Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan.
Ube-Kohsan Central Hospital, Ube, Japan.
Graefes Arch Clin Exp Ophthalmol. 2020 Aug;258(8):1663-1670. doi: 10.1007/s00417-020-04745-1. Epub 2020 May 21.
To evaluate the advantages of the Trinity regimen for treatment-naïve neovascular age-related macular degeneration (nAMD).
Thirty-one treatment-naïve nAMD eyes were treated using the Trinity regimen with an intravitreal aflibercept injection (IVA) and evaluated after 24 months. Three treatment methods, pro re nata (PRN), treat and extend (TAE), and fixed regimen were changed depending on recurrence frequency. After the initial treatment, PRN or TAE (started for 4 or 8 weeks) was selected as per the recurrence interval. Subsequently, the recurrence interval became constant, transitioning from a TAE to fixed regimen. When the recurrence frequency became irregular, the treatment regimen was changed to TAE.
After the initial treatment, 15 eyes (48.4%) were allocated to the PRN group, 12 (38.7%) to the TAE 8-week group, and 4 (12.9%) to the TAE 4-week group. Mean logMAR significantly improved in all cases, 0.53 ± 0.40 at baseline to 0.36 ± 0.34 at 24 months (p < 0.01), in the PRN group (0.63 ± 0.46 to 0.42 ± 0.43, p < 0.01), and the TAE 8-week group (0.44 ± 0.29 to 0.27 ± 0.19, p < 0.05). LogMAR in the TAE 4-week group was maintained. The mean number of injections for all and in the PRN, TAE 8-week, and TAE 4-week groups were 9.7, 5.3, 13.1, and 15.8, respectively, with the PRN group being significantly less (p < 0.01).
The Trinity regimen delivered the benefits of the PRN, TAE, and FIXED regimens while minimizing injections during the early treatment phase without visual loss.
This trial was registered with the University Hospital Medical Information Network (UMIN ID: 000038335).
评估 Trinity 方案治疗初治性新生血管性年龄相关性黄斑变性(nAMD)的优势。
31 例初治性 nAMD 眼采用玻璃体腔内注射阿柏西普(IVA)的 Trinity 方案进行治疗,并在 24 个月后进行评估。根据复发频率,三种治疗方法(即按需治疗、治疗-扩展和固定方案)会进行转换。初始治疗后,根据复发间隔选择 PRN 或 TAE(开始治疗 4 或 8 周)。随后,将复发间隔固定,从 TAE 转为固定方案。当复发频率变得不规则时,将治疗方案改为 TAE。
初始治疗后,15 只眼(48.4%)被分配到 PRN 组,12 只眼(38.7%)被分配到 TAE 8 周组,4 只眼(12.9%)被分配到 TAE 4 周组。所有病例的平均 logMAR 均显著改善,从基线时的 0.53 ± 0.40 改善至 24 个月时的 0.36 ± 0.34(p < 0.01),PRN 组(0.63 ± 0.46 至 0.42 ± 0.43,p < 0.01)和 TAE 8 周组(0.44 ± 0.29 至 0.27 ± 0.19,p < 0.05)。TAE 4 周组的 logMAR 保持不变。所有患者和 PRN、TAE 8 周和 TAE 4 周组的平均注射次数分别为 9.7、5.3、13.1 和 15.8,PRN 组显著较少(p < 0.01)。
Trinity 方案在早期治疗阶段既避免了视力丧失,又减少了注射次数,同时兼具 PRN、TAE 和 FIXED 方案的优势。
本试验在大学医院医学信息网络(UMIN ID:000038335)注册。