<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">helmholtzeyeinstitute</journal-id><journal-title-group><journal-title xml:lang="ru">Российский офтальмологический журнал</journal-title><trans-title-group xml:lang="en"><trans-title>Russian Ophthalmological Journal</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2072-0076</issn><issn pub-type="epub">2587-5760</issn><publisher><publisher-name>Real time Publishers</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.21516/2072-0076-2019-12-2-97-105</article-id><article-id custom-type="elpub" pub-id-type="custom">helmholtzeyeinstitute-279</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРЫ ЛИТЕРАТУРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>Анти-VEGF терапия неоваскулярной возрастной макулярной дегенерации: от рандомизированных исследований к реальной клинической практике</article-title><trans-title-group xml:lang="en"><trans-title>Anti-VEGF therapy of neovascular age-related macular degeneration: from randomized trials to routine clinical practice</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Файзрахманов</surname><given-names>Р. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Fayzrakhmanov</surname><given-names>R. R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д-р мед. наук, профессор Института усовершенствования врачей, зав. Центром офтальмотологии</p><p>105203, Москва, ул. Нижняя Первомайская, д. 70 </p></bio><bio xml:lang="en"><p>Dr. Med. Sci., Professor at Institute for Advanced Medical Training, Head of Center for ophthalmology</p><p>70, Nizhnyaya Pervomayskaya St., 105203, Moscow </p></bio><email xlink:type="simple">rinatrf@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБУ «Национальный медико-хирургический центр им. Н.И. Пирогова» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>N.I. Pirogov National Medical and Surgical Center</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>12</day><month>06</month><year>2019</year></pub-date><volume>12</volume><issue>2</issue><fpage>97</fpage><lpage>105</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Файзрахманов Р.Р., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Файзрахманов Р.Р.</copyright-holder><copyright-holder xml:lang="en">Fayzrakhmanov R.R.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://roj.igb.ru/jour/article/view/279">https://roj.igb.ru/jour/article/view/279</self-uri><abstract><p>Революционным направлением в лечении неоваскулярной возрастной макулярной дегенерации (нВМД) является антиангиогенная терапия, направленная на блокаду факторов роста новообразованных сосудов (VEGF). На данный момент для применения в офтальмологии зарегистрировано два анти-VEGF препарата, а поиск новых молекул лишь набирает обороты. В ходе изучения новых подходов к лечению и разработки инновационных препаратов современная медицина опирается на данные международных рандомизированных клинических исследований (РКИ). Подобный вектор научных интересов обоснован высокой степенью достоверности данных, получаемых в РКИ. Однако при анализе эффективности анти-VEGF терапии у пациентов с нВМД в реальной клинической практике (РКП) многие офтальмологи выявляют несоответствие ожидаемых (на основании РКИ) и получаемых «в жизни» морфофункциональных результатов. Вследствие этого важно отметить, что РКИ определяют должный идеал динамики морфофункциональных параметров, которого можно достичь лишь при правильном построении терапии в РКП. Результаты, получаемые в практике каждого специалиста, напрямую зависят от тщательности следования прописанным протоколам лечения, бремени лечения, а также потенциала самого лекарственного средства. В данном обзоре литературы представлен сравнительный анализ результатов применения анти-VEGF препаратов (ранибизумаба и афлиберцепта), полученных в ключевых РКИ, с исходами их применения в РКП по показанию нВМД.