Anti-Vascular Endothelial Growth Factor Pharmacotherapy for Age-Related Macular Degeneration. A Report by the American Academy of Ophthalmology

Ophthalmology

Volumn 115, Issue 10, 2008, Pages 1837-1846

  Ip, Michael S ^a   Scott, Ingrid U ^a   Brown, Gary C ^a   Brown, Melissa M ^a   Ho, Allen C ^a   Huang, Suber S ^a   Recchia, Franco M ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; PEGAPTANIB; RANIBIZUMAB; VASCULOTROPIN ANTIBODY; VERTEPORFIN;

ARTICLE; BACTERIAL INFECTION; BLEEDING; BLOOD PRESSURE; CLINICAL TRIAL; COCHRANE LIBRARY; COLORECTAL CANCER; DIGESTIVE SYSTEM PERFORATION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; ENDOPHTHALMITIS; HEART INFARCTION; HUMAN; HYPERTENSIVE CRISIS; INFORMATION RETRIEVAL; NEPHROTIC SYNDROME; PHOTODYNAMIC THERAPY; PRIORITY JOURNAL; RETINA DETACHMENT; RETINA MACULA AGE RELATED DEGENERATION; SIDE EFFECT; STROKE; SYSTEMATIC REVIEW; THROMBOEMBOLISM; UNSPECIFIED SIDE EFFECT; UVEITIS; VITREOUS HEMORRHAGE;

ACADEMIES AND INSTITUTES; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; APTAMERS, NUCLEOTIDE; CHOROIDAL NEOVASCULARIZATION; DRUG THERAPY; HUMANS; MACULAR DEGENERATION; TECHNOLOGY ASSESSMENT, BIOMEDICAL; TREATMENT OUTCOME; UNITED STATES; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 52949129894     PISSN: 01616420     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ophtha.2008.08.012     Document Type: Article

References (89)

1. Kahn H.A., Leibowitz H.M., Ganley J.P., et al. The Framingham Eye Study. I. Outline and major prevalence findings. Am J Epidemiol 106 (1977) 17-32
2. Klein B.E., and Klein R. Cataracts and macular degeneration in older Americans. Arch Ophthalmol 100 (1982) 571-573
3. Klein R., Klein B.E., and Linton K.L. Prevalence of age-related maculopathy: the Beaver Dam Eye Study. Ophthalmology 99 (1992) 933-943
4. Sommer A., Tielsch J.M., Katz J., et al. Racial differences in the cause-specific prevalence of blindness in east Baltimore. N Engl J Med 325 (1991) 1412-1417
5. Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol 122 (2004) 564-572
6. Ferris III F.L., Fine S.L., and Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol 102 (1984) 1640-1642
7. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Macugen (pegaptanib sodium injection). NDA 21-756/S006. http://www.fda.gov/cder/foi/label/2006/021756s006,s0071bl.pdf Accessed July 3, 2008
8. Bhisitkul R.B. Vascular endothelial growth factor biology: clinical implications for ocular treatments. Br J Ophthalmol 90 (2006) 1542-1547
9. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Genentech, Inc. Avastin (Bevacizumab). Draft labeling text. BL125085/145 Amendment. Revised February 2008:13. http://www.fda.gov/cder/foi/label/2008/125085s1451bl.pdf Accessed July 7, 2008
10. Michels S., Rosenfeld P.J., Puliafito C.A., et al. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: twelve-week results of an uncontrolled open-label clinical study. Ophthalmology 112 (2005) 1035-1047
11. Moshfeghi A.A., Rosenfeld P.J., Puliafito C.A., et al. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: twenty-four-week results of an uncontrolled open-label clinical study. Ophthalmology 113 (2006) 2002-2011
12. Rosenfeld P.J., Moshfeghi A.A., and Puliafito C.A. Optical coherence tomography findings after an intravitreal injection of bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging 36 (2005) 331-335
13. Abraham-Marin M.L., Cortes-Luna C.F., Alvarez-Rivera G., et al. Intravitreal bevacizumab therapy for neovascular age-related macular degeneration: a pilot study. Graefes Arch Clin Exp Ophthalmol 245 (2007) 651-655
