Pharmacokinetics of intravitreal anti-VEGF drugs in vitrectomized versus non-vitrectomized eyes

References

• Gupta N, Mansoor S, Sharma A, et al. Diabetic retinopathy and VEGF. Open Ophthalmol J. 2013;7:4–9.
   PubMedGoogle Scholar
• Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age related macular degeneration. N Engl J Med. 2006;355:1419–1431.
   PubMed Web of Science ®Google Scholar
• Campochiaro PA, Heier JS, Feiner L, et al. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117:1102–1112.
   PubMed Web of Science ®Google Scholar
• The CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011;364:1897–1908.
   PubMed Web of Science ®Google Scholar
• Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247–2254.
   PubMed Web of Science ®Google Scholar
• Amoaku WM, Chakravarthy U, Gale R, et al. Defining response to anti-VEGF therapies in neovascular AMD. Eye (Lond). 2015;29(6):721–731.
   PubMed Web of Science ®Google Scholar
• Krohne TU, Muether PS, Stratman NK, et al. Influence of ocular volume and lens status on pharmacokinetics and duration of action of intravitreal vascular endothelial growth factor inhibitors. Retina. 2015;35:69–74.
   PubMed Web of Science ®Google Scholar
• Gisladottir S, Loftsson T, Stefansson E. Diffusion characteristics of vitreous humour and saline solution follow the Stokes Einstein equation. Graefes Arch Clin Exp Ophthalmol. 2009;247:1677–1684.
   PubMed Web of Science ®Google Scholar
• Mains J, Wilson CG. The vitreous humor as a barrier to nanoparticle distribution. J Ocul Pharmacol Ther. 2013;29(2):143–150.
   PubMed Web of Science ®Google Scholar
• Awwad S, Lockwood A, Brocchini S, et al. The PK-eye: a novel in vitro ocular flow model for use in preclinical drug development. J Pharm Sci. 2015;104:3330–3342.
   PubMed Web of Science ®Google Scholar
• Stefánsson E. Physiology of vitreous surgery. Graefe’s Archive Clin Exp Ophthalmol. 2009;247(2):147–163.
   PubMed Web of Science ®Google Scholar
• Chin HS, Park TS, Moon YS, et al. Difference in clearance of intravitreal triamcinolone acetonide between vitrectomized and nonvitrectomized eyes. Retina. 2005;25:556–560.
   PubMed Web of Science ®Google Scholar
• Jarus G, Blumenkranz M, Hernandez E, et al. Clearance of intravitreal fluorouracil. Normal and aphakic vitrectomized eyes. Ophthalmology. 1985;92:91–96.
   PubMed Web of Science ®Google Scholar
• Macugen, INN-pegaptanib sodium. Summary of product characteristics. Accessed Sept 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR-Product_Information/human/000620/WC500026214.pdf
   Google Scholar
• Foy JW, Rittenhouse K, Modi M, et al. Local tolerance and systemic safety of pegaptanib sodium in the dog and rabbit. J Ocul Pharmacol Ther. 2007;23(5):452–466.
   PubMed Web of Science ®Google Scholar
• Drolet DW, Nelson J, Tucker CE, et al. Pharmacokinetics and safety of an anti-vascular endothelial growth factor aptamer (NX1838) following injection into the vitreous humor of rhesus monkeys. Pharm Res. 2000;17(12):1503–1510.
   PubMed Web of Science ®Google Scholar
• Kourlas H, Schiller DS. Pegaptanib sodium for the treatment of neovascular age-related macular degeneration: a review. Clin Ther. 2006;26:36–44.
   Google Scholar
• Keane PA, Sadda SR. Development of anti-VEGF therapies for intraocular use: a guide for clinicians. J Ophthalmol. 2012;2012:483034.
   PubMed Web of Science ®Google Scholar
• Apte RS, Modi M, Masonson H, et al. Pegaptanib 1-year systemic safety results from a safety-pharmacokinetic trial in patients with neovascular age-related macular degeneration. Ophthalmology. 2007;114(9):1702–1712.
   PubMed Web of Science ®Google Scholar
• Singerman LJ, Masonson H, Patel M, et al. Pegaptanib sodium for neovascular age-related macular degeneration: third-year safety results of the VEGF inhibition study in ocular neovascularisation (VISION) trial. Br J Ophthalmol. 2008;92(12):1606–1611.
   PubMed Web of Science ®Google Scholar
• Gragoudas ES, Adamis AP, Cunningham ET Jr., et al. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004;351(27):2805–2816.
