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Офтальмохирургия. 2019; : 67-76

Современные подходы к лечению диабетического макулярного отёка

Бобыкин Е. В.

https://doi.org/10.25276/0235-4160-2019-1-67-76

Аннотация

Несмотря на безусловные достижения в области лечения глазных проявлений сахарного диабета, диабетический макулярный отёк (ДМО) остаётся распространённой причиной потери зрения. До недавнего времени лечение ДМО основывалось на сочетании тщательного метаболического контроля и применения лазерной коагуляции. Такой подход способствовал стабилизации, но не улучшению зрительных функций. При этом лазерная коагуляция, несмотря на эффективность, рассматривается как деструктивный по форме и сопряженный с побочными эффектами вид лечения. Ограниченные возможности терапии диабетической ретинопатии обусловили активное изучение препаратов, способных включаться в сложные патогенетические механизмы развития и прогрессирования данного заболевания. Современный мировой опыт лечения позволяет констатировать сдвиг па
радигмы в лечении ДМО: на первую роль выдвинулась антиангиогенная терапия (интравитреальные инъекции ингибиторов VEGF-сосудистого эндотелиального фактора роста), эффективность и безопасность которой позволили ей отодвинуть на второй план лазерную коагуляцию сетчатки, терапию стероидами и витреоретинальную хирургию. В статье рассмотрена современная доказательная база применения при ДМО анти-VEGF-терапии, лазерного лечения и интравитреальных стероидов. Приводятся данные о сравнительной эффективности и возможности совместного применения различных методов лечения, а также сопоставляются основные антиангиогенные средства и режимы их применения.
Список литературы

1. Ciulla T.A., Amador A.G., Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies. Diabetes Care.2003;26(9); 2653-2664. Available from: https://doi.org/10.2337/diacare.26.9.2653.

2. Davis M.D., Fisher M.R., Gangnon R.E. et al. Risk factors for high-risk proliferative diabetic retinopathy and severe visual loss: Early Treatment Diabetic Retinopathy Study report number 18. Invest. Ophthalmol. Vis. Sci. 1998;39: 233-252.

3. Zaynullina S.A., Fayzrakhmanov R.R., Yarmukhametova A.L. Diabetic macular edema, clinical manifestations, diagnostic (literature review). Vostok- Zapad; 2012: р.275. (In Russ.).

4. Funatsu H., Noma H., Mimura T. et al. Association of vitreous inflammatory factors with diabetic macular edema. Ophthalmology. 2009;116(1): 73¬79. Available from: https://doi.org/10.1016/j.ophtha. 2008.09.037.

5. Coyne K.S., Margolis M.K., Kennedy-Martin T. et al. The impact of diabetic retinopathy: perspectives from patient focus groups. Fam. Pract. 2004. 21(4); 447-453.

6. American Diabetes Association. Screening for diabetic retinopathy. Diabetes Care. 1997;20: 28-30.

7. Shadrichev F.E. Diabetic Retinopathy (ophthalmologist view). Sakharnyi diabet. 2008;3: 8-11(In Russ.).

8. Singh R., Ramasamy K., Abraham C. et al. Diabetic retinopathy: An update. Indian J. Ophthalmol. 2008;56(3): 179-188.

9. Shaya F.T., Aljawadi M. Diabetic retinopathy Clin Ophthalmol. 2007;1(3); 259-265.

10. Distefano L.N., Garcia-Arumi J., Martinez- Castillo V. et al. Combination of Anti-VEGF and Laser Photocoagulation for Diabetic Macular Edema: A Review. J. Ophthalmol. 2017:2407037. Available from: https:// doi.org/10.1155/2017/2407037.

11. Wong T.Y., Mwamburi M., Klein R. et al. Rates of progression in diabetic retinopathy during different time periods: a systematic review and meta-analysis. Diabetes Care. 2009;32(12): 2307-2313.

12. Au A., Singh R.P A multimodal approach to diabetic macular edema. J. Diabetes Complicat. 2016;30: 545-553. Available from: https://doi.org/10.1016/). jdiacomp.2015.11.008.

13. Demidova T.Y., Trakhtenberg Y.A. Current approaches to the management of diabetic retinopathy. Diabetes mellitus. 2014;17(3):122-128. (in Russ.). Available from: https://doi.org/10.14341/DM20143122-128.

