Clinical safety of ranibizumab in age-related macular degeneration

Bibliography

• Seddon JM, Chen CA. The epidemiology of age-related macular degeneration. Int Ophthalmol Clin 2004;44:17-39
   PubMedGoogle Scholar
• Chopdar A, Chakravarthy U, Verma D. Age related macular degeneration. BMJ 2003;326:485-8
   PubMed Web of Science ®Google Scholar
• Ferris III FL, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol 1984;102:1640-2
   PubMed Web of Science ®Google Scholar
• Tezel TH, Bora NS, Kaplan HJ. Pathogenesis of age-related macular degeneration. Trends Mol Med 2004;10:417-20
   PubMed Web of Science ®Google Scholar
• Liakopoulos S, Ongchin S, Bansal A, Quantitative optical coherence tomography findings in various subtypes of neovascular age-related macular degeneration. Invest Ophthalmol Vis Sci 2008;49:5048-54
   PubMed Web of Science ®Google Scholar
• Bressler NM, Frost LA, Bressler SB, Natural course of poorly defined choroidal neovascularization associated with macular degeneration. Arch Ophthalmol 1988;106:1537-42
   PubMed Web of Science ®Google Scholar
• Bressler NM, Maguire MG, Murphy PL, Macular scatter (‘grid’) laser treatment of poorly demarcated subfoveal choroidal neovascularization in age-related macular degeneration. Results of a randomized pilot trial. Arch Ophthalmol 1996;114:1456-64
   PubMed Web of Science ®Google Scholar
• Macular Photocoagulation Study Group. Occult choroidal neovascularization. Influence on visual outcome in patients with age-related macular degeneration [erratum in Arch Ophthalmol 1996;114:1023]. Arch Ophthalmol 1996;114:400-12
   PubMed Web of Science ®Google Scholar
• Wong TY, Chakravarthy U, Klein R, The natural history and prognosis of neovascular age-related macular degeneration: a systematic review of the literature and meta-analysis. Ophthalmology 2008;115:116-26
   PubMed Web of Science ®Google Scholar
• Funk M, Karl D, Georgopoulos M. Neovascular age-related macular degeneration: intraocular cytokines and growth factors and the influence of therapy with ranibizumab. Ophthalmology 2009; In press
   Google Scholar
• Das A, McGuire PG. Retinal and choroidal angiogenesis: pathophysiology and strategies for inhibition. Prog Retin Eye Res 2003;22:721-48
   PubMed Web of Science ®Google Scholar
• Shima DT, Adamis AP, Ferrara N, Hypoxic induction of endothelial cell growth factors in retinal cells: identification and characterization of vascular endothelial growth factor (VEGF) as the mitogen. Mol Med 1995;1:182-93
   PubMed Web of Science ®Google Scholar
• Bhisitkul RB. Vascular endothelial growth factor biology: clinical implications for ocular treatments. Br J Ophthalmol 2006;90:1542-7
   PubMed Web of Science ®Google Scholar
• Kvanta A, Algvere PV, Berglin L, Seregard S. Subfoveal fibrovascular membranes in age-related macular degeneration express vascular endothelial growth factor. Invest Ophthalmol Vis Sci 1996;37:1929-34
   PubMed Web of Science ®Google Scholar
• Tong JP, Chan WM, Liu DT, Aqueous humor levels of vascular endothelial growth factor and pigment epithelium-derived factor in polypoidal choroidal vasculopathy and choroidal neovascularization. Am J Ophthalmol 2006;141:456-62
   PubMed Web of Science ®Google Scholar
• Gaudreault J, Fei D, Rusit J, Preclinical pharmacokinetics of Ranibizumab (rhuFabV2) after a single intravitreal administration. Invest Ophthalmol Vis Sci 2005;46:726-33
   PubMed Web of Science ®Google Scholar
• Rosenfeld PJ, Brown DM, Heier JS, Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006;355:1419-31
   PubMed Web of Science ®Google Scholar
• Brown DM, Kaiser PK, Michels M, Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006;355:1432-44
   PubMed Web of Science ®Google Scholar
• Brown DM, Michels M, Kaiser PK, Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology 2009;116:57-65