   PubMed Web of Science ®Google Scholar
• Sultan MB, Zhou D, Loftus J, et al. A phase 2/3, multicenter, randomized, double-masked, 2-year trial of pegaptanib sodium for the treatment of diabetic macular edema. Ophthalmology. 2011;118(6):1107–1118.
   PubMed Web of Science ®Google Scholar
• Kiire CA, Morjaria M, Rudenko A, et al. Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema. Clin Ophthalmol. 2015;9:2305–2311.
   PubMed Web of Science ®Google Scholar
• Patel M, Whitfield L, Hutmacher M, et al. Population pharmacokinetics/pharmacodynamics (PK/PD) of Pegaptanib Sodium (Macugen®) in patients with age–related macular degeneration (AMD). Iovs. 2006;47:2623.
   PubMedGoogle Scholar
• Basile AS, Hutmacher MM, Kowalski KG, et al. Population pharmacokinetics of pegaptanib sodium (Macugen®) in patients with diabetic macular edema. Clin Ophthalmol. 2015;9:323–335.
   PubMed Web of Science ®Google Scholar
• Christoforidis JB, Williams MM, Wang J, et al. Anatomic and pharmacokinetic properties of intravitreal bevacizumab and ranibizumab after vitrectomy and lensectomy. Retina. 2013;33:946–952.
   PubMed Web of Science ®Google Scholar
• Bakri SJ, Snyder MR, Reid JM, et al. Pharmacokinetics of intravitreal bevacizumab (Avastin). Ophthalmology. 2007;114:855–859.
   PubMed Web of Science ®Google Scholar
• Nomoto H, Shiraga F, Kuno N, et al. Pharmacokinetics of bevacizumab after topical, subconjunctival, and intravitreal administration in rabbits. Invest Ophthal Vis Sci. 2009;50:4807–4813.
   PubMed Web of Science ®Google Scholar
• Sinapis CI, Routsias JG, Sinapis AI, et al. Pharmacokinetics of intravitreal bevacizumab (Avastin) in rabbits. Clin Ophthalmol. 2001;5:697–704.
   Google Scholar
• Ahn J, Kim H, Woo SJ, et al. Pharmacokinetics of intravitreally injected bevacizumab in vitrectomized eyes. J Ocul Pharmacol Ther. 2013;29:612–618.
   PubMed Web of Science ®Google Scholar
• Goldenberg DT, Giblin FJ, Cheng M, et al. Posterior vitreous detachment with microplasmin alters the retinal penetration of intravitreal bevacizumab (Avastin) in rabbit eyes. Retina. 2011;31:393–400.
   PubMed Web of Science ®Google Scholar
• Miyake T, Sawada O, Kakinoki M, et al. Pharmacokinetics of bevacizumab and its effect on vascular endothelial growth factor after intravitreal injection in macaque eyes. Invest Ophthalmol Vis Sci. 2010;51:1606–1608.
   PubMed Web of Science ®Google Scholar
• Kakinoki M, Sawada O, Sawada T, et al. Effect of vitrectomy on aqueous VEGF concentration and pharmacokinetics of bevacizumab in macaque monkeys. Invest Ophthalmol Vis Sci. 2012;53:5877–5880.
   PubMed Web of Science ®Google Scholar
• Yanyali A, Aytug B, Horozoglu F, et al. Bevacizumab (Avastin) for diabetic macular edema in previously vitrectomized eyes. Am J Ophthalmol. 2007;144:124–126.
   PubMed Web of Science ®Google Scholar
• Mehta S, Blinder KJ, Shah GK, et al. Intravitreal bevacizumab for the treatment of refractory diabetic macular edema. Ophthalmic Surg Lasers Imaging. 2010;41:323–329.
   PubMedGoogle Scholar
• Moisseiev E, Waisbourd M, Ben-Artsi E, et al. Pharmacokinetics of bevacizumab after topical and intravitreal administration in human eyes. Arch Clin Exp Ophthalmol. 2014;252:331–337.
   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):726–733.
   PubMed Web of Science ®Google Scholar
• Stewart MW. What are the half-lives of ranibizumab and aflibercept (Trap-eye VEGF) in human eyes? Calculations with a mathematical model. Eye Reports. 2011;1:5.
   Google Scholar
• Schindler RH, Chandler D, Thresher R, et al. The clearance of intravitreal triamcinolone acetonide. Am J Ophthalmol. 1982;93(4):415–417.
   PubMed Web of Science ®Google Scholar
• Doft BH, Weiskopf J, Nilsson-Ehle I, et al. Amphotericin clearance in vitrectomized versus non-vitrectomized eyes. Ophthalmology. 1985;92:1601–1605.