</p></abstract><trans-abstract xml:lang="en"><p>Antivasoproliferative therapy is a revolutionary trend in the treatment of neovascular age-related macular degeneration (nAMD), as it is aimed at blocking growth factors of the newly formed vessels. Currently, two anti-VEGF drugs are registered for ophthalmological use, and the search for new molecules is only gaining momentum. Studying new approaches to treatment and developing innovative drugs, modern medicine relies on the data from international randomized clinical trials (RCT). The fact that this direction attracts much scientific interest is explained by high reliability of the data obtained with RCTs. However, when analyzing the effectiveness of anti-VEGF therapy in patients with nAMD in routine clinical practice, many ophthalmologists are confronted with discrepancies between the expected morphological and functional results as predicted by RCTs and those obtained in reality. It is thus important to bear in mind that RCTs simply determine how the dynamics of morphofunctional parameters should look like, whilst the ideal result is only achievable through correct implementation of therapeutic strategy in real clinical practice. The results obtained in the practice of any specialist wholly depend on how carefully the prescribed treatment protocols are followed by doctors and patients, how burdensome the treatment is, as well as on the potential of the medication. This literary review offers a comparative analysis of the results achieved by using anti-VEGF drugs (ranibizumab and aflibercept) obtained in key RCTs and in routine clinical treatment of nAMD patients.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>неоваскулярная возрастная макулярная дегенерация</kwd><kwd>афлиберцепт</kwd><kwd>ранибизумаб</kwd><kwd>реальная клиническая практика</kwd></kwd-group><kwd-group xml:lang="en"><kwd>neovascular age-related macular degeneration</kwd><kwd>nAMD</kwd><kwd>aflibercept</kwd><kwd>ranibizumab</kwd><kwd>routine clinical practice</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Resnikoff S., Pascolini D., Mariottia S.P., Pokharel G.P. Global magnitude of visual impairment caused by uncorrected refractive errors in 2004. Bulletin of the World Health Organization. 2008; 86: 63–70. doi:10.2471/BLT.07.041210</mixed-citation><mixed-citation xml:lang="en">Resnikoff S., Pascolini D., Mariottia S.P., Pokharel G.P. Global magnitude of visual impairment caused by uncorrected refractive errors in 2004. Bulletin of the World Health Organization. 2008; 86: 63–70. doi:10.2471/BLT.07.041210</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Congdon N., O’Colmain B., Klaver C.C., et al. Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch. Ophthalmol. 2004; 122 (4): 477–85. doi: 10.1001/archopht.122.4.477</mixed-citation><mixed-citation xml:lang="en">Congdon N., O’Colmain B., Klaver C.C., et al. Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch. Ophthalmol. 2004; 122 (4): 477–85. doi: 10.1001/archopht.122.4.477</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">de Jong P.T.M. Age-related macular degeneration. N. Engl. J. Med. 2006; 355: 1474-85. doi: 10.1056/NEJMra062326</mixed-citation><mixed-citation xml:lang="en">de Jong P.T.M. Age-related macular degeneration. N. Engl. J. Med. 2006; 355: 1474-85. doi: 10.1056/NEJMra062326</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Ambati J., Fowler B.J. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12; 75 (1): 26–39. doi: 10.1016/j.neuron.2012.06.018</mixed-citation><mixed-citation xml:lang="en">Ambati J., Fowler B.J. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12; 75 (1): 26–39. doi: 10.1016/j.neuron.2012.06.018</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Lim L.S., Mitchell P., Seddon J.M., Holz F.G., Wong T.Y. Agerelated macular degeneration. Lancet. 2012; 379: 1728–38. doi: 10.1016/S0140-6736(12)60282-7</mixed-citation><mixed-citation xml:lang="en">Lim L.S., Mitchell P., Seddon J.M., Holz F.G., Wong T.Y. Agerelated macular degeneration. Lancet. 2012; 379: 1728–38. doi: 10.1016/S0140-6736(12)60282-7</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Soubrane G., Cruess A., Lotery A., et al. Burden and health care resource utilization in neovascular age-related macular degeneration: findings of a multicountry study. Arch Ophthalmol. 2007; 125 (9): 1249–54. doi: 10.1001/archopht.125.9.1249</mixed-citation><mixed-citation xml:lang="en">Soubrane G., Cruess A., Lotery A., et al. Burden and health care resource utilization in neovascular age-related macular degeneration: findings of a multicountry study. Arch Ophthalmol. 