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Российский офтальмологический журнал

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Лечение заболеваний макулы: резюме ключевых рандомизированных клинических исследований

https://doi.org/10.21516/2072-0076-2021-14-4-137-148

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Аннотация

Рандомизированные клинические исследования предоставили офтальмологам ценную информацию о естественном течении и стратегиях лечения распространенных заболеваний сетчатки с позиций медицины, основанной на доказательствах. В данном обзоре предпринята попытка систематизировать наиболее значимые из них. Выбраны 42 рандомизированных исследования, проведенных с 1979 по 2019 г. и посвященных лечению возрастной макулярной дегенерации (AREDS 1, AREDS 2, ANCHOR, MARINA, PrONTO, CATT, IVAN, VIEW 1, VIEW 2, EVEREST II, PLANET, SEVEN-UP, ALTAIR, HAWK, HARRIER), хориоидальной неоваскуляризации различной этиологии (миопической, поствоспалительной, на фоне ангиоидных полос и др. — RADIANCE, REPAIR, MYRROR, MINERVA), диабетических поражений глаз (диабетической ретинопатии и диабетического макулярного отека — ETDRS, протоколы B, I, S и T DRCR.net, RISE, RIDE, VIVID-DME, VISTA-DME, MEAD, FAME), а также окклюзий вен сетчатки (BVOS, CVOS, SCORE-CRVO, SCORE-BRVO, BRAVO, CRUISE, GALILEO, COPERNICUS, VIBRANT) и ретинопатии недоношенных (CRYO-ROP, ETROP, RAINBOW). Приводятся основные данные, обосновывающие с позиций доказательной медицины эффективность и безопасность применения таких методов лечения, как антивазопролиферативная и фотодинамическая терапия, лазерная коагуляция сетчатки, криотерапия, использование кортикостероидов и витаминно-минеральных комплексов. Их результаты сформировали парадигмы ведения заболеваний и оказали определяющее влияние на развитие современной ретинологии. Для большей наглядности представлена таблица, в которой обобщена краткая информация о каждом из рассмотренных рандомизированных клинических исследований.

Об авторах

Е. В. Бобыкин
ФГБОУ ВО «Уральский государственный медицинский университет» Минздрава России
Россия

Евгений Валерьевич Бобыкин — канд. мед. наук, доцент, доцент кафедры офтальмологии

ул. Репина, д. 3, Екатеринбург, 620028



О. В. Морозова
ФГБОУ ВО «Уральский государственный медицинский университет» Минздрава России
Россия

Ольга Викторовна Морозова — врач-офтальмолог, соискатель кафедры офтальмологии

ул. Репина, д. 3, Екатеринбург, 620028

 



Н. С. Береснева
ФГБОУ ВО «Уральский государственный медицинский университет» Минздрава России
Россия

Надежда Сергеевна Береснева — клинический ординатор кафедры офтальмологии

ул. Репина, д. 3, Екатеринбург, 620028



Список литературы

1. Age-Related Eye Disease Study Research Group. A randomized, placebocontrolled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Archives Ophthalmol. 2001; 119 (10): 1417–36. doi: 10.1001/archopht.119.10.1417

2. Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS 2) randomized clinical trial. JAMA. 2013; 309 (19): 2005–15. doi: 10.1001/jama.2013.4997

3. Brown D.M., Michels M., Kaiser P.K., et al. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Twoyear results of the ANCHOR study. Ophthalmology. 2009; 116 (1): 57–65.e55. doi: 10.1016/j.ophtha.2008.10.018

4. Rosenfeld P.J., Brown D.M., Heier J.S., et al. Ranibizumab for neovascular age-related macular degeneration. N. Engl. J. Med. 2006; 355 (14): 1419–31. doi: 10.1056/NEJMoa054481

5. Lalwani G.A., Rosenfeld P.J., Fung A.E., 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. doi: 10.1016/j.ajo.2009.01.024

6. Martin D.F., Maguire M.G., Fine S.L., et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology. 2012; 119 (7): 1388–98. doi: 10.1016/j.ophtha.2012.03.053

7. Chakravarthy U., Harding S.P., Rogers C.A., et al. 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. doi: 10.1016/S0140-6736(13)61501-9

8. Heier J.S., Brown D.M., Chong V., et al. Intravitreal aflibercept (VEGF trapeye) in wet age-related macular degeneration. Ophthalmology. 2012; 119 (12): 2537–48. doi: 10.1016/j.ophtha.2012.09.006

9. Koh A., Lai T.Y.Y., Takahashi K., et al. Efficacy and safety of ranibizumab with or without verteporfin photodynamic therapy for polypoidal choroidal vasculopathy: a randomized clinical trial. JAMA Ophthalmol. 2017; 135 (11): 1206–13. doi:10.1001/jamaophthalmol.2017.4030.

