New therapies for neovascular age-related macular degeneration: Critical appraisal of the current evidence

Acta Ophthalmologica Scandinavica

Volumn 85, Issue 1, 2007, Pages 6-20

  Virgili, Gianni ^a   Do, Diana V ^b   Bressler, Neil M ^b   Menchini, Ugo ^a  

^a UNIVERSITY OF FLORENCE   (Italy)

^b JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Age related macular Degeneration; Choroidal neovascularization; Evidence based medicine; Laser photocoagulation; Pegaptanib sodium; Verteporfin therapy

Indexed keywords

ADENOVIRUS VECTOR; AGENTS ACTING ON THE EYE; ALPHA TOCOPHEROL; ANECORTAVE; ANGIOGENESIS INHIBITOR; ANTIINFLAMMATORY AGENT; ANTIOXIDANT; ASCORBIC ACID; BENZOPORPHYRIN DERIVATIVE; BETA CAROTENE; BEVACIZUMAB; CAND 5; EVIZON; PEGAPTANIB; PHOTOSENSITIZING AGENT; PHOTREX; PIGMENT EPITHELIUM DERIVED FACTOR; PLACEBO; RANIBIZUMAB; ROSTAPORFIN; SMALL INTERFERING RNA; SQUALAMINE; TRIAMCINOLONE ACETONIDE; UNCLASSIFIED DRUG; VATALANIB; ZINC;

ACCURACY; BLOOD PRESSURE; BLURRED VISION; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CONJUNCTIVAL HEMORRHAGE; DATA ANALYSIS; DISEASE SEVERITY; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; ENDOPHTHALMITIS; EVIDENCE BASED MEDICINE; EXTERNAL BEAM RADIOTHERAPY; EYE PAIN; FOLLOW UP; HUMAN; INJECTION SITE REACTION; INTERMETHOD COMPARISON; INTRAOCULAR PRESSURE; IRIS DISEASE; LASER COAGULATION; LENS DISEASE; MEDICAL DECISION MAKING; MEDICAL RESEARCH; META ANALYSIS; MONOTHERAPY; NONHUMAN; NONVIRAL GENE THERAPY; OUTCOME ASSESSMENT; PATHOGENESIS; PHOTODYNAMIC THERAPY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; RETINA DETACHMENT; RETINA MACULA AGE RELATED DEGENERATION; RETINA SURGERY; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; SUBRETINAL NEOVASCULARIZATION; SYSTEMATIC REVIEW; TRANSPUPILLARY THERMOTHERAPY; TREATMENT DURATION; UVEA DISEASE; UVEITIS; VALIDITY; VIRAL GENE DELIVERY SYSTEM; VISUAL ACUITY; VISUAL IMPAIRMENT;

ANGIOGENESIS INHIBITORS; CHOROIDAL NEOVASCULARIZATION; CLINICAL TRIALS; EVIDENCE-BASED MEDICINE; GLUCOCORTICOIDS; HUMANS; MACULAR DEGENERATION; OPHTHALMOLOGIC SURGICAL PROCEDURES; PHOTOSENSITIZING AGENTS;

EID: 33846457882     PISSN: 13953907     EISSN: 16000420     Source Type: Journal    
DOI: 10.1111/j.1600-0420.2006.00711.x     Document Type: Review

References (81)

