Treatment for neovascular age related macular degeneration: The state of the art

European Journal of Pharmacology

Volumn 787, Issue , 2016, Pages 78-83

  Eandi, Chiara M ^a   Alovisi, Camilla ^a   De Sanctis, Ugo ^a   Grignolo, Federico M ^a  

^a UNIVERSITY OF TURIN   (Italy)

Author keywords

Angiogenesis; Anti VEGF; Choroid; Degeneration; Macula; Retina

Indexed keywords

AFLIBERCEPT; BEVACIZUMAB; PEGAPTANIB; RANIBIZUMAB; VASCULOTROPIN A;

AGE RELATED MACULAR DEGENERATION; ARTICLE; CARDIOVASCULAR RISK; CLINICAL PRACTICE; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; TREATMENT INDICATION; ADVERSE EFFECTS; ANIMAL; BLOOD VESSEL; CLINICAL TRIAL (TOPIC); DRUG EFFECTS; MACULAR DEGENERATION; METABOLISM; MOLECULARLY TARGETED THERAPY; PATHOPHYSIOLOGY; PROCEDURES; SAFETY;

ANIMALS; BLOOD VESSELS; CLINICAL TRIALS AS TOPIC; HUMANS; MACULAR DEGENERATION; MOLECULAR TARGETED THERAPY; SAFETY; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84959541827     PISSN: 00142999     EISSN: 18790712     Source Type: Journal    
DOI: 10.1016/j.ejphar.2016.03.002     Document Type: Article

References (75)