   PubMed Web of Science ®Google Scholar
• Pearson PA, Hainsworth DP, Ashton P. Clearance and distribution of ciprofloxacin after intravitreal injection. Retina. 1993;13(4):326–330.
   PubMed Web of Science ®Google Scholar
• Mandell BA, Meredith TA, Aguilar E, et al. Effects of inflammation and surgery on amikacin levels in the vitreous cavity. Am J Ophthalmol. 1993;115(6):770–774.
   PubMed Web of Science ®Google Scholar
• Aguilar HE, Meredith TA, el-Massry A, et al. Vancomycin levels after intravitreal injection. Effects of inflammation and surgery. Retina. 1995;15(5):428–432.
   PubMed Web of Science ®Google Scholar
• Shaarawy A, Meredith TA, Kincaid M, et al. Intraocular injection of ceftazidime. Effects of inflammation and surgery. Retina. 1995;15(5):433–438.
   PubMed Web of Science ®Google Scholar
• Pflugfelder SC, Hernández E, Fliesler SJ, et al. Intravitreal vancomycin. Retinal toxicity, clearance, and interaction with gentamicin. Arch Ophthalmol. 1987;105(6):831–837.
   PubMedGoogle Scholar
• Ahn SJ, Ahn J, Park S, et al. Intraocular pharmacokinetics of ranibizumab in vitrectomized versus nonvitrectomized eyes. Invest Ophthalmol Vis Sci. 2014;55:567–573.
   PubMed Web of Science ®Google Scholar
• Niwa Y, Kakinoki M, Sawada T, et al. Ranibizumab and aflibercept: intraocular pharmacokinetics and their effects on aqueous VEGF level in vitrectomized and nonvitrectomized macaque eyes. Invest Ophthalmol Vis Sci. 2015;56(11):6501–6505.
   PubMed Web of Science ®Google Scholar
• Laugesen CS, Ostri C, Brynskov T, et al. Intravitrealranibizumab for diabetic macular oedema in previously vitrectomized eyes. Acta Ophthalmol. 2017;95(1):28–32.
   PubMed Web of Science ®Google Scholar
• Koyanagi Y, Yoshida S, Kobayashi Y, et al. Comparison of the effectiveness of intravitreal ranibizumab for diabetic macular edema in vitrectomized and nonvitrectomized eyes. Ophthalmologica. 2016;236(2):67–73.
   PubMed Web of Science ®Google Scholar
• Bressler SB, Melia M, Glassman AR, et al. Diabetic retinopathy clinical research network. Ranibizumab plus prompt or deferred laser for diabetic macular edema in eyes with vitrectomy before anti-vascular endothelial growth factory therapy. Retina. 2015;35(12):2516–2528.
   PubMed Web of Science ®Google Scholar
• Chen YY, Chen PY, Chen FT, et al. Comparison of efficacy of intravitreal ranibizumab between non-vitrectomized and vitrectomized eyes with diabetic macular edema. Int Ophthalmol. 2017 Feb 7. [Epub ahead of print]. Available from: https://doi.org/10.1007/s10792-017-0462-1
   Google Scholar
• Stewart MW, Rosenfeld PJ. Predicted biological activity of intravitreal VEGF Trap. Br J Ophthalmol. 2008;92:667–668.
   PubMed Web of Science ®Google Scholar
• Klettner A, Recber M, Roider J. Comparison of the efficacy of aflibercept, ranibizumab, and bevacizumab in an RPE/choroid organ culture. Graefes Arch Clin Exp Ophthalmol. 2014;252:1593–1598.
   PubMed Web of Science ®Google Scholar
• Papadopoulos N, Martin J, Ruan Q, et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis. 2012;15:171–185.
   PubMed Web of Science ®Google Scholar
• Christoforidis JB, Williams MM, Kothandaraman S, et al. Pharmacokinetic properties of intravitreal I-124-aflibercept in a rabbit model using PET/CT. Curr Eye Res. 2012;37:1171–1174.
   PubMed Web of Science ®Google Scholar
• Park SJ, Oh J, Kim Y-K, et al. Intraocular pharmacokinetics of intravitreal vascular endothelial growth factor-Trap in a rabbit model. Eye. 2015;29:561–568.
   PubMed Web of Science ®Google Scholar
• Park SJ, Choi Y, Mi Na Y, et al. Intraocular pharmacokinetics of intravitreal aflibercept (Eylea) in a rabbit model. Invest Ophthalmol Vis Sci. 2016;57:2612–2617.
