Анти-VEGF терапия макулярного отека
Ключевые слова:
заболевания сетчатки, макулярный отек, фактор роста эндотелия сосудов, ангиопоэтины, анти-VEGF препаратыАннотация
Развитие макулярного отека при неоваскулярной возрастной макулярной дегенерации, диабетической ретинопатии,
окклюзии вен сетчатки и при ряде других заболеваний часто становится причиной существенного снижения зрения
и слепоты, причем нередко у людей трудоспособного возраста. Одним из методов лечения данных заболеваний является интравитреальное введение анти-VEGF препаратов, включающих ранибизумаб, афлиберцепт, бролуцизумаб и др.
Новым препаратом, воздействующим как на фактор роста эндотелия сосудов, так и на ангиопоэтины, является фарицимаб. С целью уменьшения частоты интравитреальных инъекций и продления времени действия препарата разработаны устройства пролонгированного действия: портовые системы доставки лекарств и биоразлагаемые препараты.
Библиографические ссылки
Охоцимская Т.Д., Зайцева О.В. Афлиберцепт для терапии заболеваний сетчатки. Обзор клинических исследований. Российский офтальмологический журнал. 2017;10(2):103-111. [Okhotsimskaya T.D., Zaitseva O.V. Aflibercept for the therapy of retinal diseases. A review of clinical studies. Russian ophthalmological journal. 2017;10(2):103–111. (In Russ.)]. doi: 10.21516/2072-0076-2017-10-2-103-111
2. Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocr. Rev. 2004;25:581–611. doi:10.1210/ er.2003-0027
3. Борзилова Ю.А., Болдырева Л.А., Шлык И.В. Васкулоэндотелиальные факторы роста (VEGF): роль и место в патологических процессах. Вестник офтальмологии. 2016;132(4):98–103. [Borzilova YuA, Boldyreva LA, Shlyk IV. Vascular endothelial growth factors (VEGF): role in pathological processes. Vestnik Oftalmologii. 2016;132(4):98–103. (In Russ.)]. doi: 10.17116/oftalma2016132498-103
4. Исхакова А.Г., Золотарев А.В., Викторов Д.А. и др. Роль факторов роста сосудов в развитии диабетической ретинопатии и макулярного отека. Российский офтальмологический журнал. 2018;11(2):62–9. [Iskhakova AG, Zolotarev AV, Viktorov DA et al. The role of vascular growth factors in diabetic retinopathy and macular edema development. Russian ophthalmological journal. 2018;11(2):62–69. (In Russ.)]. doi: 10.21516/2072-0076-2018-11-2-62-69
5. Hussain RM, Neiweem AE, Kansara V et al. Tie2/Angiopoietin pathway modulation as a therapeutic strategy for retinal disease. Expert Opinion on Investigational Drugs. 2019;28(10):861–869. doi: 10.1080/13543784.2019.1667333
6. Fabre M, Mateo L, Lamaa D, et al. Recent Advances in Age-Related Macular Degeneration Therapies. Molecules. 2022;10;27(16):5089. doi: 10.3390/molecules27165089
7. Kiire CA, Morjaria R, Rudenko A, et al. Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema. Clinical Ophthalmology. 2015;20152305. doi:10.2147/opth.s90322
8. Furino C, Boscia F, Reibaldi M, Alessio G. Intravitreal Therapy for Diabetic Macular Edema: An Update. J. Ophthalmol. 2021;23. doi: 10.1155/2021/6654168
9. 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):1388–1398. doi: 10.1016/j.ophtha.2012.03.053
10. Евграфов В.Ю., Кудашева Г.Р. Применение ингибиторов ангиогенеза у пациентов с пролиферативной диабетической ретинопатией. Офтальмология. 2022;19(2):405–412. [Evgrafov VYu, Kudasheva GR. The Use of Vascular Endothelial Growth Factor Inhibitors in Patients with Proliferative Diabetic Retinopathy. Ophthalmology in Russia. 2022;19(2):405–412. (In Russ.)]. doi: 10.18008/1816-5095-2022-2-405-412
11. Ferrara N, Damico L, Shams N, et al. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina. 2006;26(8):859–870. doi: 10.1097/01. iae.0000242842.14624.e7
12. Rosenfeld P., Brown DM, Heier JS, et al. MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N. Engl. J. Med. 2006;355(14):1419–1431. doi: 10.1056/NEJMoa054481
13. Brown DM, Michels M, Kaiser PK, 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
14. Nguyen QD, Brown DM, Marcus DM et al. RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789–801. doi: 10.1016/j.ophtha.2011.12.039