1. Abedi, F., et al. Anti-VEGF treatment in neovascular age-related macular degeneration: a treat-and-extend protocol over 2 years. Retina 34:8 (2014), 1531–1538, 10.1097/IAE.0000000000000134.
2. Avery, R.L., et al. Intravitreal Bevacizumab (Avastin) for Neovascular age-related macular degeneration. Ophthalmology 113:3 (2006), 363–372.e5.
3. Avery, R.L., et al. What is the evidence for systemic effects of Intravitreal anti-VEGF Agents, and should we be concerned?. Br. J. Ophthalmol., 98(1), 2014, 10.1136/bjophthalmol-2013-303844.
4. Bakall, B., et al. Aflibercept therapy for exudative age-related macular degeneration resistant to Bevacizumab and Ranibizumab. Am. J. Ophthalmol., 156(1), 2013, 10.1016/j.ajo.2013.02.017.
5. Berg, K., et al. Ranibizumab or Bevacizumab for Neovascular age-related macular degeneration according to the Lucentis compared to Avastin study treat-and-extend protocol: two-year results. Ophthalmology, 2015, 10.1016/j.ophtha.2015.09.018 pii: S0161-6420(15)01040-4.
6. Bloch, S.B., et al. Incidence of legal Blindness from age-related macular degeneration in Denmark: year 2000 to 2010. Am. J. Ophthalmol. 153:2 (2012), 209–213, 10.1016/j.ajo.2011.10.016.
7. Bourne, R.R., et al. Prevalence and Causes of vision loss in high-income countries and in eastern and central Europe: 1990–2010. Br. J. Ophthalmol. 98:5 (2014), 629–638, 10.1136/bjophthalmol-2013-304033.
8. Brown, D.M., et al. Ranibizumab versus Verteporfin for Neovascular age-related macular degeneration. N. Engl. J. Med. 355:14 (2006), 1432–1444.
9. Brown, D.M., et al. Ranibizumab versus Verteporfin photodynamic therapy for Neovascular age-related macular degeneration: two year results of the ANCHOR study. Ophthalmology 116:1 (2009), 57–65.e5, 10.1016/j.ophtha.2008.10.018.
10. Busbee, B.G., et al. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg Ranibizumab in patients with subfoveal neovascular age related macular degeneration. Ophthalmology 120:5 (2013), 1046–1056, 10.1016/j.ophtha.2012.10.014.
11. Campbell, J.P., et al. Impact of availability of anti-vascular endothelial growth factor therapy on visual impairment and Blindness due to Neovascular age-related macular degeneration. Arch. Ophthalmol. 130:6 (2012), 794–795, 10.1001/archophthalmol.2011.2480.
12. Carneiro, A.M., et al. Vascular endothelial growth factor plasma levels before and after treatment of neovascular age-related macular degeneration with bevacizumab or ranibizumab. Acta Ophthalmol. 90:1 (2012), e25–e30, 10.1111/j.1755-3768.2011.02240.x.
13. Castellon, R., et al. Effects of Angiogenic growth factor combinations on retinal endothelial cells. Exp. Eye Res. 74:4 (2002), 523–535.
14. Chakravarthy, U., et al. Year 2 efficacy results of 2 randomized controlled clinical trials of Pegaptanib for Neovascular age-related macular degeneration. Ophthalmology 113:9 (2006), 1508.e1–1508.e25.
15. Chakravarthy, U., Ranibizumab versus Bevacizumab to treat Neovascular Agerelated macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology 119:7 (2012), 1399–1411, 10.1016/j.ophtha.2012.04.015.
16. Chakravarthy, U., Alternative treatments to inhibit VEGF in age-related Choroidal Neovascularisation: 2-year findings of the IVAN randomised controlled trial. Lancet 12:9900 (2013), 1258–1267, 10.1016/S0140-6736(13)61501-9.
17. Chang, T.S., et al. Improved vision-related function after Ranibizumab treatment of Neovascular age-related macular degeneration: results of a randomized clinical trial. Arch. Ophthalmol. 125:11 (2007), 1460–1469.
18. Chen, Y., et al. Selection and analysis of an optimized anti-VEGF antibody: crystal structure of an affinity-matured fab in complex with antigen. J. Mol. Biol. 293:4 (1999), 865–881.
19. Day, S., et al. Medicare costs for Neovascular age-related macular degeneration, 1994–2007. Am. J. Ophthalmol. 152:6 (2011), 1014–1020, 10.1016/j.ajo.2011.05.008.
20. Despreaux, R., et al. Short-term results of switchback from Aflibercept to Ranibizumab in Neovascular age-related macular degeneration in clinical practice. Graefes Arch. Clin. Exp. Ophthalmol., 2015, 2015 (Epub ahead of print).
21. Ferrara, N., et al. The biology of VEGF and its receptors. Nat. Med. 9:6 (2003), 669–676.
22. Ferrara, N., et al. Targeting VEGF-A to treat cancer and age-related macular degeneration. Annu Rev. Med. 58 (2007), 491–504.
23. Frennesson, C., et al. 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. 88:4 (2010), 420–425, 10.1111/j.1755-3768.2009.01576.x.
24. Fung, A.E., et al. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (lucentis) for neovascular age-related macular degeneration. Am. J. Ophthalmol. 143:4 (2007), 566–583.
25. Garcìa-Layana, A., et al. Treatment of exudative age-related macular degeneration: focus on aflibercept. Drugs Aging 32:10 (2015), 797–807, 10.1007/s40266-015-0300-y.
26. Gasperini, J.L., et al. Bevacizumab and ranibizumab tachyphylaxis in the treatment of choroidal neovascularisation. Br. J. Ophthalmol. 96:1 (2012), 14–20, 10.1136/bjo.2011.204685.
