Incidence of inflammatory reactions after intravitreal injection of a biosimilar of ranibizumab for the treatment of various retinal vascular conditions

V. Wani, A. Agarwal, A. Tenagi, Bhagyajyothi B. Khanagavi, S. Bubanale, Nagbhushan S Chougule, Chethana Warad
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Abstract

BACKGROUND: Razumab is a biosimilar of ranibizumab and its intravitreal injection in various retinal diseases has been reported with good results. However, the incidence of inflammation in the anterior chamber and vitreous after the intravitreal injection of Razumab has not been studied so far. AIMS OF THE STUDY: The aim of this study was to study the incidence of inflammatory reaction in the anterior chamber and vitreous after intravitreal Razumab. MATERIALS AND METHODS: It was a single-center, nonrandomized observational study of eyes that received intravitreal Razumab injection for various retinal indications. The eyes were examined for anterior chamber and vitreous reaction at regular intervals. Preinjection and postinjection visual acuity and intraocular pressure (IOP) were noted. STATISTICAL ANALYSIS: The proportion of eyes developing anterior chamber and vitreous reaction were calculated with confidence intervals. The pre- and postinjection visual acuity and IOP were compared by Student's t-test for significant changes. RESULTS: Eighty-two injections were performed in 40 eyes of 33 patients. Four eyes (4.8%) showed anterior chamber reaction among which one eye had vitreous reaction also. All four eyes had no adverse effect on visual acuity and recovered completely. Mean preinjection logMAR visual acuity of 0.69 ± 0.41 improved to 0.58 ± 0.38 postinjection (P < 0.0001). The mean preinjection IOP changed from 16.2 ± 3.9 mmHg to 14.7 ± 3.4 mmHg postinjection (P = 0.009). CONCLUSIONS: The incidence of inflammatory reaction was found to be higher with Razumab compared to the incidence reported in the literature for ranibizumab. However, visual acuity was not affected by this inflammatory reaction.
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用于治疗各种视网膜血管疾病的雷尼单抗生物仿制药玻璃体内注射后炎症反应的发生率
背景:Razumab是雷尼单抗的生物类似药,其玻璃体内注射治疗多种视网膜疾病已有报道,效果良好。然而,玻璃体内注射Razumab后前房和玻璃体炎症的发生率目前尚无研究。研究目的:本研究的目的是研究玻璃体内注射Razumab后前房和玻璃体炎症反应的发生率。材料和方法:这是一项单中心、非随机观察性研究,接受玻璃体内注射Razumab治疗各种视网膜适应症。定期检查前房和玻璃体反应。观察注射前和注射后的视力和眼压。统计学分析:采用置信区间计算眼前房及玻璃体反应发生率。注射前后视敏度和IOP比较,采用Student’st检验,差异有统计学意义。结果:33例患者40只眼共进行82次注射。4眼(4.8%)有前房反应,其中1眼也有玻璃体反应。四眼视力均无不良影响,完全恢复。平均注射前的logMAR视力由0.69±0.41提高到0.58±0.38 (P < 0.0001)。平均眼压由注射前16.2±3.9 mmHg降至注射后14.7±3.4 mmHg (P = 0.009)。结论:与文献报道的雷尼单抗相比,Razumab的炎症反应发生率更高。然而,这种炎症反应不影响视力。
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审稿时长
32 weeks
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