15. Бобыкин Е.В., Морозова О.В., Береснева Н.С. Лечение заболеваний макулы: резюме ключевых рандомизированных клинических исследований. Российский офтальмологический журнал. 2021;14 (4):137–48. [Bobykin EV, Morozova OV, Beresneva NS. Treatment of macular diseases: an overview of key randomized clinical trials. Russian ophthalmological journal. 2021;14(4):137–148 (In Russ.)]. doi:10.21516/2072-0076-2021-14-4-137-148
16. Brown DM, Campochiaro PA, Bhisitkul RB, 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):1594–1602. doi: 10.1016/j.ophtha.2011.02.022
17. Brown DM, Campochiaro PA, Singh RP, et al. CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117(6):1124–1133.e1. doi: 10.1016/j. ophtha.2010.02.022
18. Wolf S, Balciuniene VJ, Laganovska G, et al. RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014;121(3):682–692.e2. doi: 10.1016/j.ophtha.2013.10.023
19. Tan NW, Ohno-Matsui K, Koh HJ, et al. Long-term outcomes of ranibizumab treatment of myopic choroidal neovascularization in east asian patients from the radiance study. Retina. 2018;38(11):2228–2238. doi: 10.1097/IAE.0000000000001858
20. Fleck BW, Reynolds JD, Zhu Q, et al. RAINBOW Investigator Group. Time Course of Retinopathy of Prematurity Regression and Reactivation After Treatment with Ranibizumab or Laser in the RAINBOW Trial. Ophthalmol Retina. 2022;6(7):628–637. doi: 10.1016/j.oret.2022.02.006
21. Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF trapeye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537–2548. doi: 10.1016/j.ophtha.2012.09.006
22. Fabre M, Mateo L, Lamaa D, et al. Recent Advances in Age-Related Macular Degeneration Therapies. Molecules. 2022;10;27(16):5089. doi: 10.3390/molecules27165089
23. Moradi A, Sepah YJ, Sadiq MA, et al. Vascular endothelial growth factor trap-eye (Aflibercept) for the management of diabetic macular edema. World J. Diabetes. 2013; 4:303–309. doi: 10.4239/ wjd.v4.i6.303
24. Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016;123:2376–2385. doi: 10.1016/j.ophtha.2016.07.032
Korobelnik JF, Holz FG, Roider J, et al. GALILEO Study Group. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study. Ophthalmology J. 2014;121(1):202–208. doi: 10.1016/j.ophtha.2013.08.012
26. Heier JS, Clark WL, Boyer DS, et al. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: twoyear results from the COPERNICUS study. Ophthalmology. 2014;121(7):1414–1420.e1. doi: 10.1016/j.ophtha.2014.01.027
27. Ikuno Y, Ohno-Matsui K, Wong TY, et al. MYRROR Investigators. Intravitreal Aflibercept Injection in Patients with Myopic Choroidal Neovascularization: The MYRROR Study. Ophthalmology. 2015;122(6):1220–1227. doi: 10.1016/j.ophtha.2015.01.025
28. Будзинская М.В., Плюхова А.А. Перспективы антиангиогенной терапии при заболеваниях сетчатки. Офтальмология. 2021;18(3S):638–645. [Budzinskaya MV, Plyukhova. AA. Future Perspectives for Antiangiogenic Therapy in Retinal Diseases. Ophthalmology. 2021;18(3S):638–645. (In Russ.)]. doi:10.18008/1816-5095-2021-3S-638-645
29. Yannuzzi NA, Freund KB. Brolucizumab: evidence to date in the treatment of neovascular age-related macular degeneration. Clin. Ophthalmol. 2019;13:1323–1329. doi: 10.2147/opth.s184706
30. Dugel PU, Singh RP, 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
31. A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema. Available online: https://clinicaltrials.gov/ct2/show/NCT03481660 [Accessed on 2d March 2022]
32. Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema. Available online: https://clinicaltrials.gov/ct2/show/ NCT03481634 [Accessed on 28th October 2022]
33. Al-Khersan H, Hussain RM, Ciulla TA, Dugel PU. Innovative therapies for neovascular age-related macular degeneration. Expert. Opin. Pharmacother. 2019;20(15):1879–1891. doi: 10.1080/14656566.2019.1636031
34. Heier JS, Khanani AM, Quezada RC, et al. TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non inferiority trials. Lancet. 2022 Feb 19;399(10326):729–740. doi: 10.1016/S0140-6736(22)00010-1
35. Wykoff CC, Abreu F, Adamis AP, et al. YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022;19;399(10326):741–755. doi: 10.1016/S0140-6736(22)00018-6