   PubMed Web of Science ®Google Scholar
• Mordenti J, Cuthbertson RA, Ferrara N, Comparisons of the intraocular tissue distribution, pharmacokinetics, and safety of 125I-labeled full-length and Fab antibodies in rhesus monkeys following intravitreal administration. Toxicol Pathol 1999;27:536-44
   PubMed Web of Science ®Google Scholar
• Lowe J, Araujo J, Yang J, Ranibizumab inhibits multiple forms of biologically active vascular endothelial growth factor in vitro and in vivo. Exp Eye Res 2007;85:425-30
   PubMed Web of Science ®Google Scholar
• Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev 1997;18:4-25
   PubMed Web of Science ®Google Scholar
• Galazios G, Papazoglou D, Tsikouras P, Kolios G. Vascular endothelial growth factor gene polymorphisms and pregnancy. J Matern Fetal Neonatal Med 2009;22:371-8
   PubMed Web of Science ®Google Scholar
• Maharaj AS, D'Amore PA. Roles for VEGF in the adult. Microvasc Res 2007;74:100-13
   PubMed Web of Science ®Google Scholar
• Haughney PC, Lowe J, Kearns A, Clinical pharmacokinetics of ranibizumab (Lucentis™) in subjects with AMD. Invest Ophthalmol Vis Sci 2005;46: E-abstract 1383
   Web of Science ®Google Scholar
• Novartis Pharma AG. Lucentis (ranibizumab): summary of product characteristics. Novartis Pharma AG: Basel, Switzerland; 2008
   Google Scholar
• Genentech Inc. Avastin (bevacizumab): prescribing Information. Genentech Inc.: San Francisco, California, USA. 2008
   Google Scholar
• Royal College of Ophthalmologists. Ranibizumab: the clinician's guide to commencing, continuing and discontinuing treatment. 2008. Available from: http://www.rcophth.ac.uk/docs/scientific/Ranibizumab_-_June_2008.pdf. [Last accessed 22 July 2009]
   Google Scholar
• Antoszyk AN, Tuomi L, Chung CY, Singh A. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results. Am J Ophthalmol 2008;145:862-74
   PubMed Web of Science ®Google Scholar
• Heier JS, Boyer DS, Ciulla TA, Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration: year 1 results of the FOCUS Study. Arch Ophthalmol 2006;124:1532-42
   PubMed Web of Science ®Google Scholar
• Heier JS, Antoszyk AN, Pavan PR, Ranibizumab for treatment of neovascular age-related macular degeneration: a phase I/II multicenter, controlled, multidose study. Ophthalmology 2006;113:633-4
   PubMed Web of Science ®Google Scholar
• Rosenfeld PJ, Schwartz SD, Blumenkranz MS, Maximum tolerated dose of a humanized anti-vascular endothelial growth factor antibody fragment for treating neovascular age-related macular degeneration. Ophthalmology 2005;112:1048-53
   PubMed Web of Science ®Google Scholar
• Rosenfeld PJ, Heier JS, Hantsbarger G, Shams N. Tolerability and efficacy of multiple escalating doses of ranibizumab (lucentis) for neovascular age-related macular degeneration. Ophthalmology 2006;113:623-32
   PubMed Web of Science ®Google Scholar
• Kwon O, Lee F, Chung H, Safety and efficacy of ranibizumab in Asian patients with neovascular age-related macular degeneration: 4- and 12-months results of the EXTEND III study. Invest Ophthalmol Vis Sci 2009;50: E-abstract 2365
   Google Scholar
• Regillo CD, Brown DM, Abraham P, Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 1. Am J Ophthalmol 2008;145:239-48
   PubMed Web of Science ®Google Scholar
• Schlingemann RO, Schmidt-Erfurth U, Eldem B, Safety and efficacy of quarterly vs. monthly ranibizumab injections in patients with neovascular age-related macular degeneration: 12-months results of the EXCITE study. Invest Ophthalmol Vis Sci 2009;50: E-abstract 2382
   PubMedGoogle Scholar
• Singer M, Wong P, Wang P-W, Scott L. HORIZON extension trial of ranibizumab (LUCENTIS®) for neovascular age-related macular degeneration (AMD): two-year safety and efficacy results. Invest Ophthalmol Vis Sci 2009;50: E-abstract 3093
