Efficacy and safety analysis of intravitreal bio-similar products of bevacizumab in patients with macular edema because of retinal diseases

贝伐单抗玻璃体内注射生物类似药治疗视网膜疾病引起的黄斑水肿患者的疗效和安全性分析

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Abstract

PURPOSE: The purpose of this study was to evaluate retrospectively the efficacy and safety profile of intravitreal injection of bevacizumab bio-similar product Zybev(Z) for macular edema because of retinal diseases. METHODS: A retrospective analysis was conducted on patients with macular edema because of retinal diseases, who had been administered intravitreal injections of bio-similar bevacizumab at a tertiary eye care center. Changes in the retinal thickness and visual acuity were evaluated to judge the efficacy, and adverse events were noted for the safety profile over a period of 6 weeks. RESULTS: A total of 104 patients were included in the study. The mean age of the patients was 53 ± 13.5 years. The mean pre-injection best corrected visual acuity (BCVA) was 1.32 ± 0.70 log minimum angle of resolution (logMAR) with a central subfield thickness (CST) of 429.26 ± 204.30 μm, and the post-injection BCVA at 6 weeks was 1.13 ± 0.71 logMAR with a CST of 302.26 ± 104.50 μm; this change was statistically significant (P < 0.05) for all groups. The mean average cube thickness (μm) decreased from 11.85 ± 1.96 pre-injection to 10.52 ± 1.75 post-injection, and the mean average cube volume (mm(3)) decreased from 329.30 ± 54.35 to 302.23 ± 49.56 (P < 0.05). During the follow-up period after injection, no patient had inflammation, endophthalmitis, an increase in intra-ocular pressure, or systemic side effects. CONCLUSION: This short-term retrospective analysis provides evidence regarding the efficacy and safety of intravitreal injection of bio-similar products of bevacizumab for the treatment of macular edema because of retinal diseases.

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