1. Adamis AP, Miller JW, Bernal MT, D'Amico DJ, Folkman J, Yeo TK & Yeo KT (1994): Increased vascular endothelial growth factor levels in the vitreous of eyes with proliferative diabetic retinopathy. Am J Ophthalmol 118: 445-450.
2. Age-related Eye Disease Study Research Group (2001): A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene and zinc for age-related macular degeneration and vision loss. AREDS Report 8. Arch Ophthalmol 119: 1417-1436.
3. Ahuja RM, Benner JD, Schwartz JC, Butler JW & Steidl SM (2001): Efficacy of transpupillary thermotherapy (TTT) in the treatment of occult subfoveal choroidal neovascularization in age-related macular degeneration. Semin Ophthalmol 16: 81-85.
4. Algvere PV, Libert C & Seregard S (2001): Transpupillary thermotherapy of occult CNV with no or minimally classic CNV in age-related macular degeneration. Semin Ophthalmol 16: 90-96.
5. Beatty S, Koh H, Phil M, Henson D & Boulton M (2000): The role of oxidative stress in the pathogenesis of age-related macular degeneration. Surv Ophthalmol 45: 115-134.
6. Buch H, Vinding T, La Cour M, Appleyard M, Jensen GB & Nielsen NV (2004): Prevalence and causes of visual impairment and blindness among 9980 Scandinavian adults: The Copenhagen City Eye Study. Ophthalmology 111: 53-61.
7. Castellani A, Pace GP & Concioli M (1963): Photodynamic effect of haematoporphyrin on blood microcirculation. J Pathol Bacteriol 86: 99-102.
8. Challa JK, Gillies MC, Penfold PL, Gyory JF, Hunyor AB & Billson FA (1998): Exudative macular degeneration and intravitreal triamcinolone: 18 month follow up. Aust N Z J Ophthalmol 26: 277-281.
9. Ciulla TA, Criswell MH, Danis RP, Williams JI, McLane MP & Holroyd KJ (2003): Squalamine lactate reduces choroidal neovascularization in a laser-injury model in the rat. Retina 23: 808-814.
10. Congdon N, O'Colmain B, Klaver CC et.al. (2004): Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol 122: 477-485.
11. Cook DI, Gebski VJ & Keech AC (2004): Subgroup analysis in clinical trials. Med J Aust 180: 289-291.
12. D'Amico DJ, Duker J, Regillo C, Schneebaum C & Beasley C (2002): Anecortave acetate administered sub-Tenon's retrobulbar with and without Visudyne PDT in patients with subfoveal age-related macular degeneration (AMD): Clinical safety profile. E-Abstract 569. Invest Ophthalmol Vis Sci 43.
13. D'Amico DJ, Goldberg MF, Hudson H et.al. (2003): Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: Twelve-month clinical outcomes. Ophthalmology 110: 2372-2383.
14. Danis RP, Ciulla TA, Pratt LM & Anliker W (2000): Intravitreal triamcinolone acetonide in exudative age-related macular degeneration. Retina 20: 244-250.
15. Desatnik H, Treister G, Alhalel A, Krupsky S & Moisseiev J (2000): ICGA-guided laser photocoagulation of feeder vessels of choroidal neovascular membranes in age-related macular degeneration. Indocyanine green angiography. Retina 20: 143-150.
16. Dimitrov PN, Mukesh BN, McCarty CA & Taylor HR (2003): Five-year incidence of bilateral cause-specific visual impairment in the Melbourne Visual Impairment Project. Invest Ophthalmol Vis Sci 44: 5075-5081.
17. Folkman J (1971T: Tumour angiogenesis: therapeutic implications. N Engl J Med 285: 1182-1186.
18. Foran S, Wang JJ & Mitchell P (2003): Causes of visual impairment in two older population cross-sections: The Blue Mountains Eye Study. Ophthalmic Epidemiol 10: 215-225.
19. Garcia GA, Quiroz-Mercado H, Uwaydat S et.al. (2004): A phase I/II trial of intravenous squalamine lactate for treatment of choroidal neovascularization in age-related macular degeneration (ARMD). E-Abstract 2362. Invest Ophthalmol Vis Sci 45.
20. Gillies MC, Simpson JM, Luo W, Penfold P, Hunyor AB, Chua W, Mitchell P & Billson F (2003): A randomized clinical trial of a single dose of intravitreal triamcinolone acetonide for neovascular agerelated macular degeneration: One-year results. Arch Ophthalmol 121: 667-673.
21. Gragoudas ES, Adamis AP, Cunningham ET Jr, Feinsod M & Guyer DR (2004): Pegaptanib for neovascular age-related macular degeneration. N Engl J Med 351: 2805-2816.