10. Lee W.K., Iida T., Ogura Y., et al. Efficacy and safety of intravitreal aflibercept for polypoidal choroidal vasculopathy in the PLANET study: a randomized clinical trial. JAMA Ophthalmol. 2018; 136 (7): 786–93. doi:10.1001/jamaophthalmol.2018.1804

11. Wong T.Y., Ogura Y., Lee W.K., et al. Efficacy and safety of intravitreal Aflibercept for polypoidal choroidal vasculopathy: two-year results of the Aflibercept in polypoidal choroidal vasculopathy study. Am. J. Ophthalmol. 2019; 204: 80–9. doi: 10.1016/j.ajo.2019.02.027

12. Rofagha S., Bhisitkul R.B., Boyer D.S., Sadda S.R., Zhang K. Seven-year outcomes in ranibizumab-treated patients in ANCHOR, MARINA, and HORIZON: a multicenter cohort study (SEVEN-UP). Ophthalmology. 2013; 120 (11): 2292–9. doi: 10.1016/j.ophtha.2013.03.046

13. Ohji M., Takahashi K., Okada A.A., et al. Efficacy and safety of intravitreal aflibercept treat-and-extend regimens in exudative age-related macular degeneration: 52- and 96-week findings from ALTAIR. Adv Ther. 2020; 37 (3): 1173–87. https://doi.org/10.1007/s12325-020-01236-x

14. Dugel P.U., Koh A., Ogura Y., et al. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020; 127 (1): 72–84. doi: 10.1016/j.ophtha.2019.04.017

15. Dugel P.U., Singh R.P., Koh A., et al. HAWK and HARRIER: Ninety-six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2021; 128 (1): 89–99. doi: 10.1016/j.ophtha.2020.06.028

16. Wolf S., Balciuniene V.J., Laganovska G., et al. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014; 121 (3): 682–92.e2. doi: 10.1016/j.ophtha.2013.10.023

17. Tan N.W., Ohno-Matsui K., Koh H.J., et al. Long-term outcomes of ranibizumab treatment of myopic choroidal neovascularization in East-Asian patients from the RADIANCE study. Retina. 2018; 38 (11): 2228–38. doi: 10.1097/IAE.0000000000001858

18. Tufail A., Narendran N., Patel P.J., et al. Ranibizumab in myopic choroidal neovascularization: the 12-month results from the REPAIR study. Ophthalmology. 2013; 120 (9): 1944–5.e1. doi: 10.1016/j.ophtha.2013.06.010

19. Ikuno Y., Ohno-Matsui K., Wong T.Y., et al. Intravitreal aflibercept injection in patients with myopic choroidal neovascularization: the MYRROR study. Ophthalmology. 2015; 122 (6): 1220–7. doi: 10.1016/j.ophtha.2015.01.025

20. Lai T.Y., Staurenghi G., Lanzetta P., et al. Efficacy and safety of ranibizumab for the treatment of choroidal neovascularization due to uncommon cause: twelve-month results of the MINERVA study. Retina. 2018; 38 (8): 1464–77. doi: 10.1097/IAE.0000000000001744

21. Early Treatment Diabetic Retinopathy Study Research Group. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Ophthalmology. 1987; 94 (7): 761–74.

22. Early Treatment Diabetic Retinopathy Study Research Group. Effects of aspirin treatment on diabetic retinopathy. ETDRS report number 8. Ophthalmology. 1991; 98 (5 Suppl): 757–65.

23. Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2008; 115 (9): 1447–9. doi: 10.1016/j.ophtha.2008.06.015

24. Elman M.J., Ayala A., Bressler N.M., et al. Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: 5-year randomized trial results. Ophthalmology. 2015; 122 (2): 375–81. doi: 10.1016/j.ophtha.2014.08.047

25. Wells J.A., Glassman A.R., Ayala A.R., et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology. 2016; 123 (6): 1351–9. doi: 10.1016/j.ophtha.2016.02.022

26. Gross J.G., Glassman A.R., Jampol L.M., et al. Panretinal photocoagulation vs intravitreous ranibizumab for proliferative diabetic retinopathy: a randomized clinical trial. JAMA. 2015; 314 (20): 2137–46. doi: 10.1001/jama.2015.15217