14. Okhocymskaya T.D., Zayceva O.V. Aflibercept in treatment of retinal diseases. Clinical studies review. Rossiiskii oftal’mologicheskii zhurnal. 2017;10(2): 103-111. (In Russ.). Available from: https://doi.org/10.21516/2072-0076-2017-10- 2-103-111.

15. Schmidt-Erfurth U., Garcia-Arumi J., Bandello F. et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2017;237(4): 185-222. Available from: https://doi.org/10.1159/000458539.

16. Early Treatment Diabetic Retinopathy Study Research Group. Techniques for scatter and local photocoagulation treatment of diabetic retinopathy: early treatment diabetic retinopathy study report number 3. International Ophthalmology Clinics. 1987:27(4); 254-264.

17. Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch. Ophthalmol. 1985:103(12); 1796-1806.

18. Luttrull J.K., Dorin G. Subthreshold diode micropulse laser photocoagulation (SDM) as invisible retinal phototherapy for diabetic macular edema: a review. Curr. Diabetes Rev. 2012;8(4): 274-284. Available from: https://doi.org/10.2174/157339912800840523.

19. Schatz H., Madeira D., McDonald H.R. et al. Progressive enlargement of laser scars following grid laser photocoagulation for diffuse diabetic macular edema. Arch. Ophthalmol. 1991;109(11): 1549-1551.

20. Fong D.S., Strauber S.F. et al. Comparison of the modified Early Treatment Diabetic Retinopathy Study and mild macular grid laser photocoagulation strategies for diabetic macular edema. Archives Arch. Ophthalmol. 2007:125(4); 469-480. Available from: https://doi. org/10.1001/archopht.125.4.469.

21. Boyer D.S., Yoon Y.H., Belfort Jr.R. et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014:121(10): 1904-1914. Available from: https://doi.org/10.1016/j. ophtha.2014.04.024.

22. He Y., Ren X.J., Hu B.J. et al. A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema. BMC Ophthalmology. 2018;18(1): 121. Available from: https:// doi.org/10.1186/s12886-018-0779-1.

23. Busch C., Zur D., Fraser-Bell S. et al. Shall we stay, or shall we switch? Continued anti-VEGF therapy versus early switch to dexamethasone implant in refractory diabetic macular edema. Acta diabetologica. 2018:55(8); 789-796. Available from: https://doi.org/10.1007/ s00592-018-1151-x.

24. Iglicki M., Busch C., Zur D. et al. Dexamethasone implant for diabetic macular edema in naive compared with refractory eyes: The International Retina Group Real-Life 24-Month Multicenter Study. The IRGREL-DEX Study. Retina. 2019;39(1): 44-51. Available from: https:// doi.org/10.1097/IAE.0000000000002196.

25. Maturi R.K., Glassman A.R., Liu D. et al. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018;136(1): 29-38. Available from: https://doi.org/10.1001/ jamaophthalmol.2017.4914.

26. Kodjikian L., Decullier E., Souied E.H. et al. Bevacizumab and ranibizumab for neovascular age- related macular degeneration: an updated meta-analysis of randomised clinical trials. Graefe’s Arch. Clin. Exp. Ophthalmol. 2014;252(10): 1529-1537. Available from: https://doi.org/10.1007/s00417-014-2764-6.

27. 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(2): 171-185. Available from: https://doi.org/10.1007/s10456-011- 9249-6.

28. Diabetic Retinopathy Clinical Research Network, Elman M. J., Aiello L. P., et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010;117(6): 1064- 1077.e35. Available from: https://doi.org/10.1016/j. ophtha.2010.02.031.

29. Elman M.J., Bressler N.M., Qin H. et al. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011;118(4): 609-614. Available from: https://doi.org/10.1016/j. ophtha.2010.12.033.

30. Elman M.J., Ayala A., Bressler N.M. et al. Intravitreal Ranibizumab for Diabetic Macular Edema with Prompt vs. Deferred Laser Treatment: 5-year Randomized Trial Results. Ophthalmology 2015;122(2): 375-381. Available from: https://doi.org/10.1016/j. ophtha.2014.08.047.

31. Brown D.M., Schmidt-Erfurth U., Do D.V. et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122(10): 2044-2052. Available from: https://doi.org/10.1016/j.ophtha.2015.06.017.1.

32. Heier J.S., Korobelnik J.F., Brown et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology 2016;123(11): 2376-2385. Available from: https://doi.org/10.1016/j.ophtha.2016.07.032.

