Long-term effectiveness of ranibizumab for age-related macular degeneration and diabetic macular edema

Clinical Interventions in Aging

Volumn 8, Issue , 2013, Pages 467-483

  Fong, Angie H C ^a   Lai, Timothy Y Y ^a,b  

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^b 2010 Retina and Macula Centre   (Hong Kong)

Author keywords

Age related macular degeneration; Anti VEGF therapy; Cost effectiveness; Diabetic macular edema; Diabetic retinopathy; Ranibizumab; Safety

Indexed keywords

AFLIBERCEPT; BEVACIZUMAB; PEGAPTANIB; PLACEBO; RANIBIZUMAB; TRIAMCINOLONE ACETONIDE; VASCULOTROPIN A;

AMINO ACID SUBSTITUTION; ARTERIAL THROMBOEMBOLISM; CARDIOVASCULAR DISEASE; CATARACT; CEREBROVASCULAR ACCIDENT; COST EFFECTIVENESS ANALYSIS; DIABETIC MACULAR EDEMA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG COST; DRUG DISTRIBUTION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ELIMINATION; DRUG FATALITY; DRUG HALF LIFE; DRUG PENETRATION; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; ENDOPHTHALMITIS; EYE DISEASE; EYE INFLAMMATION; GASTROINTESTINAL DISEASE; GLAUCOMA; HEART FAILURE; HEART INFARCTION; HUMAN; HYPERTENSION; INFECTION; INTRAOCULAR PRESSURE; LENS DAMAGE; LENS DISEASE; LOADING DRUG DOSE; LOW LEVEL LASER THERAPY; MONOTHERAPY; MULTICENTER STUDY (TOPIC); NONHUMAN; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PSEUDOENDOPHTHALMITIS; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETINA ARTERY OCCLUSION; RETINA DETACHMENT; RETINA HEMORRHAGE; RETINA ISCHEMIA; RETINA MACULA AGE RELATED DEGENERATION; RETINA MACULA EDEMA; RETINA TEAR; REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; SUBRETINAL NEOVASCULARIZATION; UVEITIS; VISUAL ACUITY; VITREOUS HEMORRHAGE;

AGE-RELATED MACULAR DEGENERATION; ANTI-VEGF THERAPY; COST-EFFECTIVENESS; DIABETIC MACULAR EDEMA; DIABETIC RETINOPATHY; RANIBIZUMAB; SAFETY;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; CLINICAL TRIALS AS TOPIC; DIABETIC RETINOPATHY; HUMANS; MACULAR DEGENERATION; MACULAR EDEMA;

EID: 84876964702     PISSN: 11769092     EISSN: 11781998     Source Type: Journal    
DOI: 10.2147/CIA.S36811     Document Type: Review

References (61)

