目的:研究玻璃体内注射英夫利昔单抗治疗增生性玻璃体视网膜病变(PVR)伴孔源性视网膜脱离(RRD)的安全性和有效性。
方法:随机对照2期临床试验。
方法:原发性RRD和C级PVR患者,根据更新的视网膜社会分类。
方法:66例患者以1:1的比例随机分配,接受PPV和硅油(SO)注射,有或没有玻璃体内注射1mg/0.05mL英夫利昔单抗,然后在PPV结束时进行SO注射。在PPV结束之前,外科医生被掩盖治疗分配。
方法:主要结局指标是解剖成功(定义为SO去除后6个月无填塞的视网膜完全恢复)。次要结果指标是最终最佳矫正视力(BCVA),单次手术成功率(SOSR),复发性脱离率,黄斑中心厚度(CMT)通过黄斑光学相干断层扫描(OCT),多焦视网膜电图黄斑功能和OCT血管造影黄斑血管密度(VD)。
结果:60例患者的60只眼,每组30只眼,完成研究。在基线,年龄没有差异,性别,外伤史,镜头状态,RRD的持续时间,BCVA,眼内压(IOP),眼内炎症(IOI),以时钟为单位的分离程度,中断数/大小,存在玻璃体出血,轴向长度,或两组之间PVR的等级/程度。对于结果措施,英夫利昔单抗组的30只眼实现了解剖成功,而对照组的29只眼实现了解剖成功。英夫利昔单抗组(26)的SOSR高于对照组(23),但这没有统计学意义(p=0.317).英夫利昔单抗组的最终BCVA更好(平均logMAR(SD)=0.96(0.4),斯内伦当量≈20/180)与对照组(1.14(0.4),斯内伦当量≈20/280)(p=0.044)。关于IOP没有差异,IOI,去除SO的时间,黄斑功能,CMT,或VD。
结论:PPV伴SO填塞伴或不伴玻璃体内注射英夫利昔单抗可有效治疗PVR相关RRD。英夫利昔单抗可能与最终视觉结果的适度改善有关,但与解剖学结果无关。
OBJECTIVE: To study the safety and efficacy of intravitreal infliximab administered at the conclusion of pars plana vitrectomy (PPV) in the treatment of proliferative vitreoretinopathy (PVR) associated with rhegmatogenous retinal detachment (RRD).
METHODS: Randomized controlled phase II clinical trial.
METHODS: Patients with primary RRD and grade C PVR, according to the updated Retina Society Classification.
METHODS: Sixty-six patients were randomized in a 1:1 ratio to undergo PPV and silicone oil (SO) injection with or without intravitreal injection of 1 mg/0.05 mL of infliximab in the air-filled globe before SO injection at PPV conclusion. Surgeons were masked to treatment allocation until PPV conclusion.
METHODS: The primary outcome measure was anatomic success (defined as complete retinal reattachment without a tamponade at 6 months post SO removal). Secondary outcome measures were final best-corrected visual acuity (BCVA), single-operation success rate (SOSR), rate of recurrent detachment, central macular thickness (CMT) by macular OCT, macular function by multifocal electroretinogram, and macular vascular density (VD) by OCT angiography.
RESULTS: Sixty eyes of 60 patients, 30 eyes in each group, completed the study. At baseline, there were no differences regarding age, gender, history of trauma, lens status, duration of RRD, BCVA, intraocular pressure (IOP), intraocular inflammation (IOI), detachment extent in clock hours, number/size of breaks, presence of vitreous hemorrhage, axial length, or grade/extent of PVR between both groups. For the outcome measures, 30 eyes in the infliximab group achieved anatomic success vs. 29 eyes in the control group. The SOSR was higher in the infliximab group (26) vs. the control (23), but this was not statistically significant (P = 0.317). Final logarithm of the minimum angle of resolution BCVA was better in the infliximab group (mean, 0.96; standard deviation [SD], 0.4; Snellen equivalent ≈ 20/180) vs. the control (mean, 1.14; SD, 0.4); Snellen equivalent ≈ 20/280; P = 0.044). There were no differences regarding IOP, IOI, time of SO removal, macular function, CMT, or VD.
CONCLUSIONS: Pars plana vitrectomy with SO tamponade with or without intravitreal infliximab is effective in treating PVR-associated RRD. Infliximab may be associated with modest improvement in final visual outcomes but not anatomic outcomes.
BACKGROUND: The authors have no proprietary or commercial interest in any materials discussed in this article.