Офтальмохирургия. 2020; : 86-92
Раннее переключение с антивазопролиферативной терапии на имплант дексаметазона у пациентов при диабетическом макулярном отеке
https://doi.org/10.25276/0235-4160-2020-4-86-92Аннотация
Диабетическая ретинопатия (ДР) является грозным осложнением течения сахарного диабета, ассоциированным с развитием диабетического макулярного отека (ДМО) и, как следствие, снижением остроты зрения. Основные патогенетические факторы развития ДМО – это воспаление и активация синтеза фактора роста сосудов (Vascular endothelial growth factor – VEGF). Подходы к лечению ДМО постоянно меняются. Известно, что значимого клинического результата при применении антивазопролиферативной терапии удается достигнуть отнюдь не у всех пациентов. Отсутствие или минимальный эффект от проводимого лечения наблюдается у пациентов с персистирующим течением ДМО, что привело к острой необходимости разработки новых протоколов лечения данной группы пациентов. В этом случае добавление интравитреального введения кортикостероидов в схему лечения может быть более эффективным и предсказуемым, чем монотерапия антивазопролиферативными препаратами. Согласно данным международных многоцентровых рандомизированных исследований, у пациентов, которые были переведены с антивазопро- лиферативной терапии на имплантат c дексаметатазоном, наблюдалось статистически достоверное улучшение как функциональных, так и анатомических параметров, что натолкнуло исследователей на мысль об эффективности комбинированного подхода к лечению данной группы пациентов. Важным вопросом также являются эффективность и безопасность интравитреального использования кортикостероидов в качестве терапии первой линии, а также определение четких показаний к их применению. Эти данные позволят определить роль раннего переключения пациентов с ДМО на интравитреальное введение имплантата дексаметазона в аспекте существующего на сегодняшний день алгоритма лечения. Задачей научного сообщества остается разработка оптимальных протоколов комбинированного подхода в лечении пациентов с ДМО, а также поиск критериев и сроков переключения пациентов с антивазопролиферативной терапии на интравитреальное введение имплантата дексаметазона в комплексе с лазерной коагуляцией сетчатки при необходимости.
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40. Gillies MC, Lim LL, Campain A. A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: The BEVORDEX study. Ophthalmology. 2014;121(12):2473–2481. doi: 10.1016/j.ophtha.2014.07.002
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Fyodorov Journal of Ophthalmic Surgery. 2020; : 86-92
Early switch from anti-VEGF Therapy to dexamethasone implant in diabetic macular edema
https://doi.org/10.25276/0235-4160-2020-4-86-92Abstract
Diabetic retinopathy (DR) is the one of severe complications of diabetes, associated with macular edema (DME), which is the main course of visual acuity loss in diabetic patients. The main pathological factors in diabetic retinopathy and diabetic macular edema (DME) are the inflammation and increasing of vascular endothelium growth factor activity (VEGF). The treatment of DME remains challenging during the times. We know that not all eyes respond optimally to anti-VEGF therapy. No clinical effect or minimal one among patients with persistent DME has led to an urgent need to develop new treatment protocols for this group of patients. In this case adding intravitreal corticosteroids to the treatment regimen is the most effective and predictаble than continued anti-VEGF therapy alone. According to results of randomized trials the functional and anatomical outcomes in eyes with refractory DME, which were switched to DEX implant had shown statistically significant better outcome, compared to anti-VEGF therapy alone. Another important question is efficiency and safety of using intravitreal corticosteroids as the first-line therapy in patients with DME. These new findings can help to define better the role of early switch to DEX implant in the current treatment algorithm of eyes with refractory DME. And find the optimal protocol of treatment patients with DME, determine the predictors of switching from anti-VEGF therapy to steroid intravitreal injections, in DME should be on the agenda of the future studies.
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8. Mitchell P, Bandello F, Schmidt-Erfurth U. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118(4): 615–625. doi: 10.1016/j.ophtha.2011.01.031
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20. Heier JS, Korobelnik JF, Brown DM. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016;123(11): 2376–2385. doi: 10.1016/j.ophtha.2016.07.032
21. Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab or ranibizumab for diabetic macular edema. New Engl J Med. 2015;372(13): 1193–1203.
