Pharmacotherapy for the treatment of choroidal neovascularization due to age-related macular degeneration

Annual Review of Pharmacology and Toxicology

Volumn 48, Issue , 2008, Pages 61-78

  Novack, Gary D ^a  

^a PHARMALOGIC DEVELOPMENT INC   (United States)

Author keywords

Bevacizumab; Choroidal neovascularization; Pegaptanib; Ranibizumab; Verteporfin

Indexed keywords

BEVACIZUMAB; FLUOROURACIL; PEGAPTANIB; PLACEBO; RANIBIZUMAB; VASCULOTROPIN A; VERTEPORFIN; APTAMER; MONOCLONAL ANTIBODY; PORPHYRIN;

CLINICAL TRIAL; DRUG COST; DRUG SUBSTITUTION; HUMAN; LASER COAGULATION; LOW LEVEL LASER THERAPY; PATHOGENESIS; PHOTODYNAMIC THERAPY; PREVALENCE; PRIORITY JOURNAL; RETINA MACULA AGE RELATED DEGENERATION; REVIEW; SUBRETINAL NEOVASCULARIZATION; RETINA MACULA DEGENERATION;

ANTIBODIES, MONOCLONAL; APTAMERS, NUCLEOTIDE; CHOROIDAL NEOVASCULARIZATION; HUMANS; LASER COAGULATION; MACULAR DEGENERATION; PORPHYRINS; PREVALENCE;

EID: 41149100730     PISSN: 03621642     EISSN: None     Source Type: Book Series    
DOI: 10.1146/annurev.pharmtox.48.060607.174028     Document Type: Review

References (83)