14. Avery R.L., Pieramici D.J., Rabena M.D., et al. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmology 113 (2006) 363-372
15. Spaide R.F., Laud K., Fine H.F., et al. Intravitreal bevacizumab treatment of choroidal neovascularization secondary to age-related macular degeneration. Retina 26 (2006) 383-390
16. Yoganathan P., Deramo V.A., Lai J.C., et al. Visual improvement following intravitreal bevacizumab (Avastin) in exudative age-related macular degeneration. Retina 26 (2006) 994-998
17. Bashshur Z.F., Bazarbachi A., Schakal A., et al. Intravitreal bevacizumab for the management of choroidal neovascularization in age-related macular degeneration. Am J Ophthalmol 142 (2006) 1-9
18. Rich R.M., Rosenfeld P.J., Puliafito C.A., et al. Short-term safety and efficacy of intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Retina 26 (2006) 495-511
19. Aggio F.B., Farah M.E., Silva W.C., and Melo G.B. Intravitreal bevacizumab for exudative age-related macular degeneration after multiple treatments. Graefes Arch Clin Exp Ophthalmol 245 (2007) 215-220
20. Hughes M.S., and Sang D.N. Safety and efficacy of intravitreal bevacizumab followed by pegaptanib maintenance as a treatment regimen for age-related macular degeneration. Ophthalmic Surg Lasers Imaging 37 (2006) 446-454
21. Costa R.A., Jorge R., Calucci D., et al. Intravitreal bevacizumab (Avastin) in combination with verteporfin photodynamic therapy for choroidal neovascularization associated with age-related macular degeneration (IBeVe Study). Graefes Arch Clin Exp Ophthalmol 245 (2007) 1273-1280
22. Augustin A.J., Puls S., and Offermann I. Triple therapy for choroidal neovascularization due to age-related macular degeneration: verteporfin PDT, bevacizumab, and dexamethasone. Retina 27 (2007) 133-140
23. Lazic R., and Gabric N. Intravitreally administered bevacizumab (Avastin) in minimally classic and occult choroidal neovascularization secondary to age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 245 (2007) 68-73
24. Giansanti F., Virgili G., Bini A., et al. Intravitreal bevacizumab therapy for choroidal neovascularization secondary to age-related macular degeneration: 6-month results of an open-label uncontrolled clinical study. Eur J Ophthalmol 17 (2007) 230-237
25. Chen C.Y., Wong T.Y., and Heriot W.J. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration: a short-term study. Am J Ophthalmol 143 (2007) 510-512
26. Emerson M.V., Lauer A.K., Flaxel C.J., et al. Intravitreal bevacizumab (Avastin) treatment of neovascular age-related macular degeneration. Retina 27 (2007) 439-444
27. Goff M.J., Johnson R.N., McDonald H.R., et al. Intravitreal bevacizumab for previously treated choroidal neovascularization from age-related macular degeneration. Retina 27 (2007) 432-438
28. Mones J.M., Lopez M.A., Prieto J.A., and Rodriguez J.P. Extrafoveal choroidal neovascularization secondary to wet age-related macular degeneration treated with intravitreal bevacizumab. Ophthalmic Surg Lasers Imaging 38 (2007) 226-228
29. Lazic R., and Gabric N. Verteporfin therapy and intravitreal bevacizumab combined and alone in choroidal neovascularization due to age-related macular degeneration. Ophthalmology 114 (2007) 1179-1185
30. Falkenstein I.A., Cheng L., Morrison V.L., et al. Standardized visual acuity results associated with primary versus secondary bevacizumab (Avastin) treatment for choroidal neovascularization in age-related macular degeneration. Retina 27 (2007) 701-706
