Karimi Saeed, Nouri Mehdi, Mansouri Amir Reza, Hassanzadeh Golnar, Nouri Hosein, Rikani Saber Mohsen, Abtahi Seyed-Hossein
Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Ophthalmology, Torfeh Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Int J Retina Vitreous. 2025 Apr 7;11(1):40. doi: 10.1186/s40942-025-00663-8.
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents are the standard of care in DME, a sight-threatening complication of diabetic retinopathy. However, many patients show suboptimal response to anti-VEGF agents alone. This study aimed to investigate the effect of adding interferon alpha 2b eye drops to intravitreal bevacizumab (IVB) in treating patients with DME.
In this double-blind, placebo-controlled, parallel clinical trial, eligible eyes of DME patients were randomized into two treatment arms: (1) three monthly doses of intravitreal bevacizumab (IVB) (2) three monthly doses of IVB plus interferon alpha 2b eye drops (IVB + IFN). Outcome measures were changes in central macular thickness (CMT) and best corrected visual acuity (BCVA) over four months. Intraocular pressure (IOP) and possible adverse events were also documented.
A total of 87 eyes of 87 patients with DME were included (mean age: 64.1, female-to-male ratio ~ 1:1). Anatomical and visual improvements were significant in both groups (p-value < 0.001). CMT reduction and BCVA improvement were greater in the IVB + IFN compared to the IVB group (-117 μm vs. -54 μm, 0.2 vs. 0.1 LogMAR, p-values = 0.004 and < 0.001, respectively). Final IOP was lower in the IVB + IFN group (p value = 0.02), but within groups changes were not significant in either arm (p-value > 0.05). No serious side effects associated with IFN alpha 2b were observed.
Adjunction of topical IFN alpha 2b to standard IVB therapy may result in superior functional and structural improvements in eyes with DME in short-term follow-up.
Iranian Registry of Clinical Trials (irct.behdasht.gov.ir), IRCT20230103057035N1, March 18th, 2023.
玻璃体内抗血管内皮生长因子（抗VEGF）药物是糖尿病性黄斑水肿（DME）的标准治疗方法，DME是糖尿病视网膜病变的一种威胁视力的并发症。然而，许多患者单独对抗VEGF药物的反应欠佳。本研究旨在探讨在玻璃体内注射贝伐单抗（IVB）治疗DME患者时加用干扰素α-2b滴眼液的效果。
在这项双盲、安慰剂对照、平行临床试验中，将符合条件的DME患者的眼睛随机分为两个治疗组：（1）每三个月注射一次玻璃体内贝伐单抗（IVB）；（2）每三个月注射一次IVB加干扰素α-2b滴眼液（IVB + IFN）。观察指标为四个月内中心黄斑厚度（CMT）和最佳矫正视力（BCVA）的变化。还记录了眼压（IOP）和可能的不良事件。
共纳入87例DME患者的87只眼（平均年龄：64.1岁，男女比例约为1:1）。两组的解剖学和视力改善均显著（p值<0.001）。与IVB组相比，IVB + IFN组的CMT降低和BCVA改善更大（分别为-117μm对-54μm，0.2对0.1 LogMAR，p值分别为0.004和<0.001）。IVB + IFN组的最终眼压较低（p值 = 0.02），但两组内的变化在任何一组中均不显著（p值>0.05）。未观察到与干扰素α-2b相关的严重副作用。
在标准IVB治疗中加用局部干扰素α-2b可能会在短期随访中使DME患者的眼睛在功能和结构上得到更好的改善。
伊朗临床试验注册中心（irct.behdasht.gov.ir），IRCT20230103057035N1，2023年3月18日。