1. Amin HI, McDonald HR, Johnson RN, Ai E, Schatz H. 2002. Acquired macular disease. In Duane's Clinical Ophthalmology, Vol. 3, Chpt. 23, ed. W Tasman, EA Jaeger. Philadelphia: J.B. Lippincott Co.
2. Sommer A, Tielsch JM, Katz J, Quigley HA, Gottsch JD, et al. 1991. Racial differences in the cause-specific prevalence of blindness in east Baltimore. N. Engl. J. Med. 325:1412-17
3. Klein R, Wang Q, Klein BE, Moss SE, Meuer SM. 1995. The relationship of age-related maculopathy, cataract, and glaucoma to visual acuity. Invest Ophthalmol. Vis. Sci. 36:182-91
4. Klaver CC, Wolfs RC, Vingerling JR, Hofman A, de Jong PT. 1998. Age-specific prevalence and causes of blindness and visual impairment in an older population: the Rotterdam Study. Arch. Ophthalmol. 116:653-58
5. Wang JJ, Foran S, Mitchell P. 2000. Age-specific prevalence and causes of bilateral and unilateral visual impairment in older Australians: the Blue Mountains Eye Study. Clin. Exp. Ophthalmol. 28:268-73
6. Munoz B, West SK, Rubin GS, Schein OD, Quigley HA, et al. 2000. Causes of hlindness and visual impairment in a population of older Americans: the Salisbury Eye Evaluation Study. Arch. Ophthalmol. 118:819-25
7. Weih LM, VanNewkirk MR, McCarty CA, Taylor HR. 2000. Age-specific causes of bilateral visual impairment. Arch. Ophthalmol. 118:264-69
8. Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, et al. 2004. Prevalence of age-related macular degeneration in the United States. Arch. Ophthalmol. 122:564-72
9. Macular Photocoagulation Study Group. 1991. Argon laser photocoagulation for neovascular maculopathy. Five-year results from randomized clinical trials. Arch. Ophthalmol. 109:1109-14
10. Macular Photocoagulation Study Group. 1994. Laser photocoagulation for juxtafoveal choroidal neovascularization. Five-year results from randomized clinical trials. Arch. Ophthalmol. 112:500-9
11. Macular Photocoagulation Study Group. 1991. Laser photocoagulation of subfoveal neovascular lesions in age-related macular degeneration. Results of a randomized clinical trial. Arch. Ophthalmol. 109:1220-31
12. Macular Photocoagulation Study Group. 1993. Laser photocoagulation of subfoveal neovascular lesions of age-related macular degeneration. Updated findings from two clinical trials. Arch. Ophthalmol. 111:1200-9
13. Macular Photocoagulation Study Group. 1994. Visual outcome after laser photocoagulation for subfoveal choroidal neovascularization secondary to age-related macular degeneration. The influence of initial lesion size and initial visual acuity. Arch. Ophthalmol. 112:480-88
14. Young LH, Howard MA, Hu LK, Kim RY, Gragoudas ES. 1996. Photodynamic therapy of pigmented choroidal melanomas using a liposomal preparation of benzoporphyrin derivative. Arch. Ophthalmol. 114:186-92
15. Schmidt-Erfurth U, Hasan T, Schomacker K, Flotte T, Birngruber R. 1995. In vivo uptake of liposomal benzoporphyrin derivative and photothrombosis in experimental corneal neovascularization. Lasers Surg. Med. 17:178-88
16. Schmidt-Erfurth U, Hasan T, Flotte T, Gragoudas E, Birngruber R. 1994. Photodynamic therapy of experimental, intraocular tumors with benzoporphyrin-lipoprotein. Ophthalmologe 91:348-56
17. Allison BA, Waterfield E, Richter AM, Levy JG. 1991. The effects of plasma lipoproteins on in vitro tumor cell killing and in vivo tumor photosensitization with benzoporphyrin derivative. Photochem. Photobiol. 54:709-15
18. Schmidt-Erfurth U, Hasan T, Gragoudas E, Michaud N, Flotte TJ, Birngruber R. 1994. Vascular targeting in photodynamic occlusion of subretinal vessels. Ophthalmology 101:1953-61
19. Miller JW, Walsh AW, Kramer M, Hasan T, Michaud N, et al. 1995. Photodynamic therapy of experimental choroidal neovascularization using lipoprotein-delivered benzoporphyrin. Arch. Ophthalmol. 113:810-18
20. Kramer M, Miller JW, Michaud N, Moulton RS, Hasan T, et al. 1996. Liposomal benzoporphyrin derivative verteporfin photodynamic therapy. Selective treatment of choroidal neovascularization in monkeys. Ophthalmology 103:427-38
21. Husain D, Miller JW, Michaud N, Connolly E, Flotte TJ, Gragoudas ES. 1996. Intravenous infusion of liposomal benzoporphyrin derivative for photodynamic therapy of experimental choroidal neovascularization. Arch. Ophthalmol. 114:978-85
22. Weishaupt KR, Gomer CJ, Dougherty TJ. 1976. Identification of singlet oxygen as the cytotoxic agent in photoinactivation of a murine tumor. Cancer Res. 36:2326-29
23. Castellani A, Pace GP, Concioloi M. 1963. Photodynamic effect of haematoporphyrin on blood microcirculation. J. Pathol. Bacteriol. 86:99-102
24. Miller JW, Schmidt-Erfurth U, Sickenberg M, Pournaras CJ, Laqua H, et al. 1999. Photodynamic therapy with verteporfin for choroidal neovascularization caused by age-related macular degeneration: results of a single treatment in a Phase 1 and 2 study. Arch. Ophthalmol. 117:1161-73
25. Schmidt-Erfurth U, Miller JW, Sickenberg M, Laqua H, Barbazetto I, et al. 1999. Photodynamic therapy with verteporfin for choroidal neovascularization caused by age-related macular degeneration: results of retreatments in a Phase 1 and 2 study. Arch. Ophthalmol. 117:1177-87