   Google Scholar
• Regillo CD, Francom S, Rubio RG. Ranibizumab safety in wet AMD: SAILOR Study results. Presented at the Joint Meeting of the American Academy of Ophthalmology (AAO) and the European Scoiety of Ophthalmology (SOE), Atlanta, Georgia, USA. 8 – 11 November 2008
   Google Scholar
• Boyer DS, Heier JS, Brown DM, A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology 2009;116:1731-9
   PubMed Web of Science ®Google Scholar
• Meyer CH, Eter N, Holz FG, SUSTAIN Study Group. Ranibizumab in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Interim results from the SUSTAIN Trial. Invest Ophthalmol Vis Sci 2008;49:273
   Google Scholar
• Holz FG, Meyer C, Eter N. Safety and efficacy of ranibizumab treatment in patients with neovascular age-related macular degeneration: 12-nonth results of the SUSTAIN study. Invest Ophthalmol Vis Sci 2009;50: E-Abstract 3095
   Google Scholar
• Schmidt-Erfurth U, Wolf S, Study Group. Same-day administration of verteporfin and ranibizumab 0.5 mg in patients with choroidal neovascularization due to age-related macular degeneration. Br J Ophthalmol 2008;92:1628-35
   PubMed Web of Science ®Google Scholar
• Pruente C, Hatz K, Henrich PB, A randomized double-masked study comparing lucentis monotherapy and PDT combined with lucentis therapy in patients with exudative AMD: one year results for BCVA and retreatment frequency. Invest Ophthalmol Vis Sci 2009;50: E-abstract 5224
   Google Scholar
• Bailey CC, Banerjee S, Mandal K, Cole A. A randomised prospective double-masked exploratory study comparing combination photodynamic treatment and intravitreal ranibizumab vs. intravitreal ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration. Invest Ophthalmol Vis Sci 2009;50: E-abstract 1905
   Google Scholar
• Larsen BP, Mudvari SS, MacCumber MWMPT. Combination Lucentis and Ocular photodynamic therapy with Visudyne, with Evaluation-based Retreatments (CLOVER) trial. Invest Ophthamol Vis Sci 2009;50: E-Abstract 1921
   Google Scholar
• Chen E, Brown DM, Wong TP, The LUV trial: ultra-low fluence verteporfin (VISUDYNE®) photodynamic therapy (vPDT) combined with intravitreal ranibizumab (LUCENTIS®) versus ranibizumab monotherapy. Invest Ophthalmol Vis Sci 2009;50: E-abstract 1920
   Google Scholar
• Slakter JS, DENALI Study Group. SUMMIT: combination therapy with verteporfin PDT and ranibizumab for subfoveal choroidal neovascularization due to AMD. Invest Ophthalmol Vis Sci 2007;48: E-abstract 1817
   Google Scholar
• Tano Y, EXTEND study group. The safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration: 12-month results from the phase I/II EXTEND-I study. Invest Ophthalmol Vis Sci 2008;49: E-abstract 272
   Google Scholar
• Rothenbuehler SP, Waeber D, Brinkmann CK, Effects of ranibizumab in patients with subfoveal choroidal neovascularization attributable to age-related macular degeneration. Am J Ophthalmol 2009;147:831-7
   PubMed Web of Science ®Google Scholar
• Chang LK, Sarraf D. Tears of the retinal pigment epithelium: an old problem in a new era. Retina 2007;27:523-34
   PubMed Web of Science ®Google Scholar
• Chiang A, Chang LK, Yu F, Sarraf D. Predictors of anti-VEGF-associated retinal pigment epithelial tear using FA and OCT analysis. Retina 2008;28:1265-9
   PubMed Web of Science ®Google Scholar
• Diago T, McCannel CA, Bakri SJ, Infectious endophthalmitis after intravitreal injection of antiangiogenic agents. Retina 2009;29:601-5
   PubMed Web of Science ®Google Scholar
• Driscoll SJ, Klein KS, Walsh M, Multicenter study of endophthalmitis after intravitreal injection of anti-vascular endothelial growth factor agents. Invest Ophthalmol Vis Sci 2009;50: E-Abstract 6185
   Google Scholar
• Fintak DR, Shah GK, Blinder KJ, Incidence of endophthalmitis related to intravitreal injection of bevacizumab and ranibizumab. Retina 2008;28:1395-9