27. Gaudreault, J., et al. Preclinical pharmacokinetics of Ranibizumab (rhuFabV2) after a single intravitreal administration. Invest. Ophthalmol. Vis. Sci. 46:2 (2005), 726–733.
28. Gragoudas, E.S., et al. Pegaptanib for Neovascular age-related macular degeneration. N. Engl. J. Med. 351:27 (2004), 2805–2816.
29. Hawkes, N., Avastin is as effective as Lucentis for wet AMD and could save NHS 84 m Pound a year, study shows. BMJ, 344, 2012, e3275, 10.1136/bmj.e3275.
30. Heier, J.S., et al. Intravitreal Aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology 119:12 (2012), 2537–2548, 10.1016/j.ophtha.2012.09.006.
31. Ho, A.C., et al. HARBOR study group. twenty-four-month efficacy and safety of 0.5 mg or 2.0 mg Ranibizumab in patients with Subfoveal Neovascular age-related macular degeneration. Ophthalmology 121:11 (2014), 2181–2192, 10.1016/j.ophtha.2014.05.009.
32. Ho, V.Y., et al. Short-term outcomes of aflibercept for neovascular agerelated macular degeneration in eyes previously treated with other vascular endothelial growth factor inhibitors. Am. J. Ophthalmol. 156:1 (2013), 23–28, 10.1016/j.ajo.2013.02.009.
33. Holz, F.G., et al. Safety and efficacy of a flexible dosing regimen of Ranibizumab in Neovascular age-related macular degeneration: the SUSTAIN study. Ophthalmology 118:4 (2011), 663–671, 10.1016/j.ophtha.2010.12.019.
34. Holz, F.G., et al. LUMINOUS steering committee. Safety of Ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European Neovascular AMD registries within the LUMINOUS programme. Br. J. Ophthalmol. 97:9 (2013), 1161–1167, 10.1136/bjophthalmol-2013-303232.
35. Jansen, R.M., The off-label use of medication: the latest on the Avastin—Lucentis debacle. Med. Law 32:1 (2013), 65–77.
36. Johnson, D., Sharma, S., Ocular and systemic safety of Bevacizumab and Ranibizumab in patients with Neovascular age-related macular degeneration. Curr. Opin. Ophthalmol. 24:3 (2013), 205–212, 10.1097/ICU.0b013e32835f8ec0.
37. Kawasaki, R., et al. The prevalence of age-related macular degeneration in Asians: a systematic review and meta-analysis. Ophthalmology 117:5 (2010), 921–927, 10.1016/j.ophtha.2009.10.007.
38. Kodjikian, L., et al. Ranibizumab versus bevacizumab for neovascular age-related macular degeneration: results from the GEFAL noninferiority randomized trial. Ophthalmology 120:11 (2013), 2300–2309, 10.1016/j.ophtha.2013.06.020.
39. Krzystolik, M.G., et al. Prevention of experimental choroidal neovascularization with intravitreal anti-vascular endothelial growth factor antibody fragment. Arch. Ophthalmol. 120:3 (2002), 338–346.
40. Mantel, I., et al. Conversion to aflibercept therapy versus continuing with ranibizumab therapy for neovascular agerelated macular degeneration dependent on monthly ranibizumab treatment. Retina, 2015, 10.1097/IAE.0000000000000664.
41. Martin, D.F., et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 119:7 (2012), 1388–1398, 10.1016/j.ophtha.2012.03.053.
42. Matsuyama, K., et al. Plasma levels of vascular endothelial growth factor and pigment epithelium-derived factor before and after intravitreal injection of bevacizumab. Br. J. Ophthalmol. 94:9 (2010), 1215–1218, 10.1136/bjo.2008.156810.
43. Moshfeghi, A.A., et al. Pegaptanib sodium for the treatment of Neovascular age-related macular degeneration. Expert Opin. Invest. Drugs 14:5 (2005), 671–682.
44. Papadopoulos, N., et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF trap, Ranibizumab and Bevacizumab. Angiogenesis 15:2 (2012), 171–185, 10.1007/s10456-011-9249-6.
45. Rakic, J.M., et al. Placental growth factor, a member of the VEGF family, contributes to the development of choroidal neovascularization. Invest. Ophthalmol. Vis. Sci. 44:7 (2003), 3186–3193.
46. Regillo, C.D., et al. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 1. Am. J. Ophthalmol. 145:2 (2008), 239–248, 10.1016/j.ajo.2007.10.004.
47. Rein, D.B., et al. Forecasting age-related macular degeneration through the year 2050: the potential impact of new treatments. Arch. Ophthalmol. 127:4 (2009), 533–540, 10.1001/archophthalmol.2009.58.
48. Rofagha, S., et al. Seven-year outcomes in ranibizumab-treated patients in ANCHOR, MARINA, and HORIZON: a multicenter cohort study (SEVEN-UP). ophthalmology., 120(11), 2013, 2292–2299, 10.1016/j.ophtha.2013.03.046.
49. Rosenfeld, P.J., et al. Optical coherence tomography findings after an Intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg. Lasers Imaging 36:4 (2005), 331–335.
50. Rosenfeld, P.J., et al. Ranibizumab for Neovascular age-related macular degeneration. Engl. J. Med. 355 (2006), 1419–1431.
51. Rosenfeld, P.J., et al. Characteristics of patients losing vision after 2 years of monthly dosing in the phase III Ranibizumab clinical trials. Ophthalmology 118:3 (2011), 523–530, 10.1016/j.ophtha.2010.07.011.
52. Santarelli, M., et al. Advances in pharmacotherapy for wet age-related macular degeneration. Expert Opin. Pharm. 16:12 (2015), 1769–1781, 10.1517/14656566.2015.1067679.
