Офтальмохирургия. 2018; : 59-65
Сравнение эффективности различных протоколов перехода на афлиберцепт при тахифилаксии к ранибизумабу у пациентов с неоваскулярной возрастной макулярной дегенерацией
https://doi.org/10.25276/0235-4160-2018-3-59-65Аннотация
Цель. Провести сравнительный анализ эффективности различных режимов антиангиогенной терапии неоваскулярной возрастной макулярной дегенерации (ВМД) при смене ингибитора ангиогенеза с ранибизумаба на афлиберцепт.
Материал и методы. Проспективное интервенционное сравнительное немаскированное контролируемое клиническое исследование было проведено в 4 группах испытуемых, получивших не менее 5 интравитреальных инъекций (ИВИ) ранибизумаба. Продолжение лечения проводили в 1-3 группах афлиберцептом, в 1 группе – с проведением инициального курса из 3 ИВИ и далее 1 ИВИ каждые 2 мес., во второй группе без инициального курса – 1 ИВИ каждые 2 мес., в 3 группе – в режиме PRN (pro re nata), в 4 группе продолжали лечение ранибизумабом в режиме PRN. Наблюдение за пациентами осуществляли в течение 11 мес., оценивалась МКОЗ (максимально корригированная острота зрения) и толщина центральной сетчатки (ТЦС).
Результаты. В группе 1 из 12 пациентов (14 глаз) выполнено по 7 ИВИ, ТЦС уменьшилась на 131±78 мкм (p<0,05). В группе 2 из 18 пациентов (19 глаз) выполнено по 6 ИВИ, ТЦС уменьшилась на 131±58 мкм (p<0,05). В 3 группе 14 пациентов (16 глаз) среднее количество ИВИ составило 4,1±1,9, ТЦС достоверно не изменилась. В
контрольной группе из 25 пациентов выполнено в среднем 4,6±2,1 ИВИ, достоверных изменений ТЦС не наблюдалось. Достоверных изменений МКОЗ не наблюдалось ни в одной группе, вместе с тем частота улучшения остроты зрения была выше в 1-3 группах (37,5- 42,8%) по сравнению с контрольной – 24,0%.
Выводы. При смене ингибитора ангиогенеза с ранибизумаба на афлиберцепт в фазе поддержания регулярной антиангиогенной терапии неоваскулярной ВМД режим ИВИ 1 раз в 2 мес. обеспечивает лучший результат при наименьшем количестве ИВИ.
Список литературы
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14. Eghоj M.S., Sorensen T.L. Tachyphylaxis during treatment of exudative age-related macular degeneration with ranibizumab // Br. J Ophthalmol. – 2012. – Vol. 96 (1). – Р. 1-2, 21-23.
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17. Grewal D.S., Gill M.K., Sarezky D. et al. Visual and anatomical outcomes following intravitreal aflibercept in eyes with recalcitrant neovascular age-related macular degeneration: 12-month results // Eye. – 2014. – Vol. 28. – Р. 895-899.
18. Heier J.S., Brown D., Chong V. et al. Ophthalmology. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration // Ophthalmology. – 2012. – Vol. 119, № 12. – P. 2537-2548.
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20. Lazzeri S., Ripandelli G., Sartini MS. et al. Aflibercept administration in neovascular agerelated macular degeneration refractory to previous anti-vascular endothelial growth factor drugs: a critical review and new possible approaches to move forward // Angiogenesis. – 2015. – Vol. 18. – Р. 397-432.
21. Pinheiro-Costa J., Pinheiro A.F., Meira J. et al. Switch to Aflibercept in the Treatment of Neovascular AMD: One-Year Results in Clinical Practice // Ophthalmologica. – 2015. – 233 (3-4). – Р. 155-161.
22. Rosenfeld P.J., Brown D.M., Heier J.S. et al. Ranibizumab for neovascular age-related macular degeneration // N. Engl. J. Med. – 2006. – Vol. 355 (14). – Р. 1419-1431.
23. Schmidt-Erfurth U., Kaiser P., Korobelnik J.F. Intravitreal aflibercept injection for neovascular agerelated macular degeneration: ninety-six-week results of the VIEW studies // Ophthalmology. – 2014. – Vol. 121, Vol. 1. – P. 193-201.
24. Stahl A. Anti-angiogenic therapy in ophthalmology // Essentials in Ophtalmology. – Germany: Springer, 2016. – P. 193.
25. Stewart M.W., Rosenfeld PJ. Predicted biological activity of intravitreal VEGF Trap // Br. J. Ophthalmol. – 2008. – Vol. 92 (5). – P. 667-668.
26. Wykoff C.C., Brown D., Maldonado M. et al. Aflibercept treatment for patients with exudative agerelated macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial) // Br. J. Ophthalmol. – 2014. – Vol. 98, № 7. – P. 951-955.
Fyodorov Journal of Ophthalmic Surgery. 2018; : 59-65
Comparison of the effectiveness of various protocols for the transition to aflibercept with tachyphylaxis for ranibizumab in patients with neovascular AMD
https://doi.org/10.25276/0235-4160-2018-3-59-65Abstract
Purpose. Expanding the range of angiogenesis inhibitors allows the creation of treatment regimens with a change in the drug to increase the effectiveness of treatment. The aim of the study was to perform a comparative analysis of the efficacy of different regimes of antiangiogenic therapy for neovascular age-related macular degeneration (nAMD) with a change in inhibitor of angiogenesis from ranibizumab to aflibercept.
