Comparison of efficacy and safety of intravitreal ranibizumab and conbercept before vitrectomy in Chinese proliferative diabetic retinopathy patients: a prospective randomized controlled trial.

Eye and vision (London, England) Pub Date : 2022-12-01 DOI:10.1186/s40662-022-00316-z

Siying Li, Lili Guo, Pingping Zhou, Jiyang Tang, Zongyi Wang, Linqi Zhang, Mingwei Zhao, Jinfeng Qu

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引用次数: 1

Abstract

Background: To compare the efficacy and safety of preoperative intravitreal injections of ranibizumab and conbercept in Chinese proliferative diabetic retinopathy (PDR) patients.

Methods: This prospective randomized controlled trial enrolled 90 eyes of 80 patients with PDR. Forty-four eyes of 40 patients that received intravitreal ranibizumab (IVR) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVR group. Forty-six eyes of 40 patients that received intravitreal conbercept (IVC) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVC group. Intraoperative and postoperative indices were assessed for further comparison between the two groups.

Results: There were no statistically significant differences in all surgery indices, including intraoperative indices (surgery time, P = 0.225; intraoperative bleeding, P = 0.808; endodiathermy use, P = 0.693; incidence of iatrogenic retinal breaks, P = 0.740; relaxing retinotomy, P = 0.682; retinal reattachment, P = 0.682 and silicone oil tamponade, P = 0.814) and postoperative indices (postoperative vitreous hemorrhage (VH), P = 0.808; neovascular glaucoma (NVG), P = 0.964; recurrent retinal detachment, P = 0.531; postoperative fibrovascular proliferation progression, P = 0.682 and reoperation, P = 0.955) between the two groups. There were no statistically significant differences in best-corrected visual acuity (BCVA) at each follow-up visit (P = 0.939, 0.669, 0.741 and 0.717, respectively) or in central retinal thickness (CRT) (P = 0.976, 0.699, 0.551 and 0.686, respectively). As for safety profile, both groups had no ocular or system adverse events during the observation period.

Conclusions: IVR and IVC as a pretreatment of vitrectomy had similar efficacy and safety profile for Chinese PDR patients.

Trial registration: Registered at ClinicalTrials.gov ( NCT05414149 ).

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中国增殖性糖尿病视网膜病变患者玻璃体切除术前玻璃体内注射雷尼单抗和康伯莱的疗效和安全性比较:一项前瞻性随机对照试验。

背景:比较雷尼单抗和康伯利在中国增殖性糖尿病视网膜病变(PDR)患者术前玻璃体内注射的疗效和安全性。方法:本前瞻性随机对照试验纳入80例PDR患者90只眼。在玻璃体手术前接受雷尼珠单抗(IVR)注射(0.5 mg/0.05 mL)的40例患者44只眼被分配到IVR组。选取40例玻璃体手术前接受玻璃体内注射(0.5 mg/0.05 mL)的患者46只眼作为玻璃体内注射组。评估两组患者术中及术后各项指标，进行进一步比较。结果:两组手术各项指标，包括术中指标(手术时间，P = 0.225;术中出血，P = 0.808;内透使用，P = 0.693;医源性视网膜断裂发生率，P = 0.740;松弛性视网膜切开术，P = 0.682;视网膜再植，P = 0.682，硅油填塞，P = 0.814)和术后指标(术后玻璃体出血，P = 0.808;新生血管性青光眼(NVG)， P = 0.964;复发性视网膜脱离，P = 0.531;两组术后纤维血管增殖进展(P = 0.682)和再手术(P = 0.955)。两组患者每次随访最佳矫正视力(BCVA) (P分别为0.939、0.669、0.741、0.717)和视网膜中央厚度(CRT) (P分别为0.976、0.699、0.551、0.686)差异均无统计学意义。在安全性方面，两组在观察期间均未发生眼部或系统不良事件。结论:IVC和IVC作为玻璃体切除术的前处理对中国PDR患者具有相似的疗效和安全性。试验注册:在ClinicalTrials.gov注册(NCT05414149)。

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Eye and vision (London, England)

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