33. American Academy of Ophthalmology Retina/ Vitreous Panel. Preferred Practice Pattern® Guidelines. Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology; 2017.

Fyodorov Journal of Ophthalmic Surgery. 2019; : 67-76

Current approaches to the treatment of diabetic macular edema. A literature review

Bobykin E. V.

https://doi.org/10.25276/0235-4160-2019-1-67-76

Abstract

Despite advances in treatment of diabetes eye complications, diabetic macular edema (DME) remains a common cause of vision loss. Until recently, DME treatment was based on a combination of careful metabolic control and the use of laser photocoagulation. This approach helped to stabilize, but not improve visual function. Also, laser coagulation, despite its effectiveness, is considered as destructive and associated with complications method of treatment. Limited treatment options of diabetic retinopathy led to active research of drugs that can affect complex pathogenetic mechanisms of this disease. The current global experience in treatment allows us to state a paradigm shift in the treatment of DME: antiangiogenic therapy (intravitreal injections of vascular endothelial growth factor-VEGF-inhibitors) is now established as first line therapy. Its effectiveness and safety allowed it to sideline retinal laser coagulation, steroid therapy and vitreoretinal surgery. The article describes the current evidence base for use of anti-VEGF therapy, laser treatment and intravitreal steroids in DME. Article provides data on comparative efficacy and possibility of joint use of various methods of treatment as well as comparison of main anti-angiogenic agents and their treatment regimens.

References

1. Ciulla T.A., Amador A.G., Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies. Diabetes Care.2003;26(9); 2653-2664. Available from: https://doi.org/10.2337/diacare.26.9.2653.

2. Davis M.D., Fisher M.R., Gangnon R.E. et al. Risk factors for high-risk proliferative diabetic retinopathy and severe visual loss: Early Treatment Diabetic Retinopathy Study report number 18. Invest. Ophthalmol. Vis. Sci. 1998;39: 233-252.

3. Zaynullina S.A., Fayzrakhmanov R.R., Yarmukhametova A.L. Diabetic macular edema, clinical manifestations, diagnostic (literature review). Vostok- Zapad; 2012: r.275. (In Russ.).

4. Funatsu H., Noma H., Mimura T. et al. Association of vitreous inflammatory factors with diabetic macular edema. Ophthalmology. 2009;116(1): 73¬79. Available from: https://doi.org/10.1016/j.ophtha. 2008.09.037.

5. Coyne K.S., Margolis M.K., Kennedy-Martin T. et al. The impact of diabetic retinopathy: perspectives from patient focus groups. Fam. Pract. 2004. 21(4); 447-453.

6. American Diabetes Association. Screening for diabetic retinopathy. Diabetes Care. 1997;20: 28-30.

7. Shadrichev F.E. Diabetic Retinopathy (ophthalmologist view). Sakharnyi diabet. 2008;3: 8-11(In Russ.).

8. Singh R., Ramasamy K., Abraham C. et al. Diabetic retinopathy: An update. Indian J. Ophthalmol. 2008;56(3): 179-188.

9. Shaya F.T., Aljawadi M. Diabetic retinopathy Clin Ophthalmol. 2007;1(3); 259-265.

10. Distefano L.N., Garcia-Arumi J., Martinez- Castillo V. et al. Combination of Anti-VEGF and Laser Photocoagulation for Diabetic Macular Edema: A Review. J. Ophthalmol. 2017:2407037. Available from: https:// doi.org/10.1155/2017/2407037.

11. Wong T.Y., Mwamburi M., Klein R. et al. Rates of progression in diabetic retinopathy during different time periods: a systematic review and meta-analysis. Diabetes Care. 2009;32(12): 2307-2313.

12. Au A., Singh R.P A multimodal approach to diabetic macular edema. J. Diabetes Complicat. 2016;30: 545-553. Available from: https://doi.org/10.1016/). jdiacomp.2015.11.008.

13. Demidova T.Y., Trakhtenberg Y.A. Current approaches to the management of diabetic retinopathy. Diabetes mellitus. 2014;17(3):122-128. (in Russ.). Available from: https://doi.org/10.14341/DM20143122-128.

14. Okhocymskaya T.D., Zayceva O.V. Aflibercept in treatment of retinal diseases. Clinical studies review. Rossiiskii oftal’mologicheskii zhurnal. 2017;10(2): 103-111. (In Russ.). Available from: https://doi.org/10.21516/2072-0076-2017-10- 2-103-111.