53. Schmidt-Erfurth, U., et al. Guidance for the treatment of neovascular age-related macular degeneration. Acta Ophthalmol. Scand. 85:5 (2007), 486–494.
54. Schmidt-Erfurth, U., et al. Efficacy and safety of monthly versus quarterly ranibizumab treatment in neovascular age-related macular degeneration: the EXCITE study. Ophthalmology 118:5 (2011), 831–839, 10.1016/j.ophtha.2010.09.004.
55. Schmidt-Erfurth, U., et al. Guidelines for the management of neovascular age-related macular degeneration by the European society of retina specialists (EURETINA). Br. J. Ophthalmol. 98:9 (2014), 1144–1167, 10.1136/bjophthalmol-2014-305702.
56. Schmidt-Erfurth, U., et al. Intravitreal Aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology 121:1 (2014), 193–201, 10.1016/j.ophtha.2013.08.011.
57. Schmucker, C., et al. A safety review and meta-analyses of Bevacizumab and Ranibizumab: offlabel versus Goldstandard. PLoS One, 7(8), 2012, e42701, 10.1371/journal.pone.0042701.
58. Semeraro, F., et al. Aflibercept in wet AMD: specific role and optimal use. Drug Des. Dev. Ther. 7 (2013), 711–722, 10.2147/DDDT.S40215.
59. Silva, R., et al. The SECURE study: long-term safety of Ranibizumab 0.5 mg in Neovascular age-related macular degeneration. Ophthalmology 120:1 (2013), 130–139, 10.1016/j.ophtha.2012.07.026.
60. Singer, M.A., et al. HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age related macular degeneration. Ophthalmology 119:6 (2012), 1175–1183, 10.1016/j.ophtha.2011.12.016.
61. Singh, R.P., et al. A single-arm, investigator-initiated study of the efficacy, safety and Tolerability of Intravitreal Aflibercept injection in subjects with exudative age-related macular degeneration, previously treated with Ranibizumab or Bevacizumab: 6-month interim analysis. Br. J. Ophthalmol. 98:1 (2014), i22–i27, 10.1136/bjophthalmol-2013-304798.
62. Singh, R.P., et al. A single-arm, investigator-initiated study of the efficacy, safety, and Tolerability of Intravitreal Aflibercept injection in subjects with exudative age-related macular degeneration previously treated with Ranibizumab or Bevacizumab (ASSESS study): 12-month analysis. Clin. Ophthalmol. 9 (2015), 1759–1766, 10.2147/OPTH.S87043.
63. Smith, W., et al. Risk factors for age-related macular degeneration: pooled findings from three continents. Ophthalmology 108 (2001), 697–704.
64. Spilsbury, K., et al. Overexpression of vascular endothelial growth factor (VEGF) in the retinal pigment epithelium leads to the development of choroidal neovascularization. Am. J. Pathol. 157:1 (2000), 135–144.
65. Stewart, M.W., Rosenfeld, P.J., Predicted biological activity of Intravitreal VEGF trap. Br. J. Ophthalmol. 92:5 (2008), 667–668, 10.1136/bjo.2007.134874.
66. Stewart, M.W., What are the half-lives of ranibizumab and aflibercept (VEGF Trap-eye) in human eyes? Calculations with a mathematical model. Eye Rep., 1, 2011, e5.
67. Stewart, M.W., et al. Pharmacokinetic rationale for dosing every 2 weeks versus 4 weeks with intravitreal ranibizumab, bevacizumab, and aflibercept (vascular endothelial growth factor trap-eye). Retina 32:3 (2012), 434–457, 10.1097/IAE.0B013E31822C290F.
68. Thulliez, M., et al. Cardiovascular events and bleeding risk associated with intravitreal antivascular endothelial growth factor monoclonal antibodies: systematic review and meta-analysis. JAMA Ophthalmol. 132:11 (2014), 1317–1326, 10.1001/jamaophthalmol.2014.2333.
69. Tolentino, M.J., et al. Drugs in phase II clinical trials for the treatment of age-related macular degeneration. Expert Opin. Invest. Drugs. 24:2 (2015), 183–199, 10.1517/13543784.2015.961601.
70. van der Reis, M.I., et al. A systematic review of the adverse events of Intravitreal anti-vascular endothelial growth factor injections. Retina 31:8 (2011), 1449–1469, 10.1097/IAE.0b013e3182278ab4.
71. Winnik, S., et al. Systemic VEGF inhibition accelerates experimental atherosclerosis and disrupts endothelial homeostasis—implications for cardiovascular safety. Int. J. Cardiol. 168:3 (2013), 2453–2461, 10.1016/j.ijcard.2013.03.010.
72. Wykoff, C.C., et al. TREX-AMD study group*. Prospective Trial of treat-and-extend versus monthly dosing for neovascular age-related macular degeneration: TREX-AMD 1-year results. Ophthalmology, 2015, 18, 10.1016/j.ophtha.2015.08.009 pii: S0161-6420(15)00786-1.
73. Yonekawa, Y., et al. Conversion to Aflibercept for chronic refractory or recurrent Neovascular age-related macular degeneration. Am. J. Ophthalmol. 156:1 (2013), 29–35, 10.1016/j.ajo.2013.03.030.
74. Zayit-Soudry, S., et al. Safety evaluation of repeated Intravitreal injections of Bevacizumab and Ranibizumab in rabbit eyes. Retina 30:4 (2010), 671–681, 10.1097/IAE.0b013e3181c0858c.
75. Zehetner, C., et al. 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 patientswith diabetic macular oedema. Br. J. Ophthalmol. 97:4 (2013), 454–459, 10.1136/bjophthalmol-2012-302451.