Material and methods. A prospective interventional comparative non-masked controlled clinical trial was conducted in 4 groups of subjects who received at least 5 intravitreal injection of ranibizumab (IVR). Continuation of treatment was carried out in 1-3 groups with aflibercept, in group 1 with an initial course of 3 IVI and then 1 IVI every 2 months, in the second group without an initial course, 1 IVI every 2 months, in group 3 in PRN mode, 4 the group was treated with ranibizumab in PRN mode. Patients were monitored for 11 months, assessed by BCVA (best corrected visual acuity) and TCR (thickness of the centr al retina).
Results. In group 1, 12 patients (14 eyes) completed, 7 IVI completed, TCR decreased by 131±78 μm (p<0.05). In group 2, 18 patients (19 eyes) completed, 6 of the IVI completed, decreased by 131±58 μm (p<0.05). In the 3rd group, 14 patients (16 eyes) completed the study, the average number of IVI was 4.1±1.9, the TCR did not change significantly. In the control group, a study of 25 patients was completed, an average of 4.6±2.1 IVI was performed, no significant changes in TCR were observed. There were no significant changes in BCVA (best corrected visual acuity) in any group, however, the frequency of improvement in visual acuity was higher in 1-3 groups (37.5-42.8%) compared with the control 24.0%.
Conclusions. When the angiogenesis inhibitor with ranibizumab is switched to aflibercept in the phase of maintaining a regular antiangiogenic therapy for neovascular age-related macular degeneration (nAMD), the IVI regimen provides the best result with the least amount of IVI every 2 months.
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11. Chang A.A., Li H., Broadhead G. et al. Intravitreal aflibercept for treatment-resistant neovascular agerelated macular degeneration // Ophthalmology. – 2014. – Vol. 121. – R. 188-192.
12. Chong V. Ranibizumab for the treatment of wet AMD: a summary of real-world studies // Eye (Lond.). – 2016. – Nov. – Vol. 30 (11). – P. 1526.
13. Das A., Friberg T. Therapy for ocular angiogenesis: Principles and Practice. – Philadelphia: LWW, 2011. – P. 377.
14. Eghoj M.S., Sorensen T.L. Tachyphylaxis during treatment of exudative age-related macular degeneration with ranibizumab // Br. J Ophthalmol. – 2012. – Vol. 96 (1). – R. 1-2, 21-23.
15. Ferrara N., Henzel W.J. Pituitary follicular cells secrete a novel heparin-binding growth factor specific for vascular endothelial cells // Biochem Biophys Res Commun. – 1989. – Vol. 161. – P. 851-858.
16. Gasperini J.L., Fawzi A., Khondkaryan A. et al. Bevacizumab and ranibizumab tachyphylaxis in the treatment of choroidal neovascularization // Br. J. Ophthalmol. – 2012. – Vol. 96 (1). – R. 14-20.
17. Grewal D.S., Gill M.K., Sarezky D. et al. Visual and anatomical outcomes following intravitreal aflibercept in eyes with recalcitrant neovascular age-related macular degeneration: 12-month results // Eye. – 2014. – Vol. 28. – R. 895-899.
18. Heier J.S., Brown D., Chong V. et al. Ophthalmology. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration // Ophthalmology. – 2012. – Vol. 119, № 12. – P. 2537-2548.
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20. Lazzeri S., Ripandelli G., Sartini MS. et al. Aflibercept administration in neovascular agerelated macular degeneration refractory to previous anti-vascular endothelial growth factor drugs: a critical review and new possible approaches to move forward // Angiogenesis. – 2015. – Vol. 18. – R. 397-432.
21. Pinheiro-Costa J., Pinheiro A.F., Meira J. et al. Switch to Aflibercept in the Treatment of Neovascular AMD: One-Year Results in Clinical Practice // Ophthalmologica. – 2015. – 233 (3-4). – R. 155-161.
22. Rosenfeld P.J., Brown D.M., Heier J.S. et al. Ranibizumab for neovascular age-related macular degeneration // N. Engl. J. Med. – 2006. – Vol. 355 (14). – R. 1419-1431.
23. Schmidt-Erfurth U., Kaiser P., Korobelnik J.F. Intravitreal aflibercept injection for neovascular agerelated macular degeneration: ninety-six-week results of the VIEW studies // Ophthalmology. – 2014. – Vol. 121, Vol. 1. – P. 193-201.
24. Stahl A. Anti-angiogenic therapy in ophthalmology // Essentials in Ophtalmology. – Germany: Springer, 2016. – P. 193.
25. Stewart M.W., Rosenfeld PJ. Predicted biological activity of intravitreal VEGF Trap // Br. J. Ophthalmol. – 2008. – Vol. 92 (5). – P. 667-668.
26. Wykoff C.C., Brown D., Maldonado M. et al. Aflibercept treatment for patients with exudative agerelated macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial) // Br. J. Ophthalmol. – 2014. – Vol. 98, № 7. – P. 951-955.