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24. Bressler NM, Beaulieu WT, Glassman AR, Blinder KJ, Bressler SB, Jampol LM, Melia M, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Persistent macular thickening following intravitreous aflibercept, bevacizumab, or ranibizumab for central-involved diabetic macular edema with vision impairment: A secondary analysis of a randomized clinical trial. JAMA Ophthalmol. 2018;136: 257–269.
25. Gonzalez VH, Campbell J, Holekamp NM, et al. Early and long-term responses to anti-vascular endothelial growth factor therapy in diabetic macular edema: analysis of protocol I data. Am J Ophthalmol. 2016;172(12): 72–79. doi: 10.1016/j.ajo.2016.09.012
26. Keane PA, Liakopoulos S, Ongchin SC. Quantitative subanalysis of optical coherence toography after treatment with ranibizumab for neovascular agerelated macular degeneration. Invest Ophthalmol Vis Sci. 2008;49(7): 3115–3120. doi: 10.1167/iovs.08-1689
27. Almony A, Mansouri A, Shah GK, Blinder KJ. Efficacy of intravitreal bevacizumab after unresponsive treatment with intravitreal ranibizumab. Can J Ophthalmol. 2011;46(2): 182C185. doi: 10.3129/i10-095
28. Arjamaa O, Minn H. Resistance, not tachyphylaxis or tolerance. Br J Ophthalmol. 2012;96(8):1153–1154. doi: 10.2147/DDDT.S97653
29. Bobykin E.V., Korotkikh S.A., Buslaev R.V. Kratkosrochnye rezul'taty pereklyucheniya («switching») i vozvrashcheniya («switch back») antiangiogennykh preparatov v lechenii neovaskulyarnoi vozrastnoi makulyarnoi degeneratsii. Otrazhenie. 2018;1(6): 55–60. Dostupno po: https://eyepress.ru/sbornik.aspx?813 [Ssylka aktivna na 11.11.2020]. Bobykin EV, Korotkih SA, Buslaev RV. Kratkosrochnye rezul’taty pereklyucheniya («switching») i vozvrashcheniya («switch back») antiangiogennyh preparatov v lechenii neovaskulyarnoj vozrastnoj makulyarnoj degeneracii. Otrazhenie. 2018;1(6): 55–60. Dostupno po: https://eyepress.ru/sbornik.aspx?813 [Ssylka aktivna na 11.11.2020]
30. Gaudreault J, Fei D, Beyer JC. Pharmacokinetics and retinal distribution of ranibizumab, a humanized antibody fragment directed against VEGF-A, following intravitreal administration in rabbits. Retina. 2007;27(9):1260–1266. doi: 10.1097/IAE.0b013e318134eecd
31. Gardner TW, Jose RD. The neurovascular unit and the pathophysiologic basis of diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2016;255: 1–6.
32. Adamis AP, Berman AJ. Immunological mechanisms in the pathogenesis of diabetic retinopathy. 2008;30(2): 65–84. Seminars in Immunopathology. doi: 10.1007/s00281-008-0111-x
33. Medeiros M, Postorino M, Navarro R, Garcia- Arumi J. Dexamethazone intravitreal implant for treatment of patients with persistent diabetic macular edema. Ophthalmologica. 2013; 231(3): 141–146. doi: 10.1159/000356413
34. Instruktsiya po meditsinskomu primeneniyu lekarstvennogo preparata «Ozudeks». Dostupno po: https://grls.rosminzdrav.ru/
35. Kodjikian L. Pharmacological management of diabetic macular edema in real-life observational studies. Biomed Res Int. 2018;28(8): 8289253. doi: 10.1155/2018/8289253
36. Malclès A, Dot C, Voirin N, Agard É, Vié A-L, Bellocq D, Denis P, Kodjikian L. Real-life study in diabetic macular edema treated with dexamethasone implant: The RELDEX study. Retina. 2017;37(4): 753–760. doi: 10.1097/IAE.0000000000001234
37. Pacella F, Romano MR, Turchetti P. An eighteenmonth follow-up study on the effects of intravitreal dexamethasone implant in diabetic macular edema refractory to anti-VEGF therapy. Int J Ophthalmol. 2016; 9(10): 1427–1432. doi: 10.18240/ijo.2016.10.10
38. Martínez A, Pereira Delgado E, Silva Silva G, et al. Early versus late switch: how long should we extend the anti-vascular endothelial growth factor therapy in unresponsive diabetic macular edema patients? Eur J Ophthalmol. 2020; 30(5): 1091–1098. doi: 10.1177/1120672119848257
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