31. Jonas J.B., Libondi T., Ihloff A.K., et al. Visual acuity change after intravitreal bevacizumab for exudative age-related macular degeneration in relation to subfoveal membrane type. Acta Ophthalmol Scand 85 (2007) 563-565
32. Pedersen R., Soliman W., Lund-Andersen H., and Larsen M. Treatment of choroidal neovascularization using intravitreal bevacizumab. Acta Ophthalmol Scand 85 (2007) 526-533
33. Aisenbrey S., Ziemssen F., Volker M., et al. Intravitreal bevacizumab (Avastin) for occult choroidal neovascularization in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 245 (2007) 941-948
34. Bashshur Z.F., Schakal A., Hamam R.N., et al. Intravitreal bevacizumab vs verteporfin photodynamic therapy for neovascular age-related macular degeneration. Arch Ophthalmol 125 (2007) 1357-1361
35. Costa R.A., Jorge R., Calucci D., et al. Intravitreal bevacizumab for choroidal neovascularization caused by AMD (IBeNA Study): results of a phase 1 dose-escalation study. Invest Ophthalmol Vis Sci 47 (2006) 4569-4578
36. Chapman J.A., and Beckey C. Pegaptanib: a novel approach to ocular neovascularization. Ann Pharmacother 40 (2006) 1322-1326
37. Web J.A. Genentech decision expands access to bevacizumab (2008), Ophthalmol Times January 15
38. Boyer D.S., Antoszyk A.N., Awh C.C., et al., MARINA Study Group. Subgroup analysis of the MARINA study of ranibizumab in neovascular age-related macular degeneration. Ophthalmology 114 (2007) 246-252
39. Brown D.M., Kaiser P.K., Michels M., et al., ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 355 (2006) 1432-1444
40. Gragoudas E.S., Adamis A.P., Cunningham Jr. E.T., et al., VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med 351 (2004) 2805-2816
41. Heier J.S., Antoszyk A.N., Pavan P.R., et al. Ranibizumab for treatment of neovascular age-related macular degeneration: a phase I/II multicenter, controlled, multidose study. Ophthalmology 113 (2006) 633-642
42. Heier J.S., Boyer D.S., Ciulla T.A., et al., FOCUS Study Group. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration: year 1 results of the FOCUS Study. Arch Ophthalmol 124 (2006) 1532-1542
43. Rosenfeld P.J., Brown D.M., Heier J.S., et al., MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 355 (2006) 1419-1431
44. Kaiser P.K., Blodi B.A., Shapiro H., Acharya N.R., and MARINA Study Group. Angiographic and optical coherence tomographic results of the MARINA study of ranibizumab in neovascular age-related macular degeneration. Ophthalmology 114 (2007) 1868-1875
45. Kaiser P.K., Brown D.M., Zhang K., et al. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol 144 (2007) 850-857
46. VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N.) Clinical Trial Group. Year 2 efficacy results of 2 randomized controlled clinical trials of pegaptanib for neovascular age-related macular degeneration. Ophthalmology 113 (2006) 1508-1521
47. VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N.) Clinical Trial Group. Pegaptanib sodium for neovascular age-related macular degeneration: two-year safety results of the two prospective, multicenter, controlled clinical trials. Ophthalmology 113 (2006) 992-1001
48. Macugen AMD Study Group. Pegaptanib 1-year systemic safety results from a safety-pharmacokinetic trial in patients with neovascular age-related macular degeneration. Ophthalmology 114 (2007) 1702-1712
49. Rosenfeld P.J., Heier J.S., Hantsbarger G., and Shams N. Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration. Ophthalmology 113 (2006) 623-632
50. Rosenfeld P.J., Schwartz S.D., Blumenkranz M.S., et al. Maximum tolerated dose of a humanized anti-vascular endothelial growth factor antibody fragment for treating neovascular age-related macular degeneration. Ophthalmology 112 (2005) 1048-1053
