Abstract
Purpose To report the results of intravitreal injection of a bevacizumab biosimilar called StivantⓇMethodsThis prospective interventional case series was conducted on eyes with neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME). StivantⓇ was injected in three consecutive months and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline and monthly up to one month after the third injection.Results Three hundred and eighty-five eyes with DME (234 eyes, 61%), nAMD (87 eyes, 22%), and macular edema secondary to RVO (64 eyes, 17%) were enrolled. The mean standard deviation age of the patients was 61.7 7.20 years. The mean BCVA and CMT changed from 0.63 0.3 to 0.51 0.3 LogMAR (P = 0.12 ) and from 420.4 47.3μm at baseline to 316.7 50.6 μm (P 0.001) in the DME group; from 0.79 0.3 to 0.68 0.3 LogMAR (P = 0.19) and from 376.1 31.7 μm to 303 31.3 μm (P = 0.019) in the nAMD group; and from 0.81 0.4 to 0.63 0.4 LogMAR (P = 0.05) and from 424.21 18 μm to 303.4 18.8 μm (P 0.001) in the RVO group, respectively.Conclusion Our limited experience showed that the intravitreal injection of StivantⓇ was well tolerated. Although the results of this case series showed relative improvement in CMT one month after the last injection of StivantⓇ, BCVA improvement was statistically significant only in the RVO group. This would be essential to design a randomized clinical trial to evaluate the non-inferiority of StivantⓇ in comparison to bevacizumab.
Highlights
Introduction of anti-VEGFs has revolutionized the management of numerous retinal diseases over the past decade
Results of clinical trials such as CATT (Comparison of AMD Treatments Trials), MANTA (Multicentre Anti-VEGF Trial in Austria), IVAN (The Inhibition of VEGF in Age-related choroidal Neovascularization), LUCAS (Lucentis Compared to Avastin Study), and GEFAL (Groupe d’Etude Français Avastin versus Lucentis ) showed the noninferiority of bevacizumab in comparison to ranibizumab with the same safety profile[2,3,4,5,6]
The 20 times lower cost of bevacizumab compared to ranibizumab and aflibercept makes this agent the most common anti-VEGFs used for intravitreal injection[7]
Summary
Introduction of anti-VEGFs has revolutionized the management of numerous retinal diseases over the past decade. How to cite this article: Mirshahi A, Lashay A, Riazi-Esfahani H, Ebrahimiadib N, Khojasteh H, Ghassemi F, Bazvand F, Khodabande A, Roohipour R, Khalili Pour E, Faghihi H. Intraocular Injection of Stivant® (A Biosimilar to Bevacizumab): A Case Series.
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