2007; 125 (9): 1249–54. doi: 10.1001/archopht.125.9.1249</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Harwood R.H. Visual problems and falls. Age and aging. 2001: 30 (S 4): 13–8.</mixed-citation><mixed-citation xml:lang="en">Harwood R.H. Visual problems and falls. Age and aging. 2001: 30 (S 4): 13–8.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">The Global Economic Cost of Visual Impairment. AMD Alliance International. 2010. Available at: http://www.sefap.it/economiasanitaria_news_201004/GLOBAL_COST_FINAL_SUMMARY.pdf</mixed-citation><mixed-citation xml:lang="en">The Global Economic Cost of Visual Impairment. AMD Alliance International. 2010. Available at: http://www.sefap.it/economiasanitaria_news_201004/GLOBAL_COST_FINAL_SUMMARY.pdf</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Wong W.L., Su X., Li X., et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob. Health. 2014; 2: e 106–16. doi: 10.1016/S2214-109X(13)70145-1</mixed-citation><mixed-citation xml:lang="en">Wong W.L., Su X., Li X., et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob. Health. 2014; 2: e 106–16. doi: 10.1016/S2214-109X(13)70145-1</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Colijn J.M., Buitendijk G.H.S., Prokofyeva E., et al. Prevalence of age-related macular degeneration in Europe. The Past and the Future. Ophthalmology. 2017; 124: 1753–63. doi: 10.1016/j.ophtha.2017.05.035</mixed-citation><mixed-citation xml:lang="en">Colijn J.M., Buitendijk G.H.S., Prokofyeva E., et al. Prevalence of age-related macular degeneration in Europe. The Past and the Future. Ophthalmology. 2017; 124: 1753–63. doi: 10.1016/j.ophtha.2017.05.035</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Файзрахманов Р.Р., Зайнуллин Р.М., Гильманшин Т.Р., Ярмухаметова А.Л. Картирование фовеолярной зоны сетчатки при идиопатическом макулярном разрыве. Вестник Оренбургского государственного университета. 2014; 13 (173): 322–4.</mixed-citation><mixed-citation xml:lang="en">Файзрахманов Р.Р., Зайнуллин Р.М., Гильманшин Т.Р., Ярмухаметова А.Л. Картирование фовеолярной зоны сетчатки при идиопатическом макулярном разрыве. Вестник Оренбургского государственного университета. 2014; 13 (173): 322–4.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Файзрахманов Р.Р., Каланов М.Р., Зайнуллин Р.М. Витрэктомия в сочетании с пилингом внутренней пограничной мембраны при диабетическом макулярном отеке. Вестник Оренбургского государственного университета. 2015; 12 (187): 257–9.</mixed-citation><mixed-citation xml:lang="en">Файзрахманов Р.Р., Каланов М.Р., Зайнуллин Р.М. Витрэктомия в сочетании с пилингом внутренней пограничной мембраны при диабетическом макулярном отеке. Вестник Оренбургского государственного университета. 2015; 12 (187): 257–9.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Охоцимская Т.Д., Зайцева О.В. Афлиберцепт в лечении заболеваний сетчатки. Обзор клинических исследований. Российский офтальмологический журнал. 2017; 10 (2): 103–11. https://doi.org/10.21516/2072-0076-2017-10-2-103-111</mixed-citation><mixed-citation xml:lang="en">Охоцимская Т.Д., Зайцева О.В. Афлиберцепт в лечении заболеваний сетчатки. Обзор клинических исследований. Российский офтальмологический журнал. 2017; 10 (2): 103–11. https://doi.org/10.21516/2072-0076-2017-10-2-103-111</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Зайцева О.В., Сарыгина О.И. Результаты долгосрочного наблюдения пациентов с возрастной макулярной дегенерацией на фоне приема лютеинсодержащего препарата. Российский офтальмологический журнал. 2016; 9 (2): 70–6. https://doi.org/10.21516/2072-0076-2016-9-2-70-76</mixed-citation><mixed-citation xml:lang="en">Зайцева О.В., Сарыгина О.И. Результаты долгосрочного наблюдения пациентов с возрастной макулярной дегенерацией на фоне приема лютеинсодержащего препарата. Российский офтальмологический журнал. 2016; 9 (2): 70–6. https://doi.org/10.21516/2072-0076-2016-9-2-70-76</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Файзрахманов Р.Р., Будзинская М.В. Макулярные пигменты при дегенеративных процессах сетчатки. Вестник офтальмологии. 