA& (accessed 24 Sept 2012).
131. Moja L, Lucenteforte E, Kwag KH, Bertele V, Campomori A, Chakravarthy U, et al.Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database of Systematic Reviews 2014, Issue 9. [DOI: 10.1002/14651858.CD011230.pub2]
132. Nicholson BP, Schachat AP. A review of clinical trials of anti-VEGF agents for diabetic retinopathy. Graefe's Archive for Clinical and Experimental Ophthalmology 2010;248(7):915-30.
133. O'Malley PG. Comparative effectiveness of anti-growth factor therapies for diabetic macular edema: summary of primary findings and conclusions. Archives of Internal Medicine 2012;172(13):1014-5.
134. O'Doherty M, Dooley I, Hickey-Dwyer M. Interventions for diabetic macular oedema: a systematic review of the literature. British Journal of Ophthalmology 2008;92(12):1581-90.
135. Ogura Y, Roider J, Korobelnik JF, Holz FG, Simader C, Schmidt-Erfurth U, et al.Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. American Journal of Ophthalmology 2014 Jul 25 [Epub ahead of print].
136. Olson J, Sharp P, Goatman K, Prescott G, Scotland G, Fleming A, et al.Improving the economic value of photographic screening for optical coherence tomography-detectable macular oedema: a prospective, multicentre, UK study. Health Technology Assessment 2013;17(51):1-142.
137. Medical Advisory Secretariat. Optical coherence tomography for age-related macular degeneration and diabetic macular edema: an evidence-based analysis. Ontario Health Technology Assessment Series 2009;9(13):1-22.
138. Pagliarini S, Beatty S, Lipkova B, Perez-Salvador Garcia E, Reynders S, Gekkieva M, et al.A 2-year, phase IV, multicentre, observational study of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration in routine clinical practice: The EPICOHORT study. Journal of Ophthalmology 2014;2014:857148.
139. Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, Krummen L, et al.Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Research 1997;57(20):4593-9.
140. Regnier S, Malcolm W, Allen F, Wright J, Bezlyak V. Efficacy of anti-VEGF and laser photocoagulation in the treatment of visual impairment due to diabetic macular edema: a systematic review and network meta-analysis. PloS ONE 2014;9(7):e102309.
141. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
142. Rosenfeld PJ, Rich RM, Lalwani GA. Ranibizumab: Phase III clinical trial results. Ophthalmology Clinics of North America 2006;19(3):361-72.
143. Salam A, DaCosta J, Sivaprasad S. Anti-vascular endothelial growth factor agents for diabetic maculopathy. British Journal of Ophthalmology 2010;94(7):821-6.
144. Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, et al.Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology 2014;121(1):193-201.
145. Schmucker C, Ehlken C, Agostini HT, Antes G, Ruecker G, Lelgemann M, et al.A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus gold standard. PLoS ONE 2012;7(8):e42701.
146. Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ, Glasziou P, et al.Chapter 12: Interpreting results and drawing conclusions.In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
147. Simmonds MC, Higgins JP. A general framework for the use of logistic regression models in meta-analysis. Statistical Methods in Medical Research 2014 May 12 [Epub ahead of print].
148. Smiddy WE. Economic considerations of macular edema therapies. Ophthalmology 2011;118(9):827-33.
149. Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database of Systematic Reviews 2014, Issue 8. [DOI: 10.1002/14651858.CD005139.pub3]
150. Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina 2006;26(3):275-8.
151. Ticho U, Patz A. The role of capillary perfusion in the management of diabetic macular edema. American Journal of Ophthalmology 1973;76(6):880-6.
152. Tranos PG, Wickremasinghe SS, Stangos NT, Topouzis F, Tsinopoulos I, Pavesio CE. Macular edema. Survey of Ophthalmology 2004;49(5):470-90.
153. Wang H, Sun X, Liu K, Xu X. Intravitreal ranibizumab (lucentis) for the treatment of diabetic macular edema: a systematic review and meta-analysis of randomized clinical control trials. Current Eye Research 2012;37(8):661-70.
154. White IR, Higgins JP, Wood AM. Allowing for uncertainty due to missing data in meta-analysis - Part 1. Two-stage methods. Statistics in Medicine 2008;27(5):711-27.
155. Williams R, Airey M, Baxter H, Forrester J, Kennedy-Martin T, Girach A. Epidemiology of diabetic retinopathy and macular oedema: a systematic review. Eye 2004;18(10):963-83.
156. Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al.The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 2010;340:c365.
157. Yanagida Y, Ueta T. Systemic safety of ranibizumab for diabetic macular edema: meta-analysis of randomized trials. Retina 2014;34(4):629-35.
158. Zechmeister-Koss I, Huic M. Vascular endothelial growth factor inhibitors (anti-VEGF) in the management of diabetic macular oedema: a systematic review. British Journal of Ophthalmology 2012;96(2):167-78.
159. Parravano M, Menchini F. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD007419]
160. Parravano M, Menchini F, Virgili G. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD007419.pub2]
161. Virgili G, Parravano M, Menchini F, Brunetti M. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema. Cochrane Database of Systematic Reviews 2012, Issue 12. [DOI: 10.1002/14651858.CD007419.pub3]