Department of Ophthalmology, Key laboratory of Ocular Fundus Diseases, Peking Union Medical College Hospital, Beijing, China.
Medical Research Center, Peking Union Medical College Hospital, Beijing, China.
BMJ Open. 2022 Dec 7;12(12):e062211. doi: 10.1136/bmjopen-2022-062211.
Paediatric patients with chronic anterior uveitis are more prone to suffer from the chronic course of intraocular inflammation and adverse effects of long-term immunomodulatory therapy, either topical glucocorticosteroids or systemic immunomodulatory agents. The performance of adalimumab has been shown to be fairly favourable in treating refractory non-infectious uveitis, but the detailed indication is still under investigation. This study aims to assess the efficacy and safety of adalimumab for inflammatory flare prevention in non-infectious paediatric anterior uveitis with peripheral retinal vascular leakage, compared with methotrexate.
Children weighed ≥30 kg and aged between 4 and 16 years old with active non-infectious anterior uveitis with peripheral retinal vascular leakage on ultra-wildfield fluorescein fundus angiography will be included. They will be treated with a predesigned inflammatory control regimen to reach inflammatory quiescence in 1 month. After that they will be treated with either methotrexate 10 mg once a week or adalimumab once every 2 weeks and regularly followed up for 6 months. The primary endpoint is uveitis flare defined as defined as anterior chamber cell count grading increased from 0 to 1 within the observation period.
The study was approved by the Institutional Review Board of Peking Union Medical College Hospital, Beijing, China (Approved protocol V3, dated 27 July 2021. Approval number 25-ZS-3062) and has been registered on ClinicalTrials.gov. Written informed consent will be collected from every patient and their guardians prior to study participation. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.
NCT05015335.
患有慢性前葡萄膜炎的儿科患者更容易遭受眼内炎症的慢性过程和长期免疫调节治疗（局部糖皮质激素或全身免疫调节剂）的不良反应。阿达木单抗在治疗难治性非感染性葡萄膜炎方面表现出相当有利的效果，但详细的适应证仍在研究中。本研究旨在评估阿达木单抗与甲氨蝶呤相比，在预防非感染性儿童前葡萄膜炎伴周边视网膜血管渗漏的炎症发作方面的疗效和安全性。
将纳入体重≥30kg 且年龄在 4 至 16 岁之间、超野荧光素眼底血管造影显示有活动性非感染性前葡萄膜炎伴周边视网膜血管渗漏的儿童。他们将接受预设的炎症控制方案治疗，以在 1 个月内达到炎症静止。之后，他们将接受甲氨蝶呤每周 10mg 或阿达木单抗每 2 周 1 次治疗，并定期随访 6 个月。主要终点是葡萄膜炎发作，定义为观察期内前房细胞计数从 0 级增加到 1 级。
该研究已获得中国北京协和医学院北京协和医院机构审查委员会的批准（批准方案 V3，日期为 2021 年 7 月 27 日，批准号 25-ZS-3062），并已在 ClinicalTrials.gov 上注册。在研究参与之前，将从每位患者及其监护人处收集书面知情同意书。本试验的结果将在当地和国际会议上公布，并提交给同行评议的期刊发表。
NCT05015335。