51. Nguyen Q.D., Shah S.M., Hafiz G., et al., CLEAR-AMD 1 Study Group. A phase I trial of an IV-administered vascular endothelial growth factor trap for treatment in patients with choroidal neovascularization due to age-related macular degeneration. Ophthalmology 113 (2006) 1522-1532
52. Eyetech Study Group. Preclinical and phase 1A clinical evaluation of an anti-VEGF pegylated aptamer (EYE001) for the treatment of exudative age-related macular degeneration. Retina 22 (2002) 143-152
53. Aggio F.B., Farah M.E., de Melo G.B., et al. Acute endophthalmitis following intravitreal bevacizumab (Avastin) injection. Eye 21 (2007) 408-409
54. Bakri S.J., and Kitzmann A.S. Retinal pigment epithelial tear after intravitreal ranibizumab. Am J Ophthalmol 143 (2007) 505-507
55. Bom Aggio F., Eid Farah M., and Melo G.B. Intravitreal bevacizumab for occult choroidal neovascularization with pigment epithelium detachment in age-related macular degeneration. [letter]. Acta Ophthalmol Scand 84 (2006) 713-714
56. Fung A.E., Lalwani G.A., Rosenfeld P.J., et al. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol 143 (2007) 566-583
57. Fung A.E., Rosenfeld P.J., and Reichel E. The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Br J Ophthalmol 90 (2006) 1344-1349
58. Lee G.K., Lai T.Y., Chan W.M., and Lam D.S. Retinal pigment epithelial tear following intravitreal ranibizumab injections for neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 245 (2007) 1225-1227
59. Maturi R.K., Bleau L.A., and Wilson D.L. Electrophysiologic findings after intravitreal bevacizumab (Avastin) treatment. Retina 26 (2006) 270-274
60. Meyer C.H., Mennel S., Horle S., and Schmidt J.C. Visual hallucinations after intravitreal injection of bevacizumab in vascular age-related macular degeneration. Am J Ophthalmol 143 (2007) 169-170
61. Rosenfeld P.J., Fung A.E., and Puliafito C.A. Optical coherence tomography findings after an intravitreal injection of bevacizumab (Avastin) for macular edema from central retinal vein occlusion. Ophthalmic Surg Lasers Imaging 36 (2005) 336-339
62. Shah C.P., Hsu J., Garg S.J., et al. Retinal pigment epithelial tear after intravitreal bevacizumab injection. Am J Ophthalmol 142 (2006) 1070-1072
63. Spandau U.H., and Jonas J.B. Retinal pigment epithelium tear after intravitreal bevacizumab for exudative age-related macular degeneration. Am J Ophthalmol 142 (2006) 1068-1070
64. Steffensmeier A.C., Azar A.E., Fuller J.J., et al. Vitreous injections of pegaptanib sodium triggering allergic reactions. Am J Ophthalmol 143 (2007) 512-513
65. Chan C.K., Meyer C.H., Gross J.G., et al. Retinal pigment epithelial tears after intravitreal bevacizumab injection for neovascular age-related macular degeneration. Retina 27 (2007) 541-551
66. Chang L.K., and Sarraf D. Tears of the retinal pigment epithelium: an old problem in a new era. Retina 27 (2007) 523-534
67. Chen E., Kaiser R.S., and Vander J.F. Intravitreal bevacizumab for refractory pigment epithelial detachment with occult choroidal neovascularization in age-related macular degeneration. Retina 27 (2007) 445-450
68. Kiss C., Michels S., Prager F., et al. Evaluation of anterior chamber inflammatory activity in eyes treated with intravitreal bevacizumab. Retina 26 (2006) 877-881
69. Quiram P.A., Hassan T.S., and Williams G.A. Treatment of naive lesions in neovascular age-related macular degeneration with pegaptanib. Retina 27 (2007) 851-856