26. Sickenberg M, Schmidt-Erfurth U, Miller JW, Pournaras CJ, Zografos L, et al. 2000. A preliminary study of photodynamic therapy using verteporfin for choroidal neovascularization in pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, and idiopathic causes. Arch. Ophthalmol. 118:327-36
27. Early Treatment Diabetic Retinopathy Study Research Group. 1985. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 1. Arch. Ophthalmol. 103:1796-806
28. Ferris FL III, Kassoff A, Bresnick GH, Bailey I. 1982. New visual acuity charts for clinical research. Am. J. Ophthalmol. 94:91-96
29. Treatment of Age-related Macular Degeneration With Photodynamic Therapy (TAP) Study Group. 1999. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: one-year results of 2 randomized clinical trials - TAP Report 1. Arch. Ophthalmol. 117:1329-45
30. Bressler NM. 2001. 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. 119:198-207
31. Verteporfin in Photodynamic Therapy Report 2. 2001. 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. Am. J. Ophthalmol. 131:541-60
32. Miller JW, Adamis AP, Shima DT, D'Amore PA, Moulton RS, et al. 1994. Vascular endothelial growth factor/vascular permeability factor is temporally and spatially correlated with ocular angiogenesis in a primate model. Am. J. Pathol. 145:574-84
33. Shams N, Ianchulev T. 2006. Role of vascular endothelial growth factor in ocular angiogenesis. Ophthalmol. Clin. North Am. 19:335-44
34. Shima DT, Adamis AP, Ferrara N, Yeo KT, Yeo TK, et al. 1995. Hypoxic induction of endothelial cell growth factors in retinal cells: identification and characterization of vascular endothelial growth factor (VEGF) as the mitogen. Mol. Med. 1:182-93
35. Aiello LP, Northrup JM, Keyt BA, Takagi H, Iwamoto MA. 1995. Hypoxic regulation of vascular endothelial growth factor in retinal cells. Arch. Ophthalmol. 113:1538-44
36. Adamis AP, Miller JW, Bernal MT, D'Amico DJ, Folkman J, et al. 1994. Increased vascular endothelial growth factor levels in the vitreous of eyes with proliferative diabetic retinopathy. Am. J. Ophthalmol. 118:445-50
37. Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, et al. 1994. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N. Engl. J. Med. 331:1480-87
38. Malecaze F, Clamens S, Simorre-Pinatel V, Mathis A, Chollet P, et al. 1994. Detection of vascular endothelial growth factor messenger RNA and vascular endothelial growth factor-like activity in proliferative diabetic retinopathy. Arch. Ophthalmol. 112:1476-82
39. Adamis AP, Shima DT, Tolentino MJ, Gragoudas ES, Ferrara N, et al. 1996. Inhibition of vascular endothelial growth factor prevents retinal ischemia-associated iris neovascularization in a nonhuman primate. Arch. Ophthalmol. 114:66-71
40. The EyeTech Study Group. 2002. Preclinical and Phase 1A clinical evaluation of an anti-VEGF pegylated aptamer (EYE001) for the treatment of exudative age-related macular degeneration. Retina 22:143-52
41. The EyeTech Study Group. 2003. Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: Phase II study results. Ophthalmology 110:979
42. Cunningham ET Jr, da Silva L, Harrison EM, Modi MW, O'Shaughnessy D, Guyer DR. 2004. Accelerated drug development through combined Phase 2/3 clinical trial design. Arch. Ophthalmol. 122:1043-44
43. Gragoudas ES, Adamis AP, Cunningham ET Jr, Feinsod M, Guyer DR, VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. 2004. Pegaptanib for neovascular age-related macular degeneration. N. Engl. J. Med. 351:2805-16
44. Hariprasad SM, Shah GK, Blinder KJ. 2006. Short-term intraocular pressure trends following intravitreal pegaptanib (Macugen) injection. Am. J. Ophthalmol. 141:200-1
45. Polo V, Larrosa JM, Pinilla I, Gonzalvo F, Ferreras A, Honrubia FM. 2002. Glaucomatous damage patterns by short-wavelength automated perimetry (SWAP) in glaucoma suspects. Eur. J. Ophthalmol. 12:49-54
46. Heier JS, Antoszyk AN, Pavan PR, Leff SR, Rosenfeld PJ, et al. 2006. Ranibizumab for treatment of neovascular age-related macular degeneration: a Phase I/II multicenter, controlled, multidose study. Ophthalmology 113:633-42
47. Rosenfeld PJ, Schwartz SD, Blumenkranz MS, Miller JW, Haller JA, et al. 2005. Maximum tolerated dose of a humanized antivascular endothelial growth factor antibody fragment for treating neovascular age-related macular degeneration. Ophthalmology 112:1048-53
48. Rosenfeld PJ, Heier JS, Hantsbarger G, Shams N. 2006. Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration. Ophthalmology 113:632
49. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, et al. 2006. Ranibizumab for neovascular age-related macular degeneration. N. Engl. J. Med. 355:1419-31
50. Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, et al. 2006. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N. Engl. J. Med. 355:1432-44
51. Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, et al. 2007. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am. J. Ophthalmol. 143:566-83
52. Spaide R. 2007. Ranibizumab according to need: a treatment for age-related macular degeneration. Am. J. Ophthalmol. 143:679-80
