A safety evaluation of ranibizumab in the treatment of age-related macular degeneration

Bibliography

• Bunce C, Xing W, Wormald R. Causes of blind and partial sight certifications in England and Wales: april 2007-march 2008. Eye 2010;24(11):1692-9
   PubMed Web of Science ®Google Scholar
• National Institute of Clinical Excellence. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. London: National Institute of Clinical Excellence 2008. Available from: http://www.nice.org.uk/nicemedia/pdf/TA155guidance.pdf [Last accessed 2 June 2014]
   Google Scholar
• Keenan TD, Kelly SP, Sallam A, et al. Incidence and baseline clinical characteristics of treated neovascular age-related macular degeneration in a well-defined region of the UK. Br J Ophthalmol 2013;97(9):1168-72
   PubMed Web of Science ®Google Scholar
• Bloch SB, Larsen M, Munch IC. Incidence of legal blindness from age-related macular degeneration in Denmark: year 2000 to 2010. Am J Ophthalmol 2012;153(2):209-13. e202
   PubMed Web of Science ®Google Scholar
• Skaat A, Chetrit A, Belkin M, et al. Time trends in the incidence and causes of blindness in Israel. Am J Ophthalmol 2012;153(2):214-21. e211
   PubMed Web of Science ®Google Scholar
• Gordon MS, Margolin K, Talpaz M, et al. Phase I safety and pharmacokinetic study of recombinant human anti-vascular endothelial growth factor in patients with advanced cancer. J Clin Oncol 2001;19(3):843-50
   PubMed Web of Science ®Google Scholar
• Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350(23):2335-42
   PubMed Web of Science ®Google Scholar
• Gragoudas ES, Adamis AP, Cunningham ET Jr, Group VISiONCT. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med 2004;351(27):2805-16
   PubMed Web of Science ®Google Scholar
• Michels S, Rosenfeld PJ, Puliafito CA, et al. Systemic bevacizumab (avastin) therapy for neovascular age-related macular degeneration twelve-week results of an uncontrolled open-label clinical study. Ophthalmology 2005;112(6):1035-47
   PubMed Web of Science ®Google Scholar
• Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging 2005;36(4):331-5
   PubMed Web of Science ®Google Scholar
• Shahar J, Avery RL, Heilweil G, et al. Electrophysiologic and retinal penetration studies following intravitreal injection of bevacizumab (avastin). Retina 2006;26(3):262-9
   PubMed Web of Science ®Google Scholar
• Fung AE, Rosenfeld PJ, Reichel E. The international intravitreal bevacizumab safety survey: using the internet to assess drug safety worldwide. Br J Ophthalmol 2006;90(11):1344-9
   PubMed Web of Science ®Google Scholar
• Kim LA, D’Amore PA. A brief history of anti-vegf for the treatment of ocular angiogenesis. Am J Pathol 2012;181(2):376-9
   PubMed Web of Science ®Google Scholar
• Meyer CH, Holz FG. Preclinical aspects of anti-vegf agents for the treatment of wet amd: ranibizumab and bevacizumab. Eye (Lond) 2011;25(6):661-72
   PubMed Web of Science ®Google Scholar
• Holash J, Davis S, Papadopoulos N, et al. Vegf-trap: a vegf blocker with potent antitumor effects. Proc Natl Acad Sci USA 2002;99(17):11393-8
   PubMed Web of Science ®Google Scholar
• Husain D, Kim I, Gauthier D, et al. Safety and efficacy of intravitreal injection of ranibizumab in combination with verteporfin pdt on experimental choroidal neovascularization in the monkey. Arch Ophthalmol 2005;123(4):509-16
   PubMed Web of Science ®Google Scholar
• Gaudreault J, Fei D, Rusit J, et al. Preclinical pharmacokinetics of ranibizumab (rhufabv2) after a single intravitreal administration. Invest Ophthalmol Vis Sci 2005;46(2):726-33
   PubMed Web of Science ®Google Scholar
• Chong V. Biological, preclinical and clinical characteristics of inhibitors of vascular endothelial growth factors. Ophthalmologica 2012;227(Suppl 1):2-10
   PubMed Web of Science ®Google Scholar
• Ahn SJ, Ahn J, Park S, et al. Intraocular pharmacokinetics of ranibizumab in vitrectomized versus nonvitrectomized eyes. Invest Ophthalmol Vis Sci 2014;55(1):567-73