70. Ronan S.M., Yoganathan P., Chien F.Y., et al. Retinal pigment epithelium tears after intravitreal injection of bevacizumab (Avastin) for neovascular age-related macular degeneration. Retina 27 (2007) 535-540
71. Jonas J.B., Spandau U.H., Rensch F., et al. Infectious and noninfectious endophthalmitis after intravitreal bevacizumab. J Ocul Pharmacol Ther 23 (2007) 240-242
72. Hannan S.R., Madhusudhana K.C., Lotery A.J., and Newsom R.S. Retinal pigment epithelial tear following intravitreal bevacizumab for choroidal neovascular membrane due to age-related macular degeneration. [letter]. Br J Ophthalmol 91 (2007) 977-978
73. Wu L., Martinez-Castellanos M.A., Quiroz-Mercado H., et al., Pan American Collaborative Retina Group (PACORES). Twelve-month safety of intravitreal injections of bevacizumab (Avastin): results of the Pan-American Collaborative Retina Study Group (PACORES). Graefes Arch Clin Exp Ophthalmol 246 (2008) 81-87
74. Ferrara N., Damico L., Shams N., et al. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina 26 (2006) 859-870
75. Rosenfeld P.J., Rich R.M., and Lalwani G.A. Ranibizumab: phase III clinical trial results. Ophthalmol Clin North Am 19 (2006) 361-372
76. Manzano R.P., Peyman G.A., Khan P., and Kivilcim M. Testing intravitreal toxicity of bevacizumab (Avastin). Retina 26 (2006) 257-261
77. Shahar J., Avery R.L., Heilweil G., et al. Electrophysiologic and retinal penetration studies following intravitreal injection of bevacizumab (Avastin). Retina 26 (2006) 262-269
78. Bakri S.J., Snyder M.R., Reid J.M., et al. Pharmacokinetics of intravitreal ranibizumab (Lucentis). Ophthalmology 114 (2007) 2179-2182
79. Raftery J., Clegg A., Jones J., et al. Ranibizumab (Lucentis) versus bevacizumab (Avastin): modelling cost effectiveness. Br J Ophthalmol 91 (2007) 1244-1246
80. Brown M.M., Brown G.C., Brown H.C., and Peet J. A value-based medicine analysis of ranibizumab for the treatment of subfoveal neovascular macular degeneration. Ophthalmology 115 (2008) 1039-1045
81. Ziemssen F., Warga M., Neuhann I.M., et al. Does intravitreal injection of bevacizumab have an effect on the blood-aqueous barrier function [letter]?. Br J Ophthalmol 90 (2006) 922
82. Gillies M.C., and Wong T.Y. Ranibizumab for neovascular age-related macular degeneration. [letter]. N Engl J Med 356 (2007) 748-749
83. Rosenfeld P.J., Brown D.M., Schneider S., Liew G., Mitchell P., Gillies M.C., and Wong T.Y. Ranibizumab for neovascular age-related macular degeneration. [letter]. N Engl J Med 356 (2007) 749-750
84. Tan C.S., Sanjay S., and Eong K.G. Charles Bonnet syndrome (visual hallucinations) after intravitreal Avastin injection for age-related macular degeneration. [letter]. Am J Ophthalmol 144 (2007) 330
85. Meyer C.H., Mennel S., Rodrigues E.B., Schmidt J.C., Tan C.S., Sanjay S., and Eong K.G. Charles Bonnet syndrome (visual hallucinations) after intravitreal Avastin injection for age-related macular degeneration. [letter]. Am J Ophthalmol 144 (2007) 330-331
86. American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern. Age-Related Macular Degeneration (2008), American Academy of Ophthalmology, San Francisco, CA 9-11. http://one.aao.org/CE/PracticeGuidelines/PPP.aspx Accessed July 7, 2008
87. Regillo C.D., Brown D.M., Abraham P., et al., PIER Study Group. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol 145 (2008) 239-248
88. National Eye Institute. Comparison of age-related macular degeneration treatments trials: Lucentis-Avastin trial (CATT). http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=137 Accessed July 3, 2008
89. Lucas R.S., McKee H.D., and Lee L.R. Intravitreal bevacizumab. [letter]. Ophthalmology 114 (2007) 400