53. Michels S, Rosenfeld PJ, Puliafito CA, Marcus EN, Venkatraman AS. 2005. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: twelve-week results of an uncontrolled open-label clinical study. Ophthalmology 112:1035-47
54. Moshfeghi AA, Rosenfeld PJ, Puliafito CA, Michels S, Marcus EN, et al. 2006. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: twenty-four-week results of an uncontrolled open-label clinical study. Ophthalmology 113:2002-12
55. Avery RL, Pieramici DJ, Rabena MD, Castellarin AA, Nasir MA, Giust MJ. 2006. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmology 113:363-72
56. Avery RL. 2006. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina 26:352-54
57. Avery RL, Pearlman J, Pieramici DJ, Rabena MD, Castellarin AA, et al. 2006. Intravitreal bevacizumab (Avastin) in the treatment of proliferative diabetic retinopathy. Ophthalmology 113:1695
58. Bashshur ZF, Bazarbachi A, Schakal A, Haddad ZA, El Haibi CP, Noureddin BN. 2006. Intravitreal bevacizumab for the management of choroidal neovascularization in age-related macular degeneration. Am. J. Ophthalmol. 142:1-9
59. Costa RA, Jorge R, Calucci D, Cardillo JA, Melo LAS Jr, Scott IU. 2006. Intravitreal bevacizumab for choroidal neovascularization caused by AMD (IBeNA Study): results of a Phase 1 dose-escalation study. Invest Ophthalmol. Vis. Sci. 47:4569-78
60. Fung AE, Rosenfeld PJ, Reichel E. 2006. The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Br. J. Ophthalmol. 90:1344-49
61. Rosenfeld PJ. 2006. Intravitreal avastin: the low cost alternative to lucentis? Am. J. Ophthalmol. 142:141-43
62. Gillies MC. 2006. What we don't know about avastin might hurt us. Arch. Ophthalmol. 124:1478-79
63. Kaufman B, Novack GD. 2003. Compliance issues in manufacturing of drugs. Ocul. Surf. 1:80-85
64. Novack GD. 2006. Pipeline: risks and benefits. Ocul. Surf. 4:58-60
65. Novack GD. 2007. Pharmacotherapy: How much drug is there? Ocul. Surf. 5:58-61
66. Jampol LM. 2007. Bevacizumab vs ranibizumab treatment for age-related macular degeneration: A head-to-head comparison is needed. Arch. Ophthalmol. 125:557-8
67. Kaiser PK, Goldberg MF, Davis AA. 2007. Posterior juxtascleral depot administration of anecortave acetate. Survey Ophthalmol. 1:S62-69
68. D'Amico DJ, Goldberg MF, Hudson H, Jerdan JA, Krueger S, et al. 2003. Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD): interim (month 6) analysis of clinical efficacy and safety. Retina 23:14-23
69. Slakter JS. 2003. Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes. Ophthalmology 110:2372-83
70. Slakter JS, Bochow TW, D'Amico DJ, Marks B, Jerdan J, et al. 2006. Anecortave acetate (15 milligrams) versus photodynamic therapy for treatment of subfoveal neovascularization in age-related macular degeneration. Ophthalmology 113:3-13
71. Klais CM, Eandi CM, Ober MD, Sorenson JA, Sadeghi SN, et al. 2006. Anecortave acetate treatment for retinal angiomatous proliferation: a pilot study. Retina 26:773-79
72. Eandi CM, Ober MD, Freund KB, Klais CM, Slakter JS, et al. 2006. Anecortave acetate for the treatment of idiopathic perifoveal telangiectasia: a pilot study. Retina 26:780-85
73. Kuppermann BD, Blumenkranz MS, Haller JA, Williams GA, Weinberg DV, et al. 2007. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch. Ophthalmol. 125:309-17
74. Blumenkranz MS, Woodburn KW, Qing F, Verdooner S, Kessel D, Miller R. 2000. Lutetium texaphyrin (Lu-Tex): a potential new agent for ocular fundus angiography and photodynamic therapy. Am. J. Ophthalmol. 129:353-62
75. Campochiaro PA, Dong NQ, Mahmood SS, Klein ML, Holz E, et al. 2006. Adenoviral vector-delivered pigment epithelium-derived factor for neovascular age-related macular degeneration: results of a Phase I clinical trial. Hum. Gene Ther. 17(2):167-76
76. Lima e Silva R, Kachi S, Akiyama H, Shen J, Hatara MC, et al. 2006. Transscleral delivery of polyamine analogs for ocular neovascularization. Exp. Eye Res. 83:1260-67
77. Lima e Silva R, Saishin Y, Saishin Y, Akiyama H, Kachi S, et al. 2005. Suppression and regression of choroidal neovascularization by polyamine analogues. Invest Ophthalmol. Vis. Sci. 46:3323-30
78. Brafman A, Mett I, Shafir M, Gottlieb H, Damari G, et al. 2004. Inhibition of oxygen-induced retinopathy in RTP801-deficient mice. Invest Ophthalmol. Vis. Sci. 45:3796-805
79. Peyman GA, Moshfeghi DM, Moshfeghi A, Khoobehi B, Doiron DR, et al. 1997. Photodynamic therapy for choriocapillaris using tin ethyl etiopurpurin (SnET2). Ophthal. Surg. Lasers 28:409-17
80. Nguyen QD, Shah SM, Hafiz G, Quinlan E, Sung J, et al. 2006. 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 113:1522
81. Shah SM, Tatlipinar S, Quinlan E, Sung JU, Tabandeh H, et al. 2006. Dynamic and quantitative analysis of choroidal neovascularization by fluorescein angiography. Invest Ophthalmol. Vis. Sci. 47:5460-68
82. Spaide RF. 2006. Rationale for combination therapies for choroidal neovascularization. Am. J. Ophthalmol. 141:149-56
83. Kaiser PK. 2007. Verteporfin photodynamic therapy and antiangiogenic drugs: potential for combination therapy in exudative age-related macular degeneration. Curr. Med. Res. Opin. 23:477-87