2018; 134 (5): 135–40. doi: 10.17116/oftalma2018134051135</mixed-citation><mixed-citation xml:lang="en">Файзрахманов Р.Р., Будзинская М.В. Макулярные пигменты при дегенеративных процессах сетчатки. Вестник офтальмологии. 2018; 134 (5): 135–40. doi: 10.17116/oftalma2018134051135</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Клинические рекомендации: Возрастная макулярная дегенерация. Общероссийская общественная организация «Ассоциация врачей-офтальмологов». 2017. Доступно на: http://avo-portal.ru/doc/fkr/item/261-vozrastnaya-makulyarnayadegeneratsiya</mixed-citation><mixed-citation xml:lang="en">Клинические рекомендации: Возрастная макулярная дегенерация. Общероссийская общественная организация «Ассоциация врачей-офтальмологов». 2017. Доступно на: http://avo-portal.ru/doc/fkr/item/261-vozrastnaya-makulyarnayadegeneratsiya</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">NICE guideline. Age-related macular degeneration. 2018. Available at: https://www.nice.org.uk/guidance/ng82</mixed-citation><mixed-citation xml:lang="en">NICE guideline. Age-related macular degeneration. 2018. Available at: https://www.nice.org.uk/guidance/ng82</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Нероев В.В. Российское наблюдательное эпидемиологическое неинтервенционное исследование пациентов с влажной формой возрастной макулярной дегенерации. Российский офтальмологический журнал, 2011; 2: 4–9.</mixed-citation><mixed-citation xml:lang="en">Нероев В.В. Российское наблюдательное эпидемиологическое неинтервенционное исследование пациентов с влажной формой возрастной макулярной дегенерации. Российский офтальмологический журнал, 2011; 2: 4–9.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Файзрахманов Р.Р., Ярмухаметова А.Л., Гильманшин Т.Р. Функциональные показатели зрения после удаления фиброваскулярных мембран. Вестник Волгоградского государственного медицинского университета. 2013; 48 (4): 171–3.</mixed-citation><mixed-citation xml:lang="en">Файзрахманов Р.Р., Ярмухаметова А.Л., Гильманшин Т.Р. Функциональные показатели зрения после удаления фиброваскулярных мембран. Вестник Волгоградского государственного медицинского университета. 2013; 48 (4): 171–3.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Wolf S. Current status of anti-vascular endothelial growth factor therapy in Europe. Jpn. J. Ophthalmol. 2008; 52: 433–9. doi: 10.1007/s10384-008-0580-4</mixed-citation><mixed-citation xml:lang="en">Wolf S. Current status of anti-vascular endothelial growth factor therapy in Europe. Jpn. J. Ophthalmol. 2008; 52: 433–9. doi: 10.1007/s10384-008-0580-4</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Cruess A.F., Berger A., Colleaux K., et al. Canadian expert consensus: optimal treatment of neovascular age-related macular degeneration. Can. J .Ophthalmol. 2012; 47 (3 Jun.): 227–35. doi: 10.1016/j.jcjo.2012.03.007</mixed-citation><mixed-citation xml:lang="en">Cruess A.F., Berger A., Colleaux K., et al. Canadian expert consensus: optimal treatment of neovascular age-related macular degeneration. Can. J .Ophthalmol. 2012; 47 (3 Jun.): 227–35. doi: 10.1016/j.jcjo.2012.03.007</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">Rosenfeld P.J., Brown D.M., Heier J.S., et al. MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N. Engl. J. Med. 2006; 355(14): 1419-31. doi: 10.1056/NEJMoa054481</mixed-citation><mixed-citation xml:lang="en">Rosenfeld P.J., Brown D.M., Heier J.S., et al. MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N. Engl. J. Med. 2006; 355(14): 1419-31. doi: 10.1056/NEJMoa054481</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">Brown D.M., Kaiser P.K., Michels M., et al. ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N. Engl. J. Med. 2006; 355 (14): 1432–44. doi: 10.1056/NEJMoa062655</mixed-citation><mixed-citation xml:lang="en">Brown D.M., Kaiser P.K., Michels M., et al. ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N. Engl. J. Med. 2006; 355 (14): 1432–44. doi: 10.1056/NEJMoa062655</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">Antoszyk A.N., Tuomi L., Chung C.Y., Singh A. Ranibizumab combined with Verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): Year 2 Results. Am. J. Ophthalmol. 