Li Xiangjun, Li Chunyan, Huang Hai, Bai Dan, Wang Jingyi, Chen Anqi, Gong Yu, Leng Ying
Department of Ophthalmology, Affiliated Hospital of Beihua University, Jilin, Jilin Province, China.
Department of Endocrinology, Affiliated Hospital of Beihua University, Jilin, Jilin Province, China.
Neural Regen Res. 2024 Apr;19(4):923-928. doi: 10.4103/1673-5374.382104.
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).
视网膜神经节细胞的完整性与糖尿病性黄斑变性密切相关，糖尿病性黄斑变性会导致视网膜神经节细胞受损和死亡，从而影响视力。糖尿病性黄斑水肿的主要临床治疗方法是抗血管内皮生长因子药物和激光光凝治疗。然而，尽管单独使用这两种疗法中的任何一种都可以使黄斑厚度恢复正常，但许多患者的视力并未改善。这可能是由于视网膜神经节细胞损伤未完全恢复所致。因此，设计了一项前瞻性、非随机、对照临床试验，以研究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完整性的影响及其与视力恢复的关系。在该试验中，150例糖尿病性黄斑水肿患者将根据治疗方法平均分为三组，然后分别接受抗血管内皮生长因子药物治疗、激光光凝治疗及其联合治疗。所有患者将接受12个月的随访。主要观察指标是治疗后12个月时视网膜神经节细胞-内丛状层厚度。次要观察指标包括治疗前及治疗后1、3、6和9个月时视网膜神经节细胞-内丛状层厚度、视网膜神经纤维层厚度、最佳矫正视力、黄斑区厚度以及治疗前及治疗后1、3、6、9和12个月时脉络膜厚度。安全性指标是治疗后1、3、6、9和12个月时不良事件的发生率。该研究方案希望在12个月的随访期内验证联合治疗相对于其他两种单一疗法在糖尿病性黄斑患者中的更好疗效和安全性。该试验旨在重点阐明与视网膜神经节细胞完整性相关的影像学指标与最佳矫正视力之间的时效关系。该试验方案于2023年4月25日获得北华大学附属医院医学伦理委员会批准，批准号为(2023)(26)，并在中国临床试验注册中心注册（注册号：ChiCTR2300072478，2023年6月14日，方案版本：2.0）。
