Lashay Alireza, Faghihi Hooshang, Mirshahi Ahmad, Khojasteh Hassan, Khodabande Alireza, Riazi-Esfahani Hamid, Amoli Fahimeh Asadi, Pour Elias Khalili, Delrish Elham
Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
J Ophthalmic Vis Res. 2020 Aug 6;15(3):341-350. doi: 10.18502/jovr.v15i3.7453. eCollection 2020 Jul-Sep.
To evaluate the safety of intravitreal injection of Stivant, a biosimilar to bevacizumab, in rabbits using electrophysiological and histological analysis.
Both eyes of 41 New Zealand albino rabbits were injected with 0.1 mL (2.5 mg) of Stivant. The rabbits were scheduled to be sacrificed 1, 2, 7, 14, and 28 days after injection for histopathological evaluations. Clinical examinations and electroretinography (ERG) were performed at baseline and just before sacrificing the rabbits. Fourteen separate rabbits received a reference drug (Avastin) and were considered as the control group. Furthermore, three other rabbits received the same volume of saline (saline control group). Rabbits of both control groups were sacrificed four weeks after injection. ERG was performed 1, 2, 7, 14, and 28 days after injections.
No significant difference was observed in a- and b-wave amplitudes and latency after intravitreal Stivant injection between baseline and different time points. Moreover, there was no statistically significant difference in wave amplitudes and latency between the Stivant and control groups. The histology of rabbit eyes of the Stivant and control groups after intravitreal injections was not distinguishable.
The biosimilar Stivant, up to a dose of 2.5 mg, did not appear to be toxic to the retina in albino rabbits. These results suggest that this drug could be a safe and inexpensive alternative to intravitreal bevacizumab. The efficacy of these injections was not investigated in this study and needs to be evaluated in future studies.
通过电生理和组织学分析，评估玻璃体内注射与贝伐单抗生物类似药Stivant对家兔的安全性。
给41只新西兰白兔的双眼注射0.1 mL（2.5 mg）的Stivant。计划在注射后1、2、7、14和28天处死家兔以进行组织病理学评估。在基线时以及处死家兔前进行临床检查和视网膜电图（ERG）检查。另外14只家兔接受对照药物（阿瓦斯汀），被视为对照组。此外，另有3只家兔接受相同体积的生理盐水（生理盐水对照组）。两个对照组的家兔在注射后四周处死。在注射后1、2、7、14和28天进行ERG检查。
玻璃体内注射Stivant后，在基线和不同时间点之间，a波和b波的振幅及潜伏期未观察到显著差异。此外，Stivant组和对照组之间在波幅和潜伏期方面没有统计学上的显著差异。玻璃体内注射后，Stivant组和对照组家兔眼睛的组织学表现无明显差异。
高达2.5 mg剂量的生物类似药Stivant对白化病家兔视网膜似乎没有毒性。这些结果表明，这种药物可能是玻璃体内注射贝伐单抗的一种安全且廉价的替代药物。本研究未调查这些注射的疗效，未来研究需要对其进行评估。