   PubMed Web of Science ®Google Scholar
• Garg S, Brod R, Kim D, Retinal pigment epithelial tears after intravitreal bevacizumab injection for exudative age-related macular degeneration. Clin Exp Ophthalmol 2008;36:252-6
   PubMed Web of Science ®Google Scholar
• Kim JE, Mantravadi AV, Hur EY, Covert DJ. Short-term intraocular pressure changes immediately after intravitreal injections of anti-vascular endothelial growth factor agents. Am J Ophthalmol 2008;146:930-4
   PubMed Web of Science ®Google Scholar
• Ladas ID, Karagiannis DA, Rouvas AA, Safety of repeat intravitreal injections of bevacizumab versus ranibizumab: our experience after 2,000 injections. Retina 2009;29:313-8
   PubMed Web of Science ®Google Scholar
• Pilli S, Kotsolis A, Spaide RF, Endophthalmitis associated with intravitreal anti-vascular endothelial growth factor therapy injections in an office setting. Am J Ophthalmol 2008;145:879-82
   PubMed Web of Science ®Google Scholar
• Smith BT, Kraus CL, Apte RS. Retinal pigment epithelial tears in ranibizumab-treated eyes. Retina 2009;29:335-9
   PubMed Web of Science ®Google Scholar
• Larson TA, Bakri SJ, McCannel CA, The effect of ranibizumab (Lucentis) on intraocular pressure. Invest Ophthalmol Vis Sci 2009;50: E-abstract 1896
   Google Scholar
• Georgalas I, Papaconstantinou D, Tservakis I, Severe hypotony and filtering bleb leak after intravitreal injection of ranibizumab. Ther Clin Risk Manag 2009;5:17-9
   PubMedGoogle Scholar
• Coote MA, Ruddle JB, Qin Q, Crowston JG. Vascular changes after intra-bleb injection of bevacizumab. J Glaucoma 2008;17:517-8
   PubMed Web of Science ®Google Scholar
• Kiss CG, Simader C, Michels S, Schmidt-Erfurth U. Combination of verteporfin photodynamic therapy and ranibizumab: effects on retinal anatomy, choroidal perfusion and visual function in the protect study. Br J Ophthalmol 2008;92:1620-7
   PubMed Web of Science ®Google Scholar
• Scappaticci FA, Skillings JR, Holden SN, Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst 2007;99:1232-9
   PubMed Web of Science ®Google Scholar
• Narukawa M, Yafune A, Takeuchi M. Observation of time-dependent adverse events and the influence of drop-out thereon in long-term safety studies–simulation study under the current practice of post-marketing safety evaluation in Japan. J Biopharm Stat 2004;14:403-14
   PubMedGoogle Scholar
• Antiplatelet Trialists' Collaboration. Collaborative overview of randomised trials of antiplatelet therapy–I: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ 1994;308:81-106
   PubMed Web of Science ®Google Scholar
• Boyer DS, Chung CY, Tuomi L. A safety overview of ranibizumab in patients with wet AMD: ANCHOR, MARINA, PIER, and SAILOR Studies. Presented at the American Academy of Ophthalmology (AAO) 2008 Annual Meeting, Atlanta, Georgia, USA. 8 – 11 November 2008
   Google Scholar
• Nalluri SR, Chu D, Keresztes R, Risk of venous thromboembolism with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis. JAMA 2008;300:2277-85
   PubMed Web of Science ®Google Scholar
• Wilson PW, D'Agostino RB, Levy D, Prediction of coronary heart disease using risk factor categories. Circulation 1998;97:1837-47
   PubMed Web of Science ®Google Scholar
• Lewington S, Clarke R, Qizilbash N, Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-13
   PubMed Web of Science ®Google Scholar
• Chakravarthy U, Augood C, Bentham GC, Cigarette smoking and age-related macular degeneration in the EUREYE Study. Ophthalmology 2007;114:1157-63
   PubMed Web of Science ®Google Scholar
• Fraser-Bell S, Wu J, Klein R, Cardiovascular risk factors and age-related macular degeneration: the Los Angeles Latino Eye Study. Am J Ophthalmol 2008;145:308-16
   PubMed Web of Science ®Google Scholar