2008; 145: 862–74. doi: 10.1016/j.ajo.2007.12.029</mixed-citation><mixed-citation xml:lang="en">Antoszyk A.N., Tuomi L., Chung C.Y., Singh A. Ranibizumab combined with Verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): Year 2 Results. Am. J. Ophthalmol. 2008; 145: 862–74. doi: 10.1016/j.ajo.2007.12.029</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">Barrow P.C. Teratogenicity testing. Methods and protocols. Springer Science, Business Media; LLC. 2013. doi: 10.1007/978-1-62703-131-8</mixed-citation><mixed-citation xml:lang="en">Barrow P.C. Teratogenicity testing. Methods and protocols. Springer Science, Business Media; LLC. 2013. doi: 10.1007/978-1-62703-131-8</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Mentz R.J., Hernandez A.F., Berdan L.G., et al. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation. 2016; 133 (9): 872–80. doi: 10.1161/CIRCULATIONAHA.115.019902</mixed-citation><mixed-citation xml:lang="en">Mentz R.J., Hernandez A.F., Berdan L.G., et al. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation. 2016; 133 (9): 872–80. doi: 10.1161/CIRCULATIONAHA.115.019902</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">Мелихов О.Г. Клинические исследования. 3-е изд., доп. Москва: Атмосфера; 2013.</mixed-citation><mixed-citation xml:lang="en">Мелихов О.Г. Клинические исследования. 3-е изд., доп. Москва: Атмосфера; 2013.</mixed-citation></citation-alternatives></ref><ref id="cit28"><label>28</label><citation-alternatives><mixed-citation xml:lang="ru">Talks J., Daien V., Finger R.P. Utility of real-world evidence for evaluating anti–vascular endothelial growth factor treatment of neovascular age-related macular degeneration. Survey of Ophthalmology. 2019; Feb. 21: pii: S0039-6257 (17): 30337–5. doi: 10.1016/j.survophthal.2019.02.008</mixed-citation><mixed-citation xml:lang="en">Talks J., Daien V., Finger R.P. Utility of real-world evidence for evaluating anti–vascular endothelial growth factor treatment of neovascular age-related macular degeneration. Survey of Ophthalmology. 2019; Feb. 21: pii: S0039-6257 (17): 30337–5. doi: 10.1016/j.survophthal.2019.02.008</mixed-citation></citation-alternatives></ref><ref id="cit29"><label>29</label><citation-alternatives><mixed-citation xml:lang="ru">Friedman L., Furberg C., DeMets D. Fundamentals of Clinical Trials. 4th ed. Springer. 2010.</mixed-citation><mixed-citation xml:lang="en">Friedman L., Furberg C., DeMets D. Fundamentals of Clinical Trials. 4th ed. Springer. 2010.</mixed-citation></citation-alternatives></ref><ref id="cit30"><label>30</label><citation-alternatives><mixed-citation xml:lang="ru">Saturni S., Bellini F., Braido F. Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view. Pulm. Pharmacol. Ther. 2014; 27 (2): 129–38. doi:10.1016/j.pupt.2014.01.005</mixed-citation><mixed-citation xml:lang="en">Saturni S., Bellini F., Braido F. Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view. Pulm. Pharmacol. Ther. 2014; 27 (2): 129–38. doi:10.1016/j.pupt.2014.01.005</mixed-citation></citation-alternatives></ref><ref id="cit31"><label>31</label><citation-alternatives><mixed-citation xml:lang="ru">Singal A.G., Higgins P.D., Waljee A.K. A primer on effectiveness and efficacy trials. Clinical and translational gastroenterology. Clin. Transl. Gastroenterol. 2014; 2 (5): e45. doi: 10.1038/ctg.2013.13</mixed-citation><mixed-citation xml:lang="en">Singal A.G., Higgins P.D., Waljee A.K. A primer on effectiveness and efficacy trials. Clinical and translational gastroenterology. Clin. Transl. Gastroenterol. 2014; 2 (5): e45. doi: 10.1038/ctg.2013.13</mixed-citation></citation-alternatives></ref><ref id="cit32"><label>32</label><citation-alternatives><mixed-citation xml:lang="ru">Brown D.M., Michels M., Kaiser P.K., et al. Ranibizumab versus Verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009; 116 : 57–65. doi: 10.1016/j.ophtha.2008.10.018</mixed-citation><mixed-citation xml:lang="en">Brown D.M., Michels M., Kaiser P.K., et al. Ranibizumab versus Verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009; 116 : 57–65. doi: 10.1016/j.ophtha.2008.10.018</mixed-citation></citation-alternatives></ref><ref id="cit33"><label>33</label><citation-alternatives><mixed-citation xml:lang="ru">Singer M.A., Awh C.C., Sadda S., et al. HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology. 