   PubMed Web of Science ®Google Scholar
• Regeneron Pharmaceuticals, Inc. Eylea (aflibercept) injection prescribing information. Tarrytown, NY; 2015 Jul. Accessed 2017 Jul. https://www.regeneron.com/sites/default/files/EYLEA_FPI.pdf
   Google Scholar
• Wells JA, Glassman AR, Ayala AR, et al. The Diabetic Retinopathy Clinical Research Network. Aflibercept, Bevacizumab, or Ranibizumab for diabetic macular edema. N Engl J Med. 2015;372:1193–1203.
   PubMed Web of Science ®Google Scholar
• Fouda SM, Bahgat AM. Intravitreal aflibercept versus intravitreal ranibizumab for the treatment of diabetic macular edema. Clin Ophthalmol. 2017;11:567–571.
   PubMed Web of Science ®Google Scholar
• Grewal DS, Gill MK, Sarezky D, et al. Visual and anatomical outcomes following intravitreal aflibercept in eyes with recalcitrant neovascular age-related macular degeneration: 12 month results. Eye (Lond). 2014;28(7):895–899.
   PubMed Web of Science ®Google Scholar
• Hahn P. Successful treatment of neovascular age-related macular degeneration following single bevacizumab failure using aflibercept in a vitrectomised eye. Clin Ophthalmol. 2014;8:2129–2131.
   PubMedGoogle Scholar
• Rahimy E, Shahlaee A, Khan MA, et al. Conversion to aflibercept after prior anti-VEGF therapy for persistent diabetic macular edema. Am J Ophthalmol. 2016;164:118–127.
   PubMed Web of Science ®Google Scholar
• Wood EH, Karth PA, Moshfeghi DM, et al. Short-term outcomes of aflibercept therapy for diabetic macular edema in patients with incomplete response to ranibizumab and/or bevacizumab. Ophthalmic Surg Lasers Imaging Retina. 2015;46:950–954.
   PubMed Web of Science ®Google Scholar
• Lim LS, Ng WY, Mathur R, et al. Conversion to aflibercept for diabetic macular edema unresponsive to ranibizumab or bevacizumab. Clin Ophthalmol. 2015;9:1715–1718.
   PubMed Web of Science ®Google Scholar
• Chen YY, Chang PY, Wang JK. Intravitreal aflibercept for patients with diabetic macular edema refractory to bevacizumab or ranibizumab: analysis of response to aflibercept. Asia Pac J Ophthalmol (Phila). 2017;6(3):250–255.
   PubMed Web of Science ®Google Scholar
• Jung JJ, Hoang QV, Yameen Arain MZ, et al. Aflibercept anti-vascular endothelial growth factor therapy in vitrectomized eyes with neovascular age-related macular degeneration. Acta Ophthalmol. 2016;94(3):e249–e250.
   PubMed Web of Science ®Google Scholar
• Avery RL, Castellarin AA, Steinlle NC, et al. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014;98(12):1636–1641.
   PubMed Web of Science ®Google Scholar
• Avery RL, Castellarin AA, Steinlle NC, et al. Systemic pharmacokinetics and pharmacodynamics of intravitreal aflibercept, bevacizumab, and ranibizumab. Retina. 2017;37(10):1847–1858.
   Web of Science ®Google Scholar
• Del Amo EM, Urtti A. Rabbit as an animal model for intravitreal pharmacokinetics: clinical predictability and quality of the published data. Exp Eye Res. 2015;137:111–124.
   PubMed Web of Science ®Google Scholar
• Thassu D, Chader GJ. editor. Ocular drug delivery systems: barriers and applications of nanoparticulate systems. Chapter 8. Boca Raton: CRC Press. 2013. 161–162.
   Google Scholar
• Campochiaro PA, Channa R, Berger BB, et al. Treatment of diabetic macular edema with a designed ankyrin repeat protein that binds vascular endothelial growth factor. Am J Ophthalmol. 2013;155(4):697–704.
   PubMed Web of Science ®Google Scholar
• Boyer DS, Faber D, Gupta S, et al. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011;31(5):915–923.
   PubMed Web of Science ®Google Scholar
• Reibaldi M, Russo A, Zagari M, et al. Resolution of persistent cystoid macular edema due to central retinal vein occlusion in a vitrectomized eye following intravitreal implant of dexamethasone 0.7mg. Case Rep Ophthalmol. 2012;3(1):30–34.
   PubMedGoogle Scholar
• Adan A, Pelegrin L, Rey A, et al. Dexamethasone intravitreal implant for treatment of uveitic persistent cystoid macular edema in vitrectomized patients. Retina. 2013;33(7):1435–1440.
   PubMed Web of Science ®Google Scholar