中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2024, Vol. 19 ›› Issue (4): 923-928.doi: 10.4103/1673-5374.382104

• 原著:视神经损伤修复保护与再生 • 上一篇    

抗血管内皮生长因子药物联合激光光凝治疗维持糖尿病性黄斑水肿患者视网膜神经节细胞的完整性：前瞻性、非随机对照临床试验方案

  

  • 出版日期:2024-04-15 发布日期:2023-09-15

Anti-vascular endothelial growth factor drugs combined with laser photocoagulation maintain retinal ganglion cell integrity in patients with diabetic macular edema: study protocol for a prospective, non-randomized, controlled clinical trial

Xiangjun Li1, Chunyan Li2, Hai Huang2, Dan Bai1, Jingyi Wang1, Anqi Chen2, Yu Gong2, Ying Leng1, *   

  1. 1Department of Ophthalmology, Affiliated Hospital of Beihua University, Jilin, Jilin Province, China; 2Department of Endocrinology, Affiliated Hospital of Beihua University, Jilin, Jilin Province, China
  • Online:2024-04-15 Published:2023-09-15
  • Contact: Ying Leng, MD, lengyingeye@126.com.
  • Supported by:
    This work was supported by Science and Technology Research Project of Jilin Provincial Department of Education, No. JJKH20220072KJ (to XL) and Science and Technology Development Program of Jilin Province, No. 20200201495JC (to YL). 

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摘要：

视网膜神经节细胞的完整性与糖尿病性黄斑变性存在着密切的关系，糖尿病性黄斑变性会导致视网膜神经节细胞的损伤和死亡，进而影响黄斑区域的视力表现。目前临床治疗糖尿病性黄斑水肿的主要方法为抗血管内皮生长因子药物和联合激光光凝治疗。然而，目前许多患者采用上述的单独疗法治疗后虽然黄斑部厚度虽然恢复正常，但视力并未改善，其原因可能与视网膜神经节细胞损伤尚未完全恢复有关。为此，试验以此设计了一项前瞻性、非随机对照临床试验方案，观察了抗血管内皮生长因子药物联合激光光凝治疗对糖尿病性黄斑水肿患者视网膜神经节细胞的完整性的影响，以及其与视力恢复的关系。该试验将糖尿病性黄斑水肿患者150例按治疗方式分为3组，每组50例，分别采用抗血管内皮生长因子药物治疗、激光光凝治疗、抗血管内皮生长因子药物与视网膜激光光凝术治疗联合治疗进行干预，术后均随访12个月。主要结局指标为治疗后12个月视网膜神经节细胞内丛状层厚度；次要结局指标为治疗前、治疗后1、3、6、9个月视网膜神经节细胞内丛状层厚度，治疗前、治疗后1、3、6、9、12个月视网膜神经纤维层厚度、最佳矫正视力、黄斑区厚度、脉络膜厚度；安全性指标为治疗后1、3、6、9、12个月的不良反应发生率。该试验方案预计在治疗后12个月的随访期内，证实联合治疗的糖尿病性黄斑患者的疗效及安全性优于其他单独干预的2组，并重点明确视网膜神经节细胞的完整性相关影像学指标与最佳矫正视力的时效关系。该试验方案已经过北华大学附属医院医学伦理委员会批准，伦理批准号：(2023)年第(26)号，批准时间：2023-04-25。该研究方案已经在中国临床试验注册中心注册(注册号：ChiCTR2300072478)，注册时间：2023-06-14，方案版本号：2.0。

https://orcid.org/0000-0003-3504-0101 (Ying Leng)

关键词: 糖尿病性黄斑水肿, 视网膜神经节细胞, 血管内皮生长因子, 激光光凝疗法, 视网膜神经纤维层厚度, 视网膜神经节细胞和内丛状层厚度, 视力, 黄斑区厚度, 脉络膜厚度

Abstract: The integrity of retinal ganglion cells is tightly associated with diabetic macular degeneration that leads to damage and death of retinal ganglion cells, affecting vision. The major clinical treatments for diabetic macular edema are anti-vascular endothelial growth factor drugs and laser photocoagulation. However, although the macular thickness can be normalized with each of these two therapies used alone, the vision does not improve in many patients. This might result from the incomplete recovery of retinal ganglion cell injury. Therefore, a prospective, non-randomized, controlled clinical trial was designed to investigate the effect of anti-vascular endothelial growth factor drugs combined with laser photocoagulation on the integrity of retinal ganglion cells in patients with diabetic macular edema and its relationship with vision recovery. In this trial, 150 patients with diabetic macular edema will be equally divided into three groups according to therapeutic methods, followed by treatment with anti-vascular endothelial growth factor drugs, laser photocoagulation therapy, and their combination. All patients will be followed up for 12 months. The primary outcome measure is retinal ganglion cell-inner plexiform layer thickness at 12 months after treatment. The secondary outcome measures include retinal ganglion cell-inner plexiform layer thickness before and 1, 3, 6, and 9 months after treatment, retinal nerve fiber layer thickness, best-corrected visual acuity, macular area thickness, and choroidal thickness before and 1, 3, 6, 9, and 12 months after treatment. Safety measure is the incidence of adverse events at 1, 3, 6, 9, and 12 months after treatment. The study protocol hopes to validate the better efficacy and safety of the combined treatment in patients with diabetic macula compared with the other two monotherapies alone during the 12-month follow-up period. The trial is designed to focus on clarifying the time-effect relationship between imaging measures related to the integrity of retinal ganglion cells and best-corrected visual acuity. The trial protocol was approved by the Medical Ethics Committee of the Affiliated Hospital of Beihua University with approval No. (2023)(26) on April 25, 2023, and was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR2300072478, June 14, 2023, protocol version: 2.0).

Key words: choroidal thickness, diabetic macular edema, laser photocoagulation, retinal ganglion cell-inner plexiform layer thickness, retinal ganglion cells, retinal nerve fiber layer thickness, thickness of the macular area, vascular endothelial growth factor, visual acuity