Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Trials. 2022 Sep 2;23(1):736. doi: 10.1186/s13063-022-06593-2.
At present, intraocular injection of anti-VEGF (vascular endothelial growth factor) drugs has replaced traditional laser therapy as the first-line treatment for DME (diabetic macular edema). However, ranibizumab, a commonly used anti-VEGF drug, is expensive and requires multiple intraocular injections. It places a heavy economic burden on patients with DME. Micropulse laser is safer than conventional laser and can reduce edema. Combined treatment with anti-VEGF may reduce the number of intraocular injections. This study will compare the efficacy of micropulse laser combined with ranibizumab treatment to ranibizumab monotherapy in the treatment of DME, providing a new regimen for future DME treatment.
This study is a prospective randomized double-blind controlled clinical trial (RCT) in patients with DME. After 1-year follow-up, visual acuity and macular edema regression will be compared between micropulse laser combined with ranibizumab group and ranibizumab monotherapy group to determine whether the efficacy of micropulse laser combined with ranibizumab treatment was not lower than that of ranibizumab monotherapy in the treatment of DME. Visual acuity measured by the ETDRS chart is the primary outcome measure. The secondary outcome measures are CMT (central macular thickness) measured by OCT (optical coherence tomography) and the number of injections of two groups. Changes in visual acuity and CMT of the two groups will be compared at 12-month follow-up. Before patients are recruited, we provide them with informed consent, in which we explain to them the purpose and process of the study.
Micropulse laser combined with anti-VEGF drugs in the treatment of DME can reduce the number of intravitreal anti-VEGF injections, not only relieve the pain of the patients, but also ease the economic and psychological burden of patients, bringing great benefits. However, there is no treatment consensus for the parameters and specific methods of micropulse laser treatment for DME. There is a lack of clinical research data reference of micropulse laser combined with anti-VEGF therapy in clinical practice. This study intends to provide a new direction for clinical DME treatment and also provide a realistic consideration for the application of micropulse laser in DME treatment.
ClinicalTrials.gov NCT03690947. Registered on 1 October 2018.
目前，眼内注射抗血管内皮生长因子（VEGF）药物已取代传统激光疗法，成为糖尿病黄斑水肿（DME）的一线治疗方法。然而，作为一种常用的抗 VEGF 药物，雷珠单抗价格昂贵，需要多次眼内注射，给 DME 患者带来了沉重的经济负担。微脉冲激光比传统激光更安全，可以减轻水肿。抗 VEGF 联合治疗可能会减少眼内注射次数。本研究将比较微脉冲激光联合雷珠单抗治疗与雷珠单抗单药治疗 DME 的疗效，为今后 DME 的治疗提供新方案。
本研究是一项前瞻性随机双盲对照临床试验（RCT），纳入 DME 患者。随访 1 年后，比较微脉冲激光联合雷珠单抗组和雷珠单抗单药组的视力和黄斑水肿消退情况，以确定微脉冲激光联合雷珠单抗治疗的疗效是否不低于雷珠单抗单药治疗 DME。以 ETDRS 图表测量的视力为主要观察指标。次要观察指标为 OCT 测量的 CMT（中央黄斑厚度）和两组的注射次数。比较两组患者 12 个月随访时的视力和 CMT 变化。在招募患者之前，我们向他们提供知情同意书，向他们解释研究的目的和过程。
微脉冲激光联合抗 VEGF 药物治疗 DME 可以减少眼内抗 VEGF 注射次数，不仅减轻患者的痛苦，还能缓解患者的经济和心理负担，带来巨大的益处。然而，对于 DME 微脉冲激光治疗的参数和具体方法尚无治疗共识，也缺乏微脉冲激光联合抗 VEGF 治疗在临床实践中的临床研究数据参考。本研究旨在为临床 DME 治疗提供新的方向，也为微脉冲激光在 DME 治疗中的应用提供现实的考虑。
ClinicalTrials.gov NCT03690947. 注册于 2018 年 10 月 1 日。