2012; 119 (6 Jun.): 1175–83. doi: 10.1016/j.ophtha.2011.12.016</mixed-citation><mixed-citation xml:lang="en">Singer M.A., Awh C.C., Sadda S., et al. HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology. 2012; 119 (6 Jun.): 1175–83. doi: 10.1016/j.ophtha.2011.12.016</mixed-citation></citation-alternatives></ref><ref id="cit34"><label>34</label><citation-alternatives><mixed-citation xml:lang="ru">Файзрахманов Р.Р. Режимы назначения анти-VEGFпрепаратов при терапии неоваскулярной возрастной макулярной дегенерации. Вестник офтальмологии. 2018; 6: 107- 15. doi: 10.17116/oftalma2018134061107</mixed-citation><mixed-citation xml:lang="en">Файзрахманов Р.Р. Режимы назначения анти-VEGFпрепаратов при терапии неоваскулярной возрастной макулярной дегенерации. Вестник офтальмологии. 2018; 6: 107- 15. doi: 10.17116/oftalma2018134061107</mixed-citation></citation-alternatives></ref><ref id="cit35"><label>35</label><citation-alternatives><mixed-citation xml:lang="ru">Heier J.S., Brown D.M., Chong V., et al. Intravitreal Aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012; 119 (12): 2537–48. doi: 10.1016/j.ophtha.2012.09.006</mixed-citation><mixed-citation xml:lang="en">Heier J.S., Brown D.M., Chong V., et al. Intravitreal Aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012; 119 (12): 2537–48. doi: 10.1016/j.ophtha.2012.09.006</mixed-citation></citation-alternatives></ref><ref id="cit36"><label>36</label><citation-alternatives><mixed-citation xml:lang="ru">Schmidt-Erfurth U., Kaiser P.K., Korobelnik J.-F. Intravitreal Aflibercept injection for neovascular age-related macular degeneration. Ninety-six weeks results of the VIEW studies. Ophthalmology. 2014; 121: 193–201. doi: 10.1016/j.ophtha.2013.08.011</mixed-citation><mixed-citation xml:lang="en">Schmidt-Erfurth U., Kaiser P.K., Korobelnik J.-F. Intravitreal Aflibercept injection for neovascular age-related macular degeneration. Ninety-six weeks results of the VIEW studies. Ophthalmology. 2014; 121: 193–201. doi: 10.1016/j.ophtha.2013.08.011</mixed-citation></citation-alternatives></ref><ref id="cit37"><label>37</label><citation-alternatives><mixed-citation xml:lang="ru">Uttam B., Anto V.K., Arun G., Rituraj M., Behsad Z. Evidence-Based Studies – their advantages and disadvantages in the Data Collection Ecosystem. 2016; 1 (2): 6. doi: 10.21767/2572-5610.100006</mixed-citation><mixed-citation xml:lang="en">Uttam B., Anto V.K., Arun G., Rituraj M., Behsad Z. Evidence-Based Studies – their advantages and disadvantages in the Data Collection Ecosystem. 2016; 1 (2): 6. doi: 10.21767/2572-5610.100006</mixed-citation></citation-alternatives></ref><ref id="cit38"><label>38</label><citation-alternatives><mixed-citation xml:lang="ru">FDA. U.S. Department of Health and Human Services. Use of real-world evidence to support regulatory decision-making for medical devices. Guidance for Industry and Food and Drug Administration Staff. 2017. Available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf</mixed-citation><mixed-citation xml:lang="en">FDA. U.S. Department of Health and Human Services. Use of real-world evidence to support regulatory decision-making for medical devices. Guidance for Industry and Food and Drug Administration Staff. 2017. Available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf</mixed-citation></citation-alternatives></ref><ref id="cit39"><label>39</label><citation-alternatives><mixed-citation xml:lang="ru">Sherman R.E., Anderson S.A., Pan G.J.D., et al. Real-World Evidence — what is it and what can it tell us? N. Engl. J. Med. 2016; 375 (23): 2293–7. doi: 10.1056/NEJMsb1609216</mixed-citation><mixed-citation xml:lang="en">Sherman R.E., Anderson S.A., Pan G.J.D., et al. Real-World Evidence — what is it and what can it tell us? N. Engl. J. Med. 2016; 375 (23): 2293–7. doi: 10.1056/NEJMsb1609216</mixed-citation></citation-alternatives></ref><ref id="cit40"><label>40</label><citation-alternatives><mixed-citation xml:lang="ru">Chong V. Ranibizumab for the treatment of wet AMD: a summary of real-world studies. Eye (Lond). 