目的:本研究旨在评估抗VEGF联合地塞米松植入治疗视网膜静脉阻塞伴黄斑水肿的疗效和安全性。
方法:在此前瞻性中,病例控制,队列临床试验(注册编号:ChiCTR2400080048),研究对象为2020年8月至2023年4月三门峡市中心医院非缺血性视网膜静脉阻塞患者.将患者随机分为两组。所有患者在前3个月内接受雷珠单抗玻璃体内注射。对于雷珠单抗组来说,在黄斑水肿复发的情况下,根据需要注射抗VEGF;对于联合组,患者在首次注射雷珠单抗后第15天接受玻璃体内注射地塞米松.主要结果测量是最佳矫正视力(BCVA)的改善和中央黄斑厚度(CMT)的减少。次要结果是黄斑水肿复发,玻璃体内注射次数,和注射间隔。还记录了安全概况。
结果:共纳入124例患者,其中73例患者完成了所有随访。雷珠单抗单一疗法和联合疗法在所有时间点均显着改善了BCVA。与基线相比。联合组在3个月内获得了更多的BCVA改善,6个月,还有12个月,与单独使用雷珠单抗组相比。与基线相比,在所有随访中,两组的CMT均显著减少.然而,组合组在注射后1周显示更多的CMT减少,与雷珠单抗组相比。联合组的注射间隔明显更长,较低的注射时间,黄斑水肿复发。眼部高血压是最常见的不良事件。最后,无手术干预的1-3种青光眼药物均能很好地控制眼压.
结论:联合治疗可显著改善BCVA并降低CMT,具有良好的安全性。
OBJECTIVE: This study aimed to assess the efficacy and safety of anti-VEGF combined with dexamethasone implant for the retinal vein occlusion patients with macular edema.
METHODS: In this prospective,
case-controlled, cohort clinical trial (Register ID: ChiCTR2400080048), patients with non-ischemic retinal vein occlusion were enrolled from the Sanmenxia Central Hospital from August 2020 to April 2023. The patients were randomized into two groups. All the patients received ranibizumab intravitreal injection in the first 3 consecutive months. For the ranibizumab group, anti-VEGF injections were as needed thereafter in
case of recurrence of macular edema; For the combination group, the patients received an intravitreal dexamethasone implant injection at 15 days after the first ranibizumab injection. The primary outcome measurements were improvement in best corrected visual acuity (BCVA) and reduction in central macular thickness (CMT). The secondary outcomes were recurrence of macular edema, number of intravitreal injections, and injection interval. Safety profiles were also recorded.
RESULTS: A total of 124 patients were included, of which 73 patients completed all follow-ups. Both the ranibizumab monotherapy and the combination therapy significantly improved BCVA at all time points, compared to the baseline. The combined group achieved more BCVA improvement in 3 months, 6 months, and 12 months, compared to the ranibizumab alone group. Compared to the baseline, both groups achieved significant reductions in CMT at all follow-ups. However, the combination group showed more CMT reduction at 1 week post injection, compared to the ranibizumab group. The combination group had a significantly longer injection interval, lower injection time, and recurrence of macular edema. Ocular hypertension was the most common adverse events. Lastly, intraocular pressure was all well controlled by 1-3 glaucoma medications without surgical intervention.
CONCLUSIONS: The combination therapy could significantly improve the BCVA and reduce the CMT with a good safety profile.