METHODS: This single-center, prospective, nonrandomized, case-control trial involved patients with refractory ME that responded poorly to three or more initial anti-VEGF injections. The patients were examined and divided into two groups according to their chosen treatment: the intravitreal ranibizumab (IVR) group and the SMLP group. Both groups were followed up monthly for 12 months. Therapeutic efficacy and safety were assessed throughout the follow-up period.
RESULTS: The IVR group comprised 49 eyes, and the SMLP group comprised 45 eyes. The improvements in the optical coherence tomography findings and visual acuity were comparable between the two groups at the final follow-up. The total number of injections was significantly lower in the SMLP than IVR group. No serious adverse events occurred during the study period.
CONCLUSIONS: SMLP therapy is better for patients with central macular thickness (CMT) of ≤400 μm. For patients with CMT of >400 μm, we advise continuation of anti-VEGF agents to reduce ME followed by application of SMLP therapy when CMT has decreased to ≤400 μm.
方法:这种单中心,prospective,非随机化,病例对照试验纳入了难治性ME患者,这些患者对3次或3次以上初始抗VEGF注射反应较差.对患者进行检查,并根据其选择的治疗方法分为两组:玻璃体内雷珠单抗(IVR)组和SMLP组。两组均每月随访12个月。在整个随访期间评估治疗效果和安全性。
结果:IVR组包括49只眼,SMLP组有45只眼。在最后的随访中,两组的光学相干断层扫描结果和视力的改善具有可比性。SMLP组的注射总数明显低于IVR组。研究期间未发生严重不良事件。
结论:SMLP治疗对于黄斑中心厚度(CMT)≤400μm的患者更好。对于CMT>400μm的患者,我们建议在CMT降至≤400μm时,继续应用抗VEGF药物以减少ME,然后应用SMLP治疗.