15. Schmidt-Erfurth U., Garcia-Arumi J., Bandello F. et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2017;237(4): 185-222. Available from: https://doi.org/10.1159/000458539.

16. Early Treatment Diabetic Retinopathy Study Research Group. Techniques for scatter and local photocoagulation treatment of diabetic retinopathy: early treatment diabetic retinopathy study report number 3. International Ophthalmology Clinics. 1987:27(4); 254-264.

17. Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch. Ophthalmol. 1985:103(12); 1796-1806.

18. Luttrull J.K., Dorin G. Subthreshold diode micropulse laser photocoagulation (SDM) as invisible retinal phototherapy for diabetic macular edema: a review. Curr. Diabetes Rev. 2012;8(4): 274-284. Available from: https://doi.org/10.2174/157339912800840523.

19. Schatz H., Madeira D., McDonald H.R. et al. Progressive enlargement of laser scars following grid laser photocoagulation for diffuse diabetic macular edema. Arch. Ophthalmol. 1991;109(11): 1549-1551.

20. Fong D.S., Strauber S.F. et al. Comparison of the modified Early Treatment Diabetic Retinopathy Study and mild macular grid laser photocoagulation strategies for diabetic macular edema. Archives Arch. Ophthalmol. 2007:125(4); 469-480. Available from: https://doi. org/10.1001/archopht.125.4.469.

21. Boyer D.S., Yoon Y.H., Belfort Jr.R. et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014:121(10): 1904-1914. Available from: https://doi.org/10.1016/j. ophtha.2014.04.024.

22. He Y., Ren X.J., Hu B.J. et al. A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema. BMC Ophthalmology. 2018;18(1): 121. Available from: https:// doi.org/10.1186/s12886-018-0779-1.

23. Busch C., Zur D., Fraser-Bell S. et al. Shall we stay, or shall we switch? Continued anti-VEGF therapy versus early switch to dexamethasone implant in refractory diabetic macular edema. Acta diabetologica. 2018:55(8); 789-796. Available from: https://doi.org/10.1007/ s00592-018-1151-x.

24. Iglicki M., Busch C., Zur D. et al. Dexamethasone implant for diabetic macular edema in naive compared with refractory eyes: The International Retina Group Real-Life 24-Month Multicenter Study. The IRGREL-DEX Study. Retina. 2019;39(1): 44-51. Available from: https:// doi.org/10.1097/IAE.0000000000002196.

25. Maturi R.K., Glassman A.R., Liu D. et al. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018;136(1): 29-38. Available from: https://doi.org/10.1001/ jamaophthalmol.2017.4914.

26. Kodjikian L., Decullier E., Souied E.H. et al. Bevacizumab and ranibizumab for neovascular age- related macular degeneration: an updated meta-analysis of randomised clinical trials. Graefe’s Arch. Clin. Exp. Ophthalmol. 2014;252(10): 1529-1537. Available from: https://doi.org/10.1007/s00417-014-2764-6.

27. 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(2): 171-185. Available from: https://doi.org/10.1007/s10456-011- 9249-6.

28. Diabetic Retinopathy Clinical Research Network, Elman M. J., Aiello L. P., et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010;117(6): 1064- 1077.e35. Available from: https://doi.org/10.1016/j. ophtha.2010.02.031.

29. Elman M.J., Bressler N.M., Qin H. et al. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011;118(4): 609-614. Available from: https://doi.org/10.1016/j. ophtha.2010.12.033.

30. Elman M.J., Ayala A., Bressler N.M. et al. Intravitreal Ranibizumab for Diabetic Macular Edema with Prompt vs. Deferred Laser Treatment: 5-year Randomized Trial Results. Ophthalmology 2015;122(2): 375-381. Available from: https://doi.org/10.1016/j. ophtha.2014.08.047.

31. Brown D.M., Schmidt-Erfurth U., Do D.V. et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122(10): 2044-2052. Available from: https://doi.org/10.1016/j.ophtha.2015.06.017.1.

32. Heier J.S., Korobelnik J.F., Brown et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology 2016;123(11): 2376-2385. Available from: https://doi.org/10.1016/j.ophtha.2016.07.032.

33. American Academy of Ophthalmology Retina/ Vitreous Panel. Preferred Practice Pattern® Guidelines. Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology; 2017.