PURPOSE: To assess the efficacy and safety of intravitreal bevacizumab (IVB) compared with ranibizumab (IVR) in the treatment of macular oedema due to branch retinal vein occlusion (BRVO). METHODS: In this prospective, randomised, non-inferiority trial, 75 participants with macular oedema due to BRVO received intravitreal injections ofranibizumab or bevacizumab after 1:1 block randomisation. The primary outcome measure was the difference in mean changes in best-corrected visual acuity (BCVA) at 6 months. Secondary outcome measures included mean change in central retinal thickness (CRT), the proportion of patients improving by >15 letters and the proportion of patients developing neovascularisation. RESULTS: Participants received either IVR (n=37) or IVB (n=38). The mean BCVA at baseline was 52.8±14.4 letters (20/80) and 56.1±10.0 letters (20/80) (p=0.24) in the ranibizumab and bevacizumab groups, respectively. At 6 months, the mean gains in BCVA were +18.1 letters (p<0.0001; 95% CI, +12.8 to +22.6) in the ranibizumab group and +15.6 letters (p<0.0001; 95% CI +12.0 to +20.5) in the bevacizumab group. The difference between the mean visual gains of the treated groups (bevacizumab-ranibizumab) was -2.5 letters (95% CI -8.0 to +5.0; p=0.74). Mean reductions in CRT at 6 months were 177.1±122.3 µm in the ranibizumab group (p<0.0001) and 201.7±166.2 µm in the bevacizumab group (p<0.0001), with no significant difference between the two groups (p=0.48). The mean numbers of ranibizumab and bevacizumab injections were 3.2±1.5 and 3.0±1.4, respectively (p=0.55). Two serious adverse events occurred in the ranibizumab group and one in the bevacizumab group but both were unrelated to intravitreal injections. CONCLUSIONS: This study demonstrated significant gain in visual acuity in eyes with BRVO treated with eitherbevacizumab or ranibizumab. Pro-re-nata strategy was effective in maintaining the visual gain. TRIAL REGISTRATION NUMBER: http://www.ctri.nic.in/ CTRI/2012/01/003120. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
PURPOSE: To assess the efficacy and safety of intravitreal bevacizumab (IVB) compared with ranibizumab (IVR) in the treatment of macular oedema due to branch retinal vein occlusion (BRVO). METHODS: In this prospective, randomised, non-inferiority trial, 75 participants with macular oedema due to BRVO received intravitreal injections of ranibizumab or bevacizumab after 1:1 block randomisation. The primary outcome measure was the difference in mean changes in best-corrected visual acuity (BCVA) at 6 months. Secondary outcome measures included mean change in central retinal thickness (CRT), the proportion of patients improving by >15 letters and the proportion of patients developing neovascularisation. RESULTS:Participants received either IVR (n=37) or IVB (n=38). The mean BCVA at baseline was 52.8±14.4 letters (20/80) and 56.1±10.0 letters (20/80) (p=0.24) in the ranibizumab and bevacizumab groups, respectively. At 6 months, the mean gains in BCVA were +18.1 letters (p<0.0001; 95% CI, +12.8 to +22.6) in the ranibizumab group and +15.6 letters (p<0.0001; 95% CI +12.0 to +20.5) in the bevacizumab group. The difference between the mean visual gains of the treated groups (bevacizumab-ranibizumab) was -2.5 letters (95% CI -8.0 to +5.0; p=0.74). Mean reductions in CRT at 6 months were 177.1±122.3 µm in the ranibizumab group (p<0.0001) and 201.7±166.2 µm in the bevacizumab group (p<0.0001), with no significant difference between the two groups (p=0.48). The mean numbers of ranibizumab and bevacizumab injections were 3.2±1.5 and 3.0±1.4, respectively (p=0.55). Two serious adverse events occurred in the ranibizumab group and one in the bevacizumab group but both were unrelated to intravitreal injections. CONCLUSIONS: This study demonstrated significant gain in visual acuity in eyes with BRVO treated with either bevacizumab or ranibizumab. Pro-re-nata strategy was effective in maintaining the visual gain. TRIAL REGISTRATION NUMBER: http://www.ctri.nic.in/ CTRI/2012/01/003120. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Yongseok Mun; ChulHyoung Park; Da Yun Lee; Tong Min Kim; Ki Won Jin; Seok Kim; Yoo-Ri Chung; Kihwang Lee; Ji Hun Song; Young-Jung Roh; Donghyun Jee; Jin-Woo Kwon; Se Joon Woo; Kyu Hyung Park; Rae Woong Park; Sooyoung Yoo; Dong-Jin Chang; Sang Jun Park Journal: Sci Rep Date: 2022-06-17 Impact factor: 4.996