Tomita Mami, Yamamoto Manabu, Hirayama Kumiko, Kyo Akika, Misawa Norihiko, Kinari Gen, Kohno Takeya, Honda Shigeru
Department of Ophthalmology and Visual Science, Graduate School of Medicine, Osaka Metropolitan University, Osaka 545-8585, Japan.
J Clin Med. 2024 Aug 8;13(16):4641. doi: 10.3390/jcm13164641.
To evaluate the one-year outcomes of intravitreal ranibizumab biosimilar (RBZ-BS) injections for myopic choroidal neovascularization (mCNV) in Japanese patients. Twenty-one patients (mean age 69.0 years; 4 males, 17 females) with high myopia and mCNV were retrospectively reviewed. Twelve were treatment-naïve, and nine had previous anti-VEGF treatments. Efficacy measures included best-corrected visual acuity (BCVA) and central macular thickness (CMT). The treatment-naïve group showed significant BCVA improvement from 0.55 ± 0.34 at baseline to 0.24 ± 0.28 at 12 months. The previously treated group had no significant BCVA changes. CMT significantly decreased in both groups: from 295.3 ± 105.2 µm to 207.3 ± 63.0 µm in the treatment-naïve group, and from 196.1 ± 62.0 µm to 147.2 ± 50.1 µm in the previously treated group. Dry macula rates were high: 83% at 3 months and 83% at 12 months in the treatment-naïve group, and 67% at 3 months and 89% at 12 months in the previously treated group. No adverse events were reported. These findings indicate that RBZ-BS is an effective and safe treatment for mCNV, particularly in treatment-naïve patients. The use of RBZ-BS offers a cost-effective alternative to original ranibizumab, reducing financial burdens while maintaining high therapeutic efficacy. Further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and evaluate long-term outcomes and cost-effectiveness.
评估玻璃体内注射雷珠单抗生物类似药（RBZ-BS）治疗日本患者近视性脉络膜新生血管（mCNV）的一年期疗效。回顾性分析了21例高度近视合并mCNV的患者（平均年龄69.0岁；男性4例，女性17例）。其中12例为初治患者，9例曾接受过抗VEGF治疗。疗效指标包括最佳矫正视力（BCVA）和中心黄斑厚度（CMT）。初治组的BCVA从基线时的0.55±0.34显著提高至12个月时的0.24±0.28。既往治疗组的BCVA无显著变化。两组的CMT均显著降低：初治组从295.3±105.2µm降至207.3±63.0µm，既往治疗组从196.1±62.0µm降至147.2±50.1µm。黄斑干性病变发生率较高：初治组3个月时为83%，12个月时为83%；既往治疗组3个月时为67%，12个月时为89%。未报告不良事件。这些发现表明，RBZ-BS是治疗mCNV的一种有效且安全的方法，尤其适用于初治患者。使用RBZ-BS可提供一种比原研雷珠单抗更具成本效益的替代方案，在维持高治疗效果的同时减轻经济负担。需要进行更大样本量和更长随访期的进一步研究，以证实这些结果并评估长期疗效和成本效益。