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. European public assessment report (EPAR) for Lucentis. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000715/WC500043550.pdf [Last accessed 3 March 2014]
   Google Scholar
• Scott AW, Bressler SB. Long-term follow-up of vascular endothelial growth factor inhibitor therapy for neovascular age-related macular degeneration. Curr Opin Ophthalmol 2013;24(3):190-6
   PubMed Web of Science ®Google Scholar
• Rofagha S, Bhisitkul RB, Boyer DS, Group S-US. Seven-year outcomes in ranibizumab-treated patients in anchor, marina, and horizon: a multicenter cohort study (seven-up). Ophthalmology 2013;120(11):2292-9
   PubMed Web of Science ®Google Scholar
• Rosenfeld PJ, Brown DM, Heier JS, Group MS. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006;355(14):1419-31
   PubMed Web of Science ®Google Scholar
• Brown DM, Kaiser PK, Michels M, Group AS. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006;355(14):1432-44
   PubMed Web of Science ®Google Scholar
• Regillo CD, Brown DM, Abraham P, et al. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: pier study year 1. Am J Ophthalmol 2008;145(2):239-48
   PubMed Web of Science ®Google Scholar
• Lalwani GA, Rosenfeld PJ, Fung AE, et al. A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the pronto study. Am J Ophthalmol 2009;148(1):43-58. e41
   PubMed Web of Science ®Google Scholar
• Brand CS. Management of retinal vascular diseases: a patient-centric approach. Eye (Lond) 2012;26(Suppl 2):S1-16
   PubMedGoogle Scholar
• Bakri SJ, Moshfeghi DM, Francom S, et al. Intraocular pressure in eyes receiving monthly ranibizumab in 2 pivotal age-related macular degeneration clinical trials. Ophthalmology 2014;121(5):1102-8
   PubMed Web of Science ®Google Scholar
• Menke MN, Salam A, Framme C, Wolf S. Long-term intraocular pressure changes in patients with neovascular age-related macular degeneration treated with ranibizumab. Ophthalmologica 2013;229(3):168-72
   PubMed Web of Science ®Google Scholar
• Singer MA, Awh CC, Sadda S, et al. Horizon: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology 2012;119(6):1175-83
   PubMed Web of Science ®Google Scholar
• Silva R, Axer-Siegel R, Eldem B, Group SS. The secure study: long-term safety of ranibizumab 0.5 mg in neovascular age-related macular degeneration. Ophthalmology 2013;120(1):130-9
   PubMed Web of Science ®Google Scholar
• Schmidt-Erfurth U, Eldem B, Guymer R, Group ES. Efficacy and safety of monthly versus quarterly ranibizumab treatment in neovascular age-related macular degeneration: the excite study. Ophthalmology 2011;118(5):831-9
   PubMed Web of Science ®Google Scholar
• Holz FG, Amoaku W, Donate J, Group SS. Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the sustain study. Ophthalmology 2011;118(4):663-71
   PubMed Web of Science ®Google Scholar
• Grunwald JE, Daniel E, Huang J, et al. Risk of geographic atrophy in the comparison of age-related macular degeneration treatments trials. Ophthalmology 2014;121(1):150-61
   PubMed Web of Science ®Google Scholar
• Xu L, Lu T, Tuomi L, et al. Pharmacokinetics of ranibizumab in patients with neovascular age-related macular degeneration: a population approach. Invest Ophthalmol Vis Sci 2013;54(3):1616-24
   PubMed Web of Science ®Google Scholar
• Gaudreault J, Fei D, Beyer JC, et al. Pharmacokinetics and retinal distribution of ranibizumab, a humanized antibody fragment directed against vegf-a, following intravitreal administration in rabbits. Retina 2007;27(9):1260-6
   PubMed Web of Science ®Google Scholar
• Scappaticci FA, Skillings JR, Holden SN, et al. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst 2007;99(16):1232-9
   PubMed Web of Science ®Google Scholar
• Zehetner C, Kirchmair R, Huber S, 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 patients with diabetic macular oedema. Br J Ophthalmol 2013;97(4):454-9
   PubMed Web of Science ®Google Scholar