36. Гаврилова Н.А., Гаджиева Н.С., Тищенко О.Е., Зиновьева А.В. Анализ результатов проведения клинических исследований при неоваскулярной возрастной макулярной дегенерации за 2005–2020 гг. Обзор литературы. Офтальмология. 2022;19(1):22–32. [Gavrilova NA, Gadzhieva NS, Tishchenko OE, Zinoveva AV. Analysis of Clinical Study Results Obtained in Patients with Neovascular Age-Related Macular Degeneration in 2005–2020. Review. Ophthalmology in Russia. 2022;19(1):22–32.] doi:10.18008/1816-5095-2022-1-22-32
37. Khurana RN, Kunimoto D, Yoon YH, et al. CEDAR and SEQUOIA Study Groups. Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2021;128(7):1027–1038. doi: 10.1016/j.ophtha.2020.11.017
38. Dugel PU. Clinical trial download: Data on Abicipar From the MAPLE Study. A new formulation showed reduced inflammation rates. Retinal Physician. 2019;18,42. Available from: https://www.retinalphysician.com/issues/2019/june-2019/clinical-trialdownload-safety-and-efficacy-data [Accessed 30th November 2022]
39. Chandrasekaran PR, Madanagopalan VG. KSI-301: antibody biopolymer conjugate in retinal disorders. Ther. Adv. Ophthalmol. 2021;12;13:25158414211027708. doi: 10.1177/25158414211027708
40. A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti- VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. Available online: https://clinicaltrials.gov/ct2/show/study/NCT04049266 [Accessed on 6th June 2022]
41. A Trial to Evaluate the Efficacy Durability and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME). Available online: https://clinicaltrials.gov/ct2/show/NCT04611152 [Accessed on 6th June 2022]
42. A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME). Available online: https://clinicaltrials.gov/ct2/show/NCT04603937 [Accessed on 6th June 2022]
43. A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO). Available online: https://clinicaltrials.gov/ct2/show/NCT04592419 [Accessed on 22th July 2022]
44. Hussain RM, Shaukat BA, Ciulla LM, et al. Vascular Endothelial Growth Factor Antagonists: Promising Players in the Treatment of Neovascular Age-Related Macular Degeneration. Drug. Des. Devel. Ther. 2021;21;15:2653–2665. doi: 10.2147/DDDT.S295223
45. OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD). Available online: https://clinicaltrials.gov/ct2/show/record/NCT04757610 [Accessed on 8th September 2022]
46. OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD). Available online: https://clinicaltrials.gov/ct2/show/study/NCT04757636 [Accessed on 8th September 2022]
47. Клинические рекомендации: Возрастная макулярная дегенерация. Общероссийская общественная организация «Ассоциация врачей-офтальмологов». 2021. Доступно онлайн: http://avo-portal.ru/doc/fkr/item/398-vozrastnaya-makulyarnayadegeneratsiya Clinical guidelines: Age-related macular degeneration. All-Russian public organization «Association of ophthalmologists». 2021 (in Russ.). Available online: http://avo-portal.ru/doc/fkr/item/398-vozrastnaya-makulyarnayadegeneratsiya
48. Иошин И.Э., Аноприева Т.А. Подходы к назначению антиангиогенных препаратов при терапии пациентов с неоваскулярной возрастной макулярной дегенерацией. Российский офтальмологический журнал. 2019;12(3):102–12. [Ioshin IE, Anoprieva TA. Principles of anti-VEGF dosing in the treatment of neovascular agerelated macular degeneration. Russian ophthalmological journal. 2019;12(3):102–112 (In Russ.)]. doi: 10.21516/2072-0076-2019-12-3-102-112
49. Holekamp NM, Campochiaro PA, Chang MA et al. Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022;129(3):295–307. doi: 10.1016/j.ophtha.2021.09.016
50. A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm. Available online: https://clinicaltrials.gov/ct2/show/record/NCT04503551 [Accessed on 5th August 2022]
51. Xu M, Fan R, Fan X, et al. Progress and Challenges of Anti-VEGF Agents and Their Sustained-Release Strategies for Retinal Angiogenesis. Drug. Des. Devel. Ther. 2022;22;16:3241–3262. doi: 10.2147/DDDT.S383101
52. Study Evaluating the Treatment of OTX-TKI for Subjects with Neovascular Age-Related Macular Degeneration. Available online: https://clinicaltrials.gov/ct2/show/NCT04989699 [Accessed on 6th September 2022]
53. A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD. Available online: https:// clinicaltrials.gov/ct2/show/study/NCT03953079 [Accessed on 19th January 2022]
