PURPOSE: To report the results of intravitreal injection of a bevacizumab biosimilar called StivantⓇ. METHODS: This 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.
PURPOSE: To report the results of intravitreal injection of a bevacizumab biosimilar called StivantⓇ. METHODS: This 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.
Authors: Ravi Parikh; Joseph S Ross; Lindsey R Sangaralingham; Ron A Adelman; Nilay D Shah; Andrew J Barkmeier Journal: Ophthalmology Date: 2016-11-24 Impact factor: 12.079
Authors: Daniel F Martin; Maureen G Maguire; Gui-shuang Ying; Juan E Grunwald; Stuart L Fine; Glenn J Jaffe Journal: N Engl J Med Date: 2011-04-28 Impact factor: 91.245
Authors: Usha Chakravarthy; Simon P Harding; Chris A Rogers; Susan M Downes; Andrew J Lotery; Lucy A Culliford; Barnaby C Reeves Journal: Lancet Date: 2013-07-19 Impact factor: 79.321