• Liew G, Mitchell P. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2007;356(7):747-8. author reply 749-750
   PubMed Web of Science ®Google Scholar
• 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. Antiplatelet trialists’ collaboration. BMJ 1994;308(6921):81-106
   PubMed Web of Science ®Google Scholar
• Brown DM, Michels M, Kaiser PK, Group AS. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the anchor study. Ophthalmology 2009;116(1):57-65. e55
   PubMed Web of Science ®Google Scholar
• Abraham P, Yue H, Wilson L. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: pier study year 2. Am J Ophthalmol 2010;150(3):315-24. e311
   PubMed Web of Science ®Google Scholar
• Boyer DS, Heier JS, Brown DM, et al. A phase iiib study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology 2009;116(9):1731-9
   PubMed Web of Science ®Google Scholar
• Comparison of Age-related Macular Degeneration Treatments Trials Research G,roup. Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 2012;119(7):1388-98
   PubMed Web of Science ®Google Scholar
• Busbee BG, Ho AC, Brown DM, Group HS. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology 2013;120(5):1046-56
   PubMed Web of Science ®Google Scholar
• D’Agostino RB, Russell MW, Huse DM, et al. Primary and subsequent coronary risk appraisal: new results from the framingham study. Am Heart J 2000;139(2 Pt 1):272-81
   PubMed Web of Science ®Google Scholar
• Holz FG, Bandello F, Gillies M, et al. 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 2013;97(9):1161-7
   PubMed Web of Science ®Google Scholar
• Campbell RJ, Gill SS, Bronskill SE, et al. Adverse events with intravitreal injection of vascular endothelial growth factor inhibitors: nested case-control study. BMJ 2012;345:e4203
   PubMed Web of Science ®Google Scholar
• Gillies MC, Walton RJ, Arnold JJ, et al. Comparison of outcomes from a phase 3 study of age-related macular degeneration with a matched, observational cohort. Ophthalmology 2014;121(3):676-81
   PubMed Web of Science ®Google Scholar
• Anastasilakis K, Symeonidis C, Kaprinis K, et al. Peripapillary neovascular membrane in a young pregnant woman and prompt response to ranibizumab injections following uneventful delivery. Case Rep Ophthalmol 2011;2(1):129-33
   Google Scholar
• Sullivan L, Kelly SP, Glenn A, et al. Intravitreal bevacizumab injection in unrecognised early pregnancy. Eye (Lond) 2014;28(4):492-4
   PubMed Web of Science ®Google Scholar
• Ehlken C, Martin G, Stahl A, Agostini HT. Reduction of vascular endothelial growth factor a in human breast milk after intravitreal injection of bevacizumab but not ranibizumab. Arch Ophthalmol 2012;130(9):1226-7
   PubMed Web of Science ®Google Scholar
• Castellanos MA, Schwartz S, Garcia-Aguirre G, Quiroz-Mercado H. Short-term outcome after intravitreal ranibizumab injections for the treatment of retinopathy of prematurity. Br J Ophthalmol 2013;97(7):816-19
   PubMed Web of Science ®Google Scholar
• Mintz-Hittner HA, Kennedy KA, Chuang AZ; Group B-RC. Efficacy of intravitreal bevacizumab for stage 3+ retinopathy of prematurity. N Engl J Med 2011;364(7):603-15
   PubMed Web of Science ®Google Scholar
• Mason JO III, Frederick PA, Neimkin MG, et al. Incidence of hemorrhagic complications after intravitreal bevacizumab (avastin) or ranibizumab (lucentis) injections on systemically anticoagulated patients. Retina 2010;30(9):1386-9
   PubMed Web of Science ®Google Scholar
• Moon SW, Oh J, Yu HG, et al. Incidence and risk factors for macular hemorrhage following intravitreal ranibizumab injection for neovascular age-related macular degeneration. J Ocul Pharmacol Ther 2013;29(6):556-9
   PubMed Web of Science ®Google Scholar
• Hayman SR, Leung N, Grande JP, Garovic VD. Vegf inhibition, hypertension, and renal toxicity. Curr Oncol Rep 2012;14(4):285-94
   PubMed Web of Science ®Google Scholar
• Pelle G, Shweke N, Duong Van Huyen JP, et al. Systemic and kidney toxicity of intraocular administration of vascular endothelial growth factor inhibitors. Am J Kidney Dis 2011;57(5):756-9