2016; 30(2): 270-86. doi: 10.1038/eye.2015.217</mixed-citation><mixed-citation xml:lang="en">Chong V. Ranibizumab for the treatment of wet AMD: a summary of real-world studies. Eye (Lond). 2016; 30(2): 270-86. doi: 10.1038/eye.2015.217</mixed-citation></citation-alternatives></ref><ref id="cit41"><label>41</label><citation-alternatives><mixed-citation xml:lang="ru">Lee A.Y., Lee C.S., Egan C.A., et al. UK AMD/DR EMR REPORT IX: comparative effectiveness of predominantly as needed (PRN) ranibizumab versus continuous aflibercept in UK clinical practice. Br. J. Ophthalmol. 2017; 101 (12 Dec.): 1683–88. doi: 10.1136/bjophthalmol-2016-309818</mixed-citation><mixed-citation xml:lang="en">Lee A.Y., Lee C.S., Egan C.A., et al. UK AMD/DR EMR REPORT IX: comparative effectiveness of predominantly as needed (PRN) ranibizumab versus continuous aflibercept in UK clinical practice. Br. J. Ophthalmol. 2017; 101 (12 Dec.): 1683–88. doi: 10.1136/bjophthalmol-2016-309818</mixed-citation></citation-alternatives></ref><ref id="cit42"><label>42</label><citation-alternatives><mixed-citation xml:lang="ru">Holz F.G., Tadayoni R., Beatty S., et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br. J. Ophthalmol. 2015; 99 (2): 220–6. doi: 10.1136/bjophthalmol-2014-305327</mixed-citation><mixed-citation xml:lang="en">Holz F.G., Tadayoni R., Beatty S., et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br. J. Ophthalmol. 2015; 99 (2): 220–6. doi: 10.1136/bjophthalmol-2014-305327</mixed-citation></citation-alternatives></ref><ref id="cit43"><label>43</label><citation-alternatives><mixed-citation xml:lang="ru">Wolf A., Kampik A. Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health services research. Graefes Arch. Clin. Exp. Ophthalmol. 2014; 252 (4): 647–55. doi: 10.1007/s00417-013-2562-6</mixed-citation><mixed-citation xml:lang="en">Wolf A., Kampik A. Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health services research. Graefes Arch. Clin. Exp. Ophthalmol. 2014; 252 (4): 647–55. doi: 10.1007/s00417-013-2562-6</mixed-citation></citation-alternatives></ref><ref id="cit44"><label>44</label><citation-alternatives><mixed-citation xml:lang="ru">Lanzetta P., Loewenstein A. Vision Academy Steering Committee. Fundamental principles of an anti-VEGF treatment regimen: optimal application of intravitreal anti-vascular endothelial growth factor therapy of macular diseases. Graefes Arch. Clin. Exp. Ophthalmol. 2017; 255 (7 Jul.): 1259–73. doi: 10.1007/s00417-017-3647-4</mixed-citation><mixed-citation xml:lang="en">Lanzetta P., Loewenstein A. Vision Academy Steering Committee. Fundamental principles of an anti-VEGF treatment regimen: optimal application of intravitreal anti-vascular endothelial growth factor therapy of macular diseases. Graefes Arch. Clin. Exp. Ophthalmol. 2017; 255 (7 Jul.): 1259–73. doi: 10.1007/s00417-017-3647-4</mixed-citation></citation-alternatives></ref><ref id="cit45"><label>45</label><citation-alternatives><mixed-citation xml:lang="ru">Weber M., Velasque L., Coscas F., et al. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmology. 2019; 4: e000109. doi: 10.1136/bmjophth-2017-000109</mixed-citation><mixed-citation xml:lang="en">Weber M., Velasque L., Coscas F., et al. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmology. 2019; 4: e000109. doi: 10.1136/bmjophth-2017-000109</mixed-citation></citation-alternatives></ref><ref id="cit46"><label>46</label><citation-alternatives><mixed-citation xml:lang="ru">Framme C., Eter N., Hamache T., et al. Aflibercept for Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice in Germany. Twelve-Month Outcomes of PERSEUS. Ophthalmology Retina 2018; 2: 539-549. doi:10.1016/j.oret.2017.09.017</mixed-citation><mixed-citation xml:lang="en">Framme C., Eter N., Hamache T., et al. Aflibercept for Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice in Germany. Twelve-Month Outcomes of PERSEUS. Ophthalmology Retina 2018; 2: 539-549. doi:10.1016/j.oret.2017.09.017</mixed-citation></citation-alternatives></ref><ref id="cit47"><label>47</label><citation-alternatives><mixed-citation xml:lang="ru">Epstein D., Amrén U. Near vision outcome in patients with agerelated macular degeneration treated with aflibercept. Retina. 