Bevacizumab vs Ranibizumab for Macular Edema Due to BRVO
Bevacizumab vs Ranibizumab for Macular Edema Due to BRVO
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.
Branch retinal vein occlusion (BRVO) is the second most common retinal vascular condition in adults. The Branch Vein Occlusion Study (BVOS) reported that over half (28/43) of all eyes with macular oedema due to BRVO treated with grid laser photocoagulation gained ≥2 lines of visual acuity (VA), compared with only a third (13/35) of untreated eyes. In 2009, the National Eye Institute-sponsored Standard Care versus Corticosteroid for Retinal Vein Occlusion trial demonstrated that intravitreal triamcinolone produced similar improvements in VA but with unacceptable rates of intraocular pressure elevation and concluded that grid laser photocoagulation should continue to be the standard of care. The Ranibizumab for Treatment of Macular Edema following BRVO (BRAVO) study, however, showed rapid and sustained visual improvement in patients who received monthly intravitreal (IVT) injections of 0.3 or 0.5 mg ranibizumab (Lucentis, Genentech, South San Francisco, California, USA/Roche, Basil, Switzerland). At the 6-month primary end point, the mean gains in best-corrected visual acuity (BCVA) were +16.6 and +18.3 letters in the 0.3 mg and 0.5 mg cohorts, respectively, compared with +7.3 letters in the sham/laser cohort. There was a significant difference in the number of subjects who gained ≥15 letters (61.1% with ranibizumab and 28.8% with sham). The phase III VIBRANT trial (Clinical Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Branch Retinal Vein Occlusion) showed that patients with macular oedema due to BRVO achieved similar improvements in VA when treated with aflibercept (Eylea, Regeneron, Tarrytown, New York, USA). As a result, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has become the standard of care for the treatment of macular oedema due to BRVO.
Bevacizumab (Avastin, Genentech, South San Francisco, California, USA/Roche, Basil, Switzerland) is a full-length, humanised, recombinant antibody that binds all isoforms of VEGF-A. Because bevacizumab binds VEGF with a similar mechanism of action to ranibizumab and is available at a much lower cost, it has been used off-label for the treatment of diabetic macular oedema and exudative age-related macular degeneration (AMD). In randomised comparison trials, bevacizumab was found to be non-inferior to ranibizumab for the treatment of age-related macular degeneration and diabetic macular oedema. To the best of our knowledge, however, there is no published prospective, randomised study comparing bevacizumab with ranibizumab for the treatment of macular oedema due to BRVO.
In this paper we report the 6-month outcomes of a randomised, double-masked, prospective, non-inferiority trial comparing the VA and central retinal thickness outcomes after intravitreal ranibizumab and bevacizumab in centre-involved macular oedema due to BRVO.
Abstract and Introduction
Abstract
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.
Introduction
Branch retinal vein occlusion (BRVO) is the second most common retinal vascular condition in adults. The Branch Vein Occlusion Study (BVOS) reported that over half (28/43) of all eyes with macular oedema due to BRVO treated with grid laser photocoagulation gained ≥2 lines of visual acuity (VA), compared with only a third (13/35) of untreated eyes. In 2009, the National Eye Institute-sponsored Standard Care versus Corticosteroid for Retinal Vein Occlusion trial demonstrated that intravitreal triamcinolone produced similar improvements in VA but with unacceptable rates of intraocular pressure elevation and concluded that grid laser photocoagulation should continue to be the standard of care. The Ranibizumab for Treatment of Macular Edema following BRVO (BRAVO) study, however, showed rapid and sustained visual improvement in patients who received monthly intravitreal (IVT) injections of 0.3 or 0.5 mg ranibizumab (Lucentis, Genentech, South San Francisco, California, USA/Roche, Basil, Switzerland). At the 6-month primary end point, the mean gains in best-corrected visual acuity (BCVA) were +16.6 and +18.3 letters in the 0.3 mg and 0.5 mg cohorts, respectively, compared with +7.3 letters in the sham/laser cohort. There was a significant difference in the number of subjects who gained ≥15 letters (61.1% with ranibizumab and 28.8% with sham). The phase III VIBRANT trial (Clinical Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Branch Retinal Vein Occlusion) showed that patients with macular oedema due to BRVO achieved similar improvements in VA when treated with aflibercept (Eylea, Regeneron, Tarrytown, New York, USA). As a result, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has become the standard of care for the treatment of macular oedema due to BRVO.
Bevacizumab (Avastin, Genentech, South San Francisco, California, USA/Roche, Basil, Switzerland) is a full-length, humanised, recombinant antibody that binds all isoforms of VEGF-A. Because bevacizumab binds VEGF with a similar mechanism of action to ranibizumab and is available at a much lower cost, it has been used off-label for the treatment of diabetic macular oedema and exudative age-related macular degeneration (AMD). In randomised comparison trials, bevacizumab was found to be non-inferior to ranibizumab for the treatment of age-related macular degeneration and diabetic macular oedema. To the best of our knowledge, however, there is no published prospective, randomised study comparing bevacizumab with ranibizumab for the treatment of macular oedema due to BRVO.
In this paper we report the 6-month outcomes of a randomised, double-masked, prospective, non-inferiority trial comparing the VA and central retinal thickness outcomes after intravitreal ranibizumab and bevacizumab in centre-involved macular oedema due to BRVO.
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