1. Smith W, Assink J, Klein R, et al. Risk factors for age-related macular degeneration: pooled findings from three continents. Ophthalmology. 2001;108(4):697-704.
2. Cheung CM, Tai ES, Kawasaki R, et al. Prevalenec of and risk factors for age-related macular degeneration in a multiethnic Asian cohort. Arch Ophthalmol. 2012;130(4):480-486.
3. Klein R, Klein BE, Knudtson MD, Meuer SM, Swift M, Gangnon RE. Fifteen-year cumulative incidence of age-related macular degeneration: the Beaver Dam Eye Study. Ophthalmology. 2007;114(2):253-262.
4. Wong TY, Chakravarthy U, Klein R, et al. The natural history and prognosis of neovascular age-related macular degeneration: a systematic review of the literature and meta-analysis. Ophthalmology. 2008;115(1): 116-126.
5. 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):859-870.
6. Lopez PF, Sippy BD, Lambert HM, et al. Transdifferentiated retinal pigment epithelial cells are immunoreactive for vascular endothelial growth factor in surgically excised age-related macular degeneration-related choroidal neovascular membranes. Invest Ophthalmol Vis Sci. 1996;37(5):855-868.
7. Donoso LA, Kim D, Frost A, et al. The role of inflammation in the pathogenesis of age-related macular degeneration. Surv Ophthalmol. 2006;51(2):137-152.
8. Chan WM, Lai TY, Tano Y, Liu DT, Li KK, Lam DS. Photodynamic therapy in macular diseases of asian populations: when East meets West. Jpn J Ophthalmol. 2006;50(2):161-169.
9. Bressler NM. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: two-year results of 2 randomized clinical trials-tap report 2. Arch Ophthalmol. 2001;119(2):198-207.
10. Bressler NM. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: two-year results of a randomized clinical trial including lesions with occult with no classic choroidal neovascularization-verteporfin in photodynamic therapy report 2. Am J Ophthalmol. 2002;133(1):168-169.
11. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009;116(1):57-65. e55.
12. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14): 1419-1431.
13. Regillo CD, Brown DM, Abraham P, et al. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol. 2008;145(2):239-248.
14. Lalwani GA, Rosenfeld PJ, Fung AE, et al. A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol. 2009;148(1):43-58.
15. Holz FG, Amoaku W, Donate J, et al. Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the SUSTAIN study. Ophthalmology. 2011;118(4):663-671.
16. Singer MA, Awh CC, Sadda S, et al. HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology. 2012;119(6): 1175-1183.
17. CATT Research Group, Martin DF, Maguire MG, et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011;364(20):1897-1908.
18. Chakravarthy U, Harding SP, Rogers CA, et al. Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology. 2012;119(7):1399-1411.
19. Yau JW, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35(3):556-564.
20. Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010;376(9735):124-136.
21. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985;103(12): 1796-1806.
22. Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2008;1:CD005656.
23. Do DV, Nguyen QD, Khwaja AA, et al. Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment. Arch Ophthalmol. 2013;131(2):139-145.
24. Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012;119(4):789-801.
25. Nguyen QD, Shah SM, Heier JS, 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):2175-2181.
26. Nguyen QD, Shah SM, Khwaja AA, et al. Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology. 2010;117(11):2146-2151.
27. Massin P, Bandello F, Garweg JG, 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):2399-2405.
28. Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118(4):615-625.
29. Elman MJ, Qin H, Aiello LP, et al. Intravitreal ranibizumab for diabetic Macular edema with prompt versus deferred laser treatment: three-year randomized trial results. Ophthalmology. 2012;119(11):2312-2318.
30. Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocr Rev. 2004;25(4):581-611.
31. Stewart MW. The expanding role of vascular endothelial growth factor inhibitors in ophthalmology. Mayo Clin Proc. 2012;87(1):77-88.
32. 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. N Engl J Med. 2004;351(27):2805-2816.
33. Blick SK, Keating GM, Wagstaff AJ. Ranibizumab. Drugs. 2007; 67(8):1199-1206.
34. Kim KJ, Li B, Winer J, et al. Inhibition of vascular endothlial growth factor-induced angiogenesis suppresses tumor growth in vivo. Nature. 1993;362(6423):841-844.
35. Presta LG, Chen H, O'Connor SJ, et al. Humanization of an anti-VEGF monoclonal antibody for the therapy of solid tumours and other disorders. Cancer Res. 1997;57(20):4593-4599.