• Klein R, Klein BE, Tomany SC, Cruickshanks KJ. The association of cardiovascular disease with the long-term incidence of age-related maculopathy: the Beaver Dam Eye Study. Ophthalmology 2003;110:1273-80
   PubMed Web of Science ®Google Scholar
• Eye Disease Case-Control Study Group. Risk factors for neovascular age-related macular degeneration. Arch Ophthalmol 1992;110:1701-8
   PubMed Web of Science ®Google Scholar
• Curcio CA, Millican CL, Bailey T, Kruth HS. Accumulation of cholesterol with age in human Bruch's membrane. Invest Ophthalmol Vis Sci 2001;42:265-74
   PubMed Web of Science ®Google Scholar
• Pauleikhoff D, Chen JC, Chisholm IH, Bird AC. Choroidal perfusion abnormality with age-related bruch's membrane change. Am J Ophthalmol 1990;109:211-7
   PubMed Web of Science ®Google Scholar
• Vingerling JR, Dielemans I, Bots ML, Age-related macular degeneration is associated with atherosclerosis. The Rotterdam study. Am J Epidemiol 1995;142:404-9
   PubMed Web of Science ®Google Scholar
• Zarbin MA. Age-related macular degeneration: review of pathogenesis. Eur J Ophthalmol 1998;8:199-206
   PubMed Web of Science ®Google Scholar
• Wong TY, Klein R, Sun C, Age-related macular degeneration and risk for stroke. Ann Intern Med 2006;145:98-106
   PubMed Web of Science ®Google Scholar
• Wong TY, Tikellis G, Sun C, Age-related macular degeneration and risk of coronary heart disease: the Atherosclerosis Risk in Communities study. Ophthalmology 2007;114:86-91
   PubMed Web of Science ®Google Scholar
• Liew G, Mitchell P. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2007;356:747-8
   PubMed Web of Science ®Google Scholar
• Mitchell P, Smith W, Attebo K, Wang JJ. Prevalence of age-related maculopathy in Australia. The Blue Mountains Eye study. Ophthalmology 1995;102:1450-60
   PubMed Web of Science ®Google Scholar
• Rosenfeld PJ, Brown DM, Schneider S, for the MARINA and ANCHOR Study Groups. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2007;356:749-50
   Web of Science ®Google Scholar
• Buggage RR, Xu X, Cruess AF, Clinical characteristics and impact of neovascular age-related macular degeneration on medical status, daily living, functioning, and health resource utilization: a survey of five countries. Invest Ophthalmol Vis Sci 2006;47: E-abstract 2208
   PubMedGoogle Scholar
• Alexander SL, Linde-Zwirble WT, Werther W, Annual rates of arterial thromboembolic events in medicare neovascular age-related macular degeneration patients. Ophthalmology 2007;114:2174-8
   PubMed Web of Science ®Google Scholar
• Scott IU, Mo J, Klein R, Association between neovascular age–related macular degeneration and incident myocardial infarction (MI). Invest Ophthalmol Vis Sci 2006;47: E-abstract 2196
   Web of Science ®Google Scholar
• West ES, Werther W, Napalkov P, Myocardial infarction and cerebrovascular accident rates in patients with neovascular age-related macular degeneration in a healthcare claims database. Presented at the 24th Annual American Society of Retina Specialists (ASRS) and 6th Annual European Vitreoretinal Society (EVRS) Combined Meeting, Cannes, France. 9 – 13 September 2006
   Google Scholar
• Nguyen-Khoa BA, Goehring EL Jr, Werther W, Hospitalized cardiovascular diseases in neovascular age-related macular degeneration. Arch Ophthalmol 2008;126:1280-6
   PubMed Web of Science ®Google Scholar
• Genentech Inc. Letter to healthcare providers. 2007. Available from: http://www.gene.com/gene/products/information/pdf/healthcare-provider-letter.pdf. [Last accessed 23 July 2009]
   Google Scholar
• Busbee BG, Awh CC, Sonkin PL, Gutow GS. Efficacy and safety of 1.0mg ranibizmab for age-related macular degeneration: interim analysis of a prospective investigator sponsored trial. Invest Ophthalmol Vis Sci 2009;50: E-abstract 2356
   Google Scholar