22. Harbour R & Miller J (2001): A new system for grading recommendations in evidence based guidelines. BMJ 323: 334-336.
23. Hawkins BS (1999)W The CONSORT statement: will it lead to improved reporting of clinical trials in ophthalmology? Consolidated Standards Reporting Trials. Arch Ophthalmol 117: 677-680.
24. Heier JS & FOCUS Study Group (2005): Intravitreal ranibizumab with verteporfin photodynamic therapy for neovascular age-related macular degeneration: Year one results. Presented at the American Society of Retina Specialists 23rd Annual Meeting, July 16-20, 2005, Montreal, Canada.
25. Heier JS, Rosenfeld PJ, Antoszyk AN, Hantsbarger G, Kim R & Shams N (2005): Long-term experience with Lucentis (ranibizumab) in patients with neovascular age-related macular degeneration (AMD). E-Abstract 1393. Invest Ophthalmol Vis Sci 46.
26. Heier JS, Sy JR, McCluskey ER & rhuFab V2 Study Group (2003): RhuFab V2 in wet AMD -6 month continued improvement following multiple intravitreal injections. E-Abstract 972. Invest Ophthalmol Vis Sci 44.
27. Higgins RD, Sanders RJ, Yan Y, Zasloff M & Williams JI (2000): Squalamine improves retinal neovascularization. Invest Ophthalmol Vis Sci 41: 1507-1512.
28. Hudson HL, Fish GE, Dahlin D, Carvalho C, Faulkner RD, Curtis MA & Robertson SM (2005): Clinical outcomes of two open-label pharmacokinetic studies with anecortave acetate in patients with exudative age-related macular degeneration (AMD). E-Abstract 1375. Invest Ophthalmol Vis Sci 46.
29. Jonas JB, Degenring RF, Kreissig I & Akkoyun I (2004): Duration of the effect of intravitreal triamcinolone acetonide as treatment of exudative age-related macular degeneration. E-Abstract 1938. Invest Ophthalmol Vis Sci 45.
30. Jonas JB, Kreissig I, Hugger P, Sauder G, Panda-Jonas S & Degenring R (2003): Intravitreal triamcinolone acetonide for exudative age related macular degeneration. Br J Ophthalmol 87: 462-468.
31. Kim JE, Perkins SL, Schwiesow T, Connor TB Jr & Han DP (2001): Transpupillary thermotherapy of occult choroidal neovascularization in age related macular degeneration. Semin Ophthalmol 16: 86-89.
32. Kim MY & Xue X (2004): Likelihood ratio and a Bayesian approach were superior to standard noninferiority analysis when the noninferiority margin varied with the control event rate. J Clin Epidemiol 57: 1253-1261.
33. 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: 182-191.
34. Kramer M, Miller JW, Michaud N, Moulton RS, Hasan T, Flotte TJ & Gragoudas ES (1996): Liposomal benzoporphyrin derivative verteporfin photodynamic therapy. Selective treatment of choroidal neovascularization in monkeys. Ophthalmology 103: 427-438.
35. Lee WK & Kim HK (2000): Feeder vessel laser photocoagulation of subfoveal choroidal neovascularization. Korean J Ophthalmol 14: 60-68.
36. Lewis H (2001): Macular translocation with chorAoscleral outfolding: a pilot clinical study. Am J Ophthalmol 132: 156-163.
37. Liang FQ & Godley BF (2003): Oxidative stress-induced mitochondrial DNA damage in human retinal pigment epithelial cells: A possible mechanism for RPE aging and age-related macular degeneration. Exp Eye Res 76: 397-403.
38. TLim L & Guymer RH (2004): AMD: to supplement or not? Clin Exp Ophthalmol 32: 341-343.
39. Macular Photocoagulation Study Group (1982): Argon laser photocoagulation for senile macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol 100: 912-918.
40. Macular Photocoagulation Study Group (1990): Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol 108: 816-824.
41. Macular Photocoagulation Study Group (1991a): Argon laser photocoagulation for neovascular maculopathy. Five-year results from randomized clinical trials. Arch Ophthalmol 109: 1109-1114.
42. Macular Photocoagulation Study Group (1991b): Laser photocoagulation of subfoveal neovascular lesions in age-related macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol 109: 1220-1231.