36. Ferrara N, Kerbel RS. Angiogenesis as a therapeutic agent. Nature 2005;438(7070):967-974.
37. Frampton JE. Ranibizumab: in diabetic macular oedema. Drugs. 2012;72(4):509-523.
38. Lowe J, Araujo J, Yang J, et al. Ranibizumab inhibits multiple forms of biologically active vascular endothelial growth factor in vitro and in vivo. Exp Eye Res. 2007;85(4):425-430.
39. Gaudreault J, Fei D, Rusit J, Suboc P, Shiu V. Preclinical pharmacokinetics of Ranibizumab (rhuFabV2) after a single intravitreal administration. Invest Ophthalmol Vis Sci. 2005;46(2):726-733.
40. Gaudreault J, Fei D, Beyer JC, et al. Pharmacokinetics and retinal distribution of ranibizumab, a humanized antibody fragment directed against VEGF-A, following intravitreal administration in rabbits. Retina. 2007;27(9):1260-1266.
41. Krohne TU, Liu Z, Holz FG, Meyer CH. Intraocular pharmacokinetics of ranibizumab following a single intravitreal injection in humans. Am J Ophthalmol. 2012;154(4):682-686
42. Xu L, Lu T, Tuomi L, et al. Pharmacokinetics of ranibizumab in patients with neovascular age-related macular degeneration - a population approach. Invest Ophthalmol Vis Sci. 2013;54(3):1616-1624.
43. Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovacsular age-related macular degeneration. Ophthalmology. 2009;116(9):1731-1739.
44. Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology. 2012;119(7):1388-1398.
45. Schmucker C, Ehlken C, Agostini HT, et al. A safety review and meta-analyses of bevaizumab and ranibizumab: off-label versus gold standard. PLoS ONE. 2012;7(8):e42701.
46. Mitchell P; RESTORE extension study group. 2-year safety and efficacy outcome of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME): an interim analysis of the RESTORE extension study. Invest Ophthalmol Vis Sci. 2012;53:ARVO E-abstract 4667.
47. Ohji M, Ishibashi T; REVEAL study group. Efficacy and safety of ranibizumab 0.5 mg as monotherapy or adjunctive to laser versus laser monotherapy in Asian patients with visual impairment due to diabetic macular edema: 12-month results of the REVEAL study. Invest Ophthalmol Vis Sci. 2012;53:ARVO E-abstract 4664.
48. Elman MJ, Aiello LP, Beck RW, et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010;117(6): 1064-1077. e1035.
49. Elman MJ, Bressler NM, Qin H, 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):609-614.
50. Mitchell P, Annemans L, White R, Gallagher M, Thomas S. Cost effectiveness of treatments for wet age-related macular degeneration. Pharmacoeconomics. 2011;29(2):107-131.
51. Colquitt JL, Jones J, Tan SC, Takeda A, Clegg AJ, Price A. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration: a systematic review and economic evaluation. Health Technol Assess. 2008;12(16):iii-iv,ix-201.
52. Neubauer AS, Holz FG, Sauer S, et al. Cost-effectiveness of ranibizumab for the treatment of neovascular age-related macular degeneration in Germany: model analysis from the perspective of Germany's statutory health insurance system. Clin Ther. 2010;32(7):1343-1356.
53. Mitchell P, Annemans L, Gallagher M, et al. Cost-effectiveness of ranibizumab in treatment of diabetic macular oedema (DME) causing visual impairment: evidence from the RESTORE trial. Br J Ophthalmol. 2012;96(5):688-693.
54. Bressler NM, Chang TS, Fine JT, Dolan CM, Ward J. Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial. Arch Ophthalmol. 2009;127(1):13-21.
55. Bressler NM, Chang TS, Suner IJ, et al. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology. 2010;117(4): 747-756.
56. Bressler NM, Chang TS, Varma R, et al. Driving ability reported by beovascular age-related macular degeneration patients after treatment with ranibizumab. Ophthalmology. 2013;120(1):160-168.
57. Frennesson C, Nilsson UL, Peebo BB, Nilsson SE. Significant improvements in near vision, reading speed, central visual field and related quality of life after ranibizumab treatment of wet age-related macular degeneration. Acta Ophthalmol. 2010;88(4):420-425.
58. Bandello F, Holz FG, Gillies MC, Koh A, Mitchell P; LUMINOUS group, Safety, efficacy, treatment patterns of ranibizumab therapy for neovascular age-related macular degneration: the LUMINOUS studies. Invest Ophthalmol Vis Sci. 2012;53:ARVO E-abstract 2031.
59. Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-2548.
60. Chaikitmongkol V, Bressler NM. Dramatic resolution of choroidal neovascular abnormalities after single aflibercept injection following years of ranibizumab use. JAMA Ophthalmol. 2013;131(2):260-262.
61. European Medicines Agency. Eylea: EPAR - public assessment report. EMA/646256/2012 corr. September 20, 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002392/WC500135744.pdf. Accessed April 17, 2013.