   PubMed Web of Science ®Google Scholar
• Curtis LH, Hammill BG, Schulman KA, Cousins SW. Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration. Arch Ophthalmol 2010;128(10):1273-9
   PubMed Web of Science ®Google Scholar
• Group CR. Martin DF, Maguire MG, Ying GS, et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 2011;364(20):1897-908
   PubMed Web of Science ®Google Scholar
• Investigators IS, Chakravarthy U, Harding SP, et al. Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the ivan randomized trial. Ophthalmology 2012;119(7):1399-411
   PubMedGoogle Scholar
• Chakravarthy U, Harding SP, Rogers CA, investigators Is. Alternative treatments to inhibit vegf in age-related choroidal neovascularisation: 2-year findings of the ivan randomised controlled trial. Lancet 2013;382(9900):1258-67
   PubMed Web of Science ®Google Scholar
• Cheung CM, Wong TY. Treatment of age-related macular degeneration. Lancet 2013;382(9900):1230-2
   PubMed Web of Science ®Google Scholar
• Schmucker C, Ehlken C, Agostini HT, et al. A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard. PLoS One 2012;7(8):e42701
   PubMed Web of Science ®Google Scholar
• Administration FaD. Highlights of prescribing information, lucentis (genentech). 2006. Available from: www.Accessdata.Fda.Gov/drugsatfda_docs/label/2006/125156lbl.Pdfvia [Last accessed 29 October 2013]
   Google Scholar
• Epar for eylea. 2012. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002392/WC500135815.pdf
   Google Scholar
• Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (vegf trap-eye) in wet age-related macular degeneration. Ophthalmology 2012;119(12):2537-48
   PubMed Web of Science ®Google Scholar
• Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, et al. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the view studies. Ophthalmology 2014;121(1):193-201
   PubMed Web of Science ®Google Scholar
• Beaumont PE, Petocz P, Kang HK. Is there risk of stroke with aflibercept? Ophthalmology 2014;121(1):e4
   PubMed Web of Science ®Google Scholar
• Ueta T. Safety in aflibercept versus ranibizumab. Ophthalmology 2014;121(1):e5
   PubMedGoogle Scholar
• Heier JS, Brown DM, Chong V, et al. Author reply: to pmid 23084240. Ophthalmology 2014;121(1):e5-6
   PubMedGoogle Scholar
• Heier JS, Boyer DS, Ciulla TA, Group FS. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration: year 1 results of the focus study. Arch Ophthalmol 2006;124(11):1532-42
   PubMed Web of Science ®Google Scholar
• Jackson TL, Chakravarthy U, Kaiser PK, Group IS. Stereotactic radiotherapy for neovascular age-related macular degeneration: 52-week safety and efficacy results of the intrepid study. Ophthalmology 2013;120(9):1893-900
   PubMed Web of Science ®Google Scholar
• Kaiser RS. Anti-pdgf combination therapy for AMD. Results of a phase 2 study. Retina Today 2013;68-70
   Google Scholar
• Tan JS, Wang JJ, Liew G, et al. Age-related macular degeneration and mortality from cardiovascular disease or stroke. Br J Ophthalmol 2008;92(4):509-12
   PubMed Web of Science ®Google Scholar
• Sulzbacher F, Kiss C, Kaider A, et al. Correlation of oct characteristics and retinal sensitivity in neovascular age-related macular degeneration in the course of monthly ranibizumab treatment. Invest Ophthalmol Vis Sci 2013;54(2):1310-15
   PubMed Web of Science ®Google Scholar
• Chang AA, Li H, Broadhead GK, et al. Intravitreal aflibercept for treatment-resistant neovascular age-related macular degeneration. Ophthalmology 2014;121(1):188-92
   PubMed Web of Science ®Google Scholar
• Lanzetta P, Holz F, Mones J, et al. Intravitreal injections: a healthcare failure modes and effects analysis. Ophthalmologica 2013;230(3):151-64
   PubMed Web of Science ®Google Scholar
• Goldberg RA, Flynn HW Jr, Isom RF, et al. An outbreak of streptococcus endophthalmitis after intravitreal injection of bevacizumab. Am J Ophthalmol 2012;153(2):204-8. e201
   PubMed Web of Science ®Google Scholar