43. Macular Photocoagulation Study Group (1991c): Laser photocoagulation of subfoveal recurrent neovascular lesions in age-related macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol 109: 1232-1241.
44. 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: 1200-1209.
45. Macular Photocoagulation Study Group (1994a): Laser photocoagulation for juxtafoveal choroidal neovascularization. Five-year results from randomized clinical trials. Arch Ophthalmol 112: 500-509.
46. Macular Photocoagulation Study Group (1994b): 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: 480-488.
47. Macular Photocoagulation Study Group (1996): Occult choroidal neovascularization. Influence on visual outcome in patients with age-related macular degeneration. Arch Ophthalmol 114: 400-412.
48. Miller J, Chung CY, Kim RY & MARINA Study Group (2005): Randomized, controlled phase III study of ranibizumab (Lucentis) for minimally classic or occult neovascular age-related macular degeneration. Presented at the American Society of Retina Specialists 23rd Annual Meeting, July 16-20, 2005, Montreal, Canada.
49. Miller JW, Walsh AW, Kramer M, Hasan T, Michaud N, Flotte TJ, Haimovici R & Gragoudas ES (1995): Photodynamic therapy of experimental choroidal neovascularization using lipoprotein-delivered benzoporphyrin. Arch Ophthalmol 113: 810-818.
50. Moher D, Schulz KF & Altman DG (2003): The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Clin Oral Invest 7: 2-7.
51. Pauleikhoff D, Bornfeld N, Gabel VP, Holz F & Roider H (2005): The position of the Retinological Society, the German Ophthalmological Society and the Professional Association of Ophthalmologists - comments on the current therapy for neovascular AMD. Klin Monatsbl Augenheilkd 222: 381-388.
52. Penfold PL, Gyory JF, Hunyor AB & Billson FA (1995): Exudative macular degeneration and intravitreal triamcinolone. A pilot study. Aust N Z J Ophthalmol 23: 293-298.
53. Pieramici DJ, de Juan E Jr, Fujii GY, Reynolds SM, Melia M, Humayun MS, Schachat AP & Hartranft CD (2000): Limited inferior macular translocation for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration. Am J Ophthalmol 130: 419-428.
54. Radiation Therapy for Age-related Macular Degeneration (1999): A prospective, randomized, double-masked trial on radiation therapy for neovascular age-related macular degeneration (RAD Study). Ophthalmology 106: 2239-2247.
55. Ranson NT, Danis RP, Ciulla TA & Pratt L (2002): Intravitreal triamcinolone in subfoveal recurrence of choroidal neovascularisation after laser treatment in macular degeneration. Br J Ophthalmol 86: 527-529.
56. Rechtman E, Danis RP, Pratt LM & Harris A (2004): Intravitreal triamcinolone with photodynamic therapy for subfoveal choroidal neovascularization in age related macular degeneration. Br J Ophthalmol 88: 344-347.
57. Reichel E (2004): Transpupillary Thermotherapy. Presented at AAO Retina Subspecialty Day, 22-23 October 2004, New Orleans.
58. Rosenfeld PJ (2005): Avastin for AMD. Presented at AAO Retina Subspecialty Day, 15-18 October 2005, Chicago.
59. Sanchez-Thorin JC, Cortes MC, Montenegro M & Villate N (2001): The quality of reporting of randomized clinical trials published in Ophthalmology. Ophthalmology 108: 410-415.
60. Shiraga F, Ojima Y, Matsuo T, Takasu I & Matsuo N (1998): Feeder vessel photocoagulation of subfoveal choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology 105: 662-669.
61. Sivagnanavel V, Evans J, Ockrim Z & Chong V (2004): Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev CD004004. http://www.mrw.interscience.wiley.com/cochrane/clsysrev/ articles/CD004004/frame.html: Accessed May 2006
62. Slakter JS, Bochow T, D'Amico DJ, Marks B, Jerdan J, Sullivan EK & Anecortave Acetate Clinical Study Group (2006): Anecortave acetate (15 milligrams) versus photodynamic therapy for treatment of subfoveal neovascularization in age-related macular degeneration. Ophthalmology 113: 3-13.
63. Spaide RF, Sorenson J & Maranan L (2003): Combined photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide for choroidal neovascularization. Ophthalmology 110: 1517-1525.
