RU2017119647A - Способ лечения болезней глаз - Google Patents
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Claims (29)
1. Способ лечения неоваскулярной возрастной макулярной дегенерации (нВМД) у млекопитающего, где способ включает:
a) введение млекопитающему трех отдельных доз антагониста VEGF с четырехнедельными интервалами;
b) оценку млекопитающего на предмет максимальной остроты зрения с коррекцией (BCVA), остроты зрения (VA), толщины центрального подполя (CSFT) и наличия интраретинальных кист/жидкости на 12 неделе;
c) наличие интраретинальных кист/жидкости на 16 неделе; и
d) введение млекопитающему дополнительной дозы антагониста VEGF один раз каждые 8 недель (режим q8), если имеется соответствие следующим критериям, и каждые 12 недель (режим q12), если соответствие следующим критериям отсутствует:
a) снижение показателя BCVA на ≥5 букв по причине активности нВМД на 16 неделе по сравнению с исходным показателем,
b) снижение показателя BCVA на ≥5 букв по причине активности нВМД на 16 Неделе по сравнению с 12 неделей,
c) снижение показателя VA на ≥3 букв и повышение показателя CSFT ≥75мкм на 16 неделе по сравнению с 12 неделей, и
d) появление новых или ухудшение состояния имевшихся интраретинальных кист (IRC)/интраретинальной жидкости (IRF) на 16 неделе по сравнению с 12 неделей.
2. Способ по п. 1, дополнительно включающий оценку млекопитающего, выбранного для режима q12 на 20, 32 и 44 неделе, в отношении BCVA, а также введение млекопитающим, отобранным для режима q8 после дополнительной оценки, если показатель BCVA составляет ≥5 букв по причине активности нВМД по сравнению с 12 неделей.
3. Способ по п. 1, дополнительно включающий оценку млекопитающего, выбранного для режима q8 на 20, 32 и 48 неделе, в отношении BCVA и наличия интраретинальных кист/жидкости (IRC/IRF), и введение млекопитающим дополнительных доз антагониста VEGF каждые 12 недель после оценки на 48 неделе, если отсутствует снижение показателя BCVA на ≥5 букв по причине активности нВМД на 48 неделе по сравнению с 32 неделей, и при отсутствии новых или ухудшения состояния имевшихся IRC/IRF на 48 неделе по сравнению с 32 Неделей.
4. Способ по п. 1, где млекопитающее представляет собой человека.
5. Способ по п. 1, где антагонист VEGF представляет собой анти-VEGF антитело.
6. Способ по п. 5, где анти-VEGF антитело включает последовательность SEQ ID NO: 3.
7. Способ по п. 1, где антагонист VEGF вводят при помощи интравитреальной инъекции.
8. Способ лечения неоваскулярной ВМД (нВМД), включающий введение млекопитающему трех отдельных доз антагониста VEGF с четырехнедельными интервалами, с последующем введением дополнительных доз каждые 12 недель (q12) и/или каждые 8 недель (q8) в зависимости от результатов оценки активности заболевания, проводимых при помощи заранее установленных визуальных и анатомических критериев, как оценивают на 12, 16, 29, 32 и 44 Неделях после введения первой отдельной дозы.
9. Способ по п. 8, где дополнительные оценки проводят на 48, 56, 68 и 80 неделях.
10. Способ по п. 8, где оценка активности заболевания включает оценку BCVA, VA, толщины центрального подполя (CSFT) и/или наличие интраретинальных кист/жидкости (IRC/IRF).
11. Способ по п. 10, где млекопитающее получает лечение каждые 8 недель (q8) при соответствии следующим критериям, и каждые 12 недель (q12) при отсутствии соответствия следующим критериям:
a) снижение показателя BCVA на ≥5 букв по причине активности нВМД на 16 неделе по сравнению с исходным показателем,
b) снижение показателя BCVA на ≥5 букв по причине активности нВМД на 16 неделе по сравнению с 1 неделей,
c) Снижение показателя VA на ≥3 букв и повышение показателя CSFT ≥75мкм на 16 неделе по сравнению с 12 неделей, и
d) Появление новых или ухудшение состояния имевшихся интраретинальных кист (IRC)/интраретинальной жидкости (IRF) на 16 неделе по сравнению с 12 неделей,
12. Способ по п. 11, дополнительно включающий оценку млекопитающего, выбранного для режима q12 на 20, 32 и 44 неделях, на основании BCVA, и введение млекопитающим, отобранным для режима q8 после дополнительной оценки в случае, если показатель BCVA составляет ≥5 букв по причине активности нВМД по сравнению с 12 Неделей.
13. Способ по п. 11, дополнительно включающий оценку млекопитающего, отобранного для режима q8 на 20, 32 и 48 неделях, на основании BCVA и наличия интраретинальных кист/жидкости (IRC/IRF), и введение млекопитающим дополнительных доз антагониста VEGF каждые 12 недель после оценки на 48 неделе, если отсутствует снижение показателя BCVA ≥5 букв по причине активности нВМД на 48 неделе по сравнению с 32 неделей, и если отсутствует появление новых или ухудшение состояния имевшихся IRC/IRF на 48 неделе по сравнению с 32 неделей.
14. Способ по п. 8, где млекопитающее представляет собой человека.
15. Способ по п. 8, где антагонист VEGF представляет собой анти-VEGF антитело.
16. Способ по п. 15, где анти-VEGF антитело включает последовательность SEQ ID NO: 3.
17. Способ по п. 8, где антагонист VEGF вводят при помощи интравитреальной инъекции.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462076770P | 2014-11-07 | 2014-11-07 | |
| US62/076,770 | 2014-11-07 | ||
| US201462088061P | 2014-12-05 | 2014-12-05 | |
| US62/088,061 | 2014-12-05 | ||
| PCT/US2015/059575 WO2016073918A1 (en) | 2014-11-07 | 2015-11-06 | Methods for treating ocular diseases |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2020114917A Division RU2771900C2 (ru) | 2014-11-07 | 2015-11-06 | Способ лечения болезней глаз |
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| RU2017119647A true RU2017119647A (ru) | 2018-12-07 |
| RU2017119647A3 RU2017119647A3 (ru) | 2019-05-29 |
| RU2722643C2 RU2722643C2 (ru) | 2020-06-02 |
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| US (5) | US10035850B2 (ru) |
| EP (3) | EP4684797A2 (ru) |
| JP (6) | JP6667519B2 (ru) |
| KR (4) | KR102588846B1 (ru) |
| CN (4) | CN114081951A (ru) |
| AU (6) | AU2015342815B2 (ru) |
| BR (2) | BR112017008093A2 (ru) |
| CA (1) | CA2966646A1 (ru) |
| CL (2) | CL2017001115A1 (ru) |
| CO (1) | CO2017004596A2 (ru) |
| EA (1) | EA201790989A1 (ru) |
| EC (1) | ECSP17034829A (ru) |
| ES (1) | ES3051145T3 (ru) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP2004697A2 (en) | 2006-04-07 | 2008-12-24 | The Procter & Gamble Company | Antibodies that bind human protein tyrosine phosphatase beta (hptpbeta) and uses thereof |
| US7622593B2 (en) | 2006-06-27 | 2009-11-24 | The Procter & Gamble Company | Human protein tyrosine phosphatase inhibitors and methods of use |
| CN102076716A (zh) | 2008-06-25 | 2011-05-25 | 艾斯巴技术,爱尔康生物医药研究装置有限责任公司 | 抑制TNFα的稳定和可溶的抗体 |
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