27. Nguyen Q.D., Brown D.M., Marcus D.M., et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012; 119 (4): 789–801. doi: 10.1016/j.ophtha.2011.12.039

28. Korobelnik J.F., Do D.V., Schmidt-Erfurth U., et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014; 121 (11): 2247–54. doi: 10.1016/j.ophtha.2014.05.006

29. Boyer D.S., Yoon Y.H., Belfort R.Jr., et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014; 121 (10): 1904–14. doi: 10.1016/j.ophtha.2014.04.024

30. Campochiaro P.A., Brown D.M., Pearson A., et al. Long-term benefit of sustaineddelivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011; 118 (4): 626–35. doi: 10.1016/j.ophtha.2010.12.028

31. Branch Vein Occlusion Study Group. Argon laser photocoagulation for macular edema in branch vein occlusion. Am. J. Ophthalmol. 1984 Sep; 98 (3): 271–82. doi: 10.1016/0002-9394(84)90316-7

32. Central Vein Occlusion Study Group. Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995 Oct; 102 (10): 1425–33. doi: 10.1016/s0161-6420(95)30849-4

33. Ip M.S., Scott I.U., VanVeldhuisen P.C., et al. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5. Arch. Ophthalmol. 2009; 127 (9): 1101–14. doi: 10.1001/archophthalmol.2009.234

34. Scott I.U., Ip M.S., VanVeldhuisen P.C., et al. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular edema secondary to branch retinal vein occlusion: The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6. Arch Ophtahlmol. 2009; 127 (9): 1115–28. doi: 10.1001/archophthalmol.2009.233

35. Brown D.M., Campochiaro P.A., Bhisitkul R.B., et al. Sustained benefits from ranibizumab for macular edema following branch retinal vein occlusion: 12-month outcomes of a phase III study. Ophthalmology. 2011; 118 (8): 1594–602. doi: 10.1016/j.ophtha.2011.02.022

36. Brown D.M., Campochiaro P.A., Singh R.P., et al. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010; 117 (6): 1124–33.e1121. doi: 10.1016/j.ophtha.2010.02.022

37. Korobelnik J.F., Holz F.G., Roider J., et al. Intravitreal aflibercept injection for macular edema resulting from central retinal vein occlusion: one-year results of the phase 3 GALILEO Study. Ophthalmology. 2014; 121 (1): 202–8. doi: 10.1016/j.ophtha.2013.08.012

38. Heier J.S., Clark W.L., Boyer D.S., et al. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014; 121 (7): 1414–20. doi: 10.1016/j.ophtha.2014.01.027

39. Clark W.L., Boyer D.S., Heier J.S., et al. Intravitreal aflibercept for macular edema following branch retinal vein occlusion: 52-week results of the VIBRANT Study. Ophthalmology. 2016; 123 (2): 330–6. doi: 10.1016/j.ophtha.2015.09.035

40. Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Cryotherapy for retinopathy of prematurity cooperative group. Arch. Ophthalmol. 1988; 106 (4): 471–9. doi: 10.1001/archopht

41. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity: ophthalmological outcomes at 10 years. Arch Ophthalmol. 2001; 119 (8): 1110–8. doi: 10.1001/archopht.119.8.1110

42. Good W.V. Early Treatment for Retinopathy of Prematurity Cooperative Group. Final results of the Early Treatment for Retinopathy of Prematurity (ETROP) randomized trial. Trans. Am. Ophthalmol. Soc. 2004; 102: 233–50. PMID: 15747762

43. Stahl A., Lepore D., Fielder A., et al. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial. Lancet. 2019; 394 (10208): 1551–9. doi: 10.1016/S0140-6736(19)31344-3


Для цитирования:


Бобыкин Е.В., Морозова О.В., Береснева Н.С. Лечение заболеваний макулы: резюме ключевых рандомизированных клинических исследований. Российский офтальмологический журнал. 2021;14(4):137-148. https://doi.org/10.21516/2072-0076-2021-14-4-137-148

For citation:


Bobykin E.V., Morozova O.V., Beresneva N.S. Treatment of macular diseases: an overview of key randomized clinical trials. Russian Ophthalmological Journal. 2021;14(4):137-148. (In Russ.) https://doi.org/10.21516/2072-0076-2021-14-4-137-148

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ISSN 2072-0076 (Print)
ISSN 2587-5760 (Online)