64. Spaide RF, Sorenson J & Maranan L (2005): Photodynamic therapy with verteporfin combined with intravitreal injection of triamcinolone acetonide for choroidal neovascularization. Ophthalmology 112: 301-304.
65. Submacular Surgery Trials (SST) Research Group (2004a): Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: Ophthalmic findings: SST Report 11. Ophthalmology 111: 1967-1980.
66. Submacular Surgery Trials (SST) Research Group (2004b): Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: Ophthalmic findings: SST Report 13. Ophthalmology 111: 1993-2006.
67. Thomas EL, Danis RP & SnET2 Study Group (2004): Visual acuity outcomes of SnET2 photodynamic therapy for occult choroidal neovascular membranes. Presented at the American Academy of Ophthalmology and European Society of Ophthalmology 2004 Joint Meeting, 23-26 October 2004, New Orleans.
68. Thomas EL & SnET2 Study Group (2004): SnET2 photodynamic therapy for age-related macular degeneration: Visual acuity efficacy outcomes from two parallel phase III trials. E-Abstract 2214. Invest Ophthalmol Vis Sci 45.
69. Tranos P, Singh M, Peter NM, Dhir L, Kon C & Rassam S (2004): Transpupillary thermotherapy for the treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration. Acta Ophthalmol Scand 82: 585-590.
70. Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) and Verteporfin in Photodynamic Therapy (VIP) Study Groups (2003): Effect of lesion size, visual acuity, and lesion composition on visual acuity change with and without verteporfin therapy for choroidal neovascularization secondary to age-related macular degeneration-TAP and VIP Report 1. Am J Ophthalmol 136: 407-418.
71. Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) and Verteporfin in Photodynamic Therapy (VIP) Study Groups (2004a): Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: Meta-analysis of 2-year safety results in three randomized clinical trials. TAP and VIP Report 4. Retina 24: 1-12.
72. Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) and Verteporfin in Photodynamic Therapy (VIP) Study Groups (2004b): Acute severe visual acuity decrease after photodynamic therapy with verteporfin: Case reports from randomized clinical trials-TAP and VIP Report 3. Am J Ophthalmol 137: 683-696.
73. 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: 1329-1345.
74. Treatment of Age-related Macular Degeneration with Photodynamic Therapy (TAP) Study Group (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.
75. Treatment of Age-related Macular Degeneration with Photodynamic Therapy (TAP) Study Group (2006): Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: 5-year results of 2 randomized clinical trials with an open-label extension-TAP Report 8. Graefes Arch Clin Exp Ophthalmol [Epub ahead of print].
76. Verteporfin in Photodynamic Therapy (VIP) Study Group (2001a): 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-VIP Report 2. Am J Ophthalmol 131: 541-560.
77. Verteporfin in Photodynamic Therapy (VIP) Study Group (2001b): Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin: 1-year results of a randomized clinical trial-VIP Report 1. Ophthalmology 108: 841-852.
78. Verteporfin in Photodynamic Therapy (VIP) Study Group (2003): Verteporfin therapy of subfoveal choroidal neovascularization in pathologic myopia: 2-year results of a randomized clinical trial-VIP Report 3. Ophthalmology 110: 667-673.
79. Vingerling JR, Dielemans I, Hofman A, Grobbee DE, Hijimering M, Kramer CF & de Jong PT (1995): The prevalence of age-related maculopathy in the Rotterdam Study. Ophthalmology 102: 205-210.
80. Visudyne in Minimally Classic CNV (VIM) Study Group (2005): Verteporfin therapy of subfoveal minimally classic choroidal neovascularization in age-related macular degeneration: 2-year results of a randomized clinical trial. Arch Ophthalmol 123: 448-457.
81. Weishaupt KR, Gomer CJ & Dougherty TJ (1976): Identification of singlet oxygen as the cytotoxic agent in photoinactivation of a murine tumor. Cancer Res 36: 2326-2329.