Traumatic Optic Neuropathy Treatment Trial 2 (TONTT-2): evaluating the efficacy of different doses of erythropoietin – a multicentre, randomised, double-blind clinical trial

IF 3.7 2区医学 Q1 OPHTHALMOLOGY

British Journal of Ophthalmology Pub Date : 2024-10-26 DOI:10.1136/bjo-2024-325828

Parya Abdolalizadeh, Mohsen Bahmani Kashkouli, Mahya Ghazizadeh, Farzad Pakdel, Mohammad Etezad Razavi, Marzieh Nojomi, Kaveh Abri Aghdam, Mostafa Soltan Sanjari, Nasser Karimi, Hossein Ghahvehchian, Mohammad Soleimani, Seyed Ali Tabatabaei

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引用次数: 0

Abstract

Aim The aim is to compare the efficacy and safety of three different weight-adjusted intravenous erythropoietin (EPO) doses in patients with indirect traumatic optic neuropathy (TON). Methods This study is a multicentre, randomised, parallel-group, double-blind, dose-finding trial on patients aged ≥7 years with a confirmed diagnosis of indirect TON in ≤3 weeks. The trial had a 3-day treatment period and a 3-month follow-up period. Patients were randomly allocated (1:1:1) to receive EPO at doses of 900 IU/kg (300 IU/kg/day), 1800 IU/kg (600 IU/kg/day) or 3600 IU/kg (600 IU/kg/day on presentation and then 1 month later) EPO. The changes in the best-corrected visual acuity (BCVA), colour vision and relative afferent pupillary defect (RAPD) were assessed. Results Out of 118 eligible patients, 95 were randomised and 93 (31 in each group) completed the follow-ups. Three groups were not different regarding baseline BCVA (p=0.66), colour vision (p=0.25) and RAPD (p=0.79). All three groups showed a significant improvement of BCVA and RAPD with no significant differences among the groups. Colour vision showed a significant improvement only in the group with 3600 IU/kg EPO (p=0.005), even though final colour vision was not significantly different between the groups (p=0.49). Initial vision of no light perception (OR=7.79 (95% CI: 2.98 to 20.36), p<0.001), older age (OR=4.76 (95% CI: 1.92 to 11.76), p<0.001), longer trauma-treatment interval (OR=2.72, 95% CI: 1.16 to 6.33, p=0.02) and posterior orbital fractures (OR=2.63 (95% CI: 1.13 to 6.13), p=0.02) led to a significantly worse visual recovery. Conclusion Increasing dose of EPO in patients with TON did not result in a better BCVA, colour vision and RAPD improvement. Trial registration number [NCT03308448][1]. Data are available on reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03308448&atom=%2Fbjophthalmol%2Fearly%2F2024%2F10%2F25%2Fbjo-2024-325828.atom

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创伤性视神经病变治疗试验 2（TONTT-2）：评估不同剂量促红细胞生成素的疗效--一项多中心、随机、双盲临床试验

目的比较三种不同体重调整剂量的静脉注射促红细胞生成素（EPO）对间接创伤性视神经病变（TON）患者的疗效和安全性。方法该研究是一项多中心、随机、平行组、双盲、剂量调查试验，对象是年龄≥7 岁、确诊间接性视神经病变时间≤3 周的患者。试验的治疗期为 3 天，随访期为 3 个月。患者被随机分配（1:1:1）接受900 IU/kg（300 IU/kg/天）、1800 IU/kg（600 IU/kg/天）或3600 IU/kg（发病时600 IU/kg/天，1个月后）剂量的EPO。对最佳矫正视力（BCVA）、色觉和相对传入瞳孔缺损（RAPD）的变化进行了评估。结果在 118 名符合条件的患者中，95 人被随机选中，93 人（每组 31 人）完成了随访。三组患者的基线视力（BCVA）（P=0.66）、色觉（P=0.25）和相对传入性瞳孔缺损（RAPD）（P=0.79）均无差异。所有三组的 BCVA 和 RAPD 均有明显改善，组间无明显差异。只有 EPO 3600 IU/kg 组的色觉有明显改善（p=0.005），尽管最终色觉在各组间无明显差异（p=0.49）。初始视力无光感（OR=7.79（95% CI：2.98 至 20.36），p<0.001）、年龄较大（OR=4.76（95% CI：1.92 至 11.76），p<0.001）、创伤治疗间隔时间较长（OR=2.72，95% CI：1.16 至 6.33，p=0.02）和眼眶后部骨折（OR=2.63（95% CI：1.13 至 6.13），p=0.02）导致视力恢复明显较差。结论对TON患者增加EPO剂量并不能改善BCVA、色觉和RAPD。试验注册号[NCT03308448][1]。如有合理要求，可提供相关数据。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03308448&atom=%2Fbjophthalmol%2Fearly%2F2024%2F10%2F25%2Fbjo-2024-325828.atom

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来源期刊

British Journal of Ophthalmology 医学-眼科学

CiteScore

10.30

自引率

2.40%

发文量

213

审稿时长

3-6 weeks

期刊介绍： The British Journal of Ophthalmology (BJO) is an international peer-reviewed journal for ophthalmologists and visual science specialists. BJO publishes clinical investigations, clinical observations, and clinically relevant laboratory investigations related to ophthalmology. It also provides major reviews and also publishes manuscripts covering regional issues in a global context.