2016; 36 (9): 1773–7. doi: 10.1097/IAE.0000000000000978</mixed-citation><mixed-citation xml:lang="en">Epstein D., Amrén U. Near vision outcome in patients with agerelated macular degeneration treated with aflibercept. Retina. 2016; 36 (9): 1773–7. doi: 10.1097/IAE.0000000000000978</mixed-citation></citation-alternatives></ref><ref id="cit48"><label>48</label><citation-alternatives><mixed-citation xml:lang="ru">Eleftheriadou M., Vazquez-Alfageme C., Citu C.M., et al. Long-term outcomes of Aflibercept treatment for neovascular age-related macular degeneration in a clinical setting. Am. J. of Ophthalmol. 2017; 174: 160–8. doi: 10.1016/j.ajo.2016.09.038</mixed-citation><mixed-citation xml:lang="en">Eleftheriadou M., Vazquez-Alfageme C., Citu C.M., et al. Long-term outcomes of Aflibercept treatment for neovascular age-related macular degeneration in a clinical setting. Am. J. of Ophthalmol. 2017; 174: 160–8. doi: 10.1016/j.ajo.2016.09.038</mixed-citation></citation-alternatives></ref><ref id="cit49"><label>49</label><citation-alternatives><mixed-citation xml:lang="ru">Almuhtaseb H., Kanavati S., Rufai S.R., Lotery A.J. One-year realworld outcomes in patients receiving fixed-dosing aflibercept for neovascular age-related macular degeneration. Eye (Lond). 2017; 31 (6): 878–83. doi: 10.1038/eye.2017.6</mixed-citation><mixed-citation xml:lang="en">Almuhtaseb H., Kanavati S., Rufai S.R., Lotery A.J. One-year realworld outcomes in patients receiving fixed-dosing aflibercept for neovascular age-related macular degeneration. Eye (Lond). 2017; 31 (6): 878–83. doi: 10.1038/eye.2017.6</mixed-citation></citation-alternatives></ref><ref id="cit50"><label>50</label><citation-alternatives><mixed-citation xml:lang="ru">Sachs H., Keramas G., Framme C. Importance of regular treatment in nAMD: 12-month post-hoc analysis of the PERSEUS study with intravitreal aflibercept injections. COPHyEU. 2018.</mixed-citation><mixed-citation xml:lang="en">Sachs H., Keramas G., Framme C. Importance of regular treatment in nAMD: 12-month post-hoc analysis of the PERSEUS study with intravitreal aflibercept injections. COPHyEU. 2018.</mixed-citation></citation-alternatives></ref><ref id="cit51"><label>51</label><citation-alternatives><mixed-citation xml:lang="ru">Framme C., Eter N., Thomas H., et al. Aflibercept for patients with neovascular age-related macular degeneration in routine clinical practice in Germany: Twelve-month outcomes of PERSEUS. Ophthalmology. Retina 2018; 2: 539–49. doi: https://doi.org/10.1016/j.ophtha.2018.05.007</mixed-citation><mixed-citation xml:lang="en">Framme C., Eter N., Thomas H., et al. Aflibercept for patients with neovascular age-related macular degeneration in routine clinical practice in Germany: Twelve-month outcomes of PERSEUS. Ophthalmology. Retina 2018; 2: 539–49. doi: https://doi.org/10.1016/j.ophtha.2018.05.007</mixed-citation></citation-alternatives></ref><ref id="cit52"><label>52</label><citation-alternatives><mixed-citation xml:lang="ru">Fauser S., Muether P.S. Clinical correlation to differences in ranibizumab and aflibercept vascular endothelial growth factor suppression times. Br. J. Ophthalmol. 2016; 100 (11 Nov.): 1494–8. doi:10.1136/bjophthalmol-2015-308264</mixed-citation><mixed-citation xml:lang="en">Fauser S., Muether P.S. Clinical correlation to differences in ranibizumab and aflibercept vascular endothelial growth factor suppression times. Br. J. Ophthalmol. 2016; 100 (11 Nov.): 1494–8. doi:10.1136/bjophthalmol-2015-308264</mixed-citation></citation-alternatives></ref><ref id="cit53"><label>53</label><citation-alternatives><mixed-citation xml:lang="ru">Fauser S., Schwabecker V., Muether P. Suppression of intraocular vascular endothelial growth factor during aflibercept treatment of age-related macular degeneration. American Journal of Ophthalmology. 2014; 158 (3): 532–6. doi:10.1016/j.ajo.2014.05.025</mixed-citation><mixed-citation xml:lang="en">Fauser S., Schwabecker V., Muether P. Suppression of intraocular vascular endothelial growth factor during aflibercept treatment of age-related macular degeneration. American Journal of Ophthalmology. 2014; 158 (3): 532–6. doi:10.1016/j.ajo.2014.05.025</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
