TY - JOUR
T1 - Comparing the Efficacy of Bevacizumab and Ranibizumab in Patients with Retinal Vein Occlusion
T2 - The Bevacizumab to Ranibizumab in Retinal Vein Occlusions (BRVO) study, a Randomized Trial
AU - Vader, Maartje J.C.
AU - Schauwvlieghe, Ann Sofie M.E.
AU - Verbraak, Frank D.
AU - Dijkman, Greetje
AU - Hooymans, Johanna M.M.
AU - Los, Leonoor I.
AU - Zwinderman, Aeilko H.
AU - Peto, Tunde
AU - Hoyng, Carel B.
AU - van Leeuwen, Redmer
AU - Vingerling, Johannes R.
AU - de Jong-Hesse, Yvonne
AU - van Lith-Verhoeven, Janneke J.C.
AU - Dijkgraaf, Marcel G.W.
AU - Schlingemann, Reinier O.
N1 - Funding Information:
Supported by ZonMw, The Netherlands Organization for Health Research and Development, The Hague, the Netherlands (grant no.: 171202018). The sponsor or funding organization had no role in the design or conduct of this research.
Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
PY - 2020/6
Y1 - 2020/6
N2 - Purpose: Comparing the efficacy of intravitreal injections of bevacizumab to ranibizumab in the treatment of macular edema (ME) resulting from retinal vein occlusion (RVO). Design: Comparative, randomized, double-masked, multicenter, noninferiority clinical trial. The noninferiority margin was 4 letters. Participants: Patients with vision loss resulting from ME secondary to a branch or (hemi) central RVO who might benefit from anti–vascular endothelial growth factor treatment were eligible for participation. Methods: From June 2012 through February 2018, 277 participants were randomized to receive injections of 1.25 mg bevacizumab (n = 139) or 0.5 mg ranibizumab (n = 138). The follow-up was 6 months with a monthly dosing interval. Main Outcome Measures: The primary outcome was a change in visual acuity from baseline at 6 months. Changes in the central area thickness and safety were studied as secondary outcomes. Results: The mean visual acuity (±standard deviation) improved, with 15.3±13.0 letters for bevacizumab and 15.5±13.3 letters for ranibizumab after 6 months of monthly treatment. The lower limit of the 2-sided 90% confidence interval was –1.724 letters, which is within the noninferiority margin of 4 letters. Even in the branch and (hemi-)central RVO subgroups, minimal differences were found in visual acuity outcomes between treatment arms. Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group. Severe adverse events (SAEs) were also distributed equally over both treatment groups: 10 participants (7.1%) in the bevacizumab group and 13 participants (9.2%) in the ranibizumab group experienced SAEs. Conclusions: This study showed, based on the change in visual acuity, that bevacizumab is noninferior to ranibizumab for patients with ME resulting from RVO of either subtype when receiving monthly injections for a period of 6 months. In addition, anatomic and safety outcomes did not differ between treatment groups. Based on our findings, bevacizumab may be an effective alternative to ranibizumab.
AB - Purpose: Comparing the efficacy of intravitreal injections of bevacizumab to ranibizumab in the treatment of macular edema (ME) resulting from retinal vein occlusion (RVO). Design: Comparative, randomized, double-masked, multicenter, noninferiority clinical trial. The noninferiority margin was 4 letters. Participants: Patients with vision loss resulting from ME secondary to a branch or (hemi) central RVO who might benefit from anti–vascular endothelial growth factor treatment were eligible for participation. Methods: From June 2012 through February 2018, 277 participants were randomized to receive injections of 1.25 mg bevacizumab (n = 139) or 0.5 mg ranibizumab (n = 138). The follow-up was 6 months with a monthly dosing interval. Main Outcome Measures: The primary outcome was a change in visual acuity from baseline at 6 months. Changes in the central area thickness and safety were studied as secondary outcomes. Results: The mean visual acuity (±standard deviation) improved, with 15.3±13.0 letters for bevacizumab and 15.5±13.3 letters for ranibizumab after 6 months of monthly treatment. The lower limit of the 2-sided 90% confidence interval was –1.724 letters, which is within the noninferiority margin of 4 letters. Even in the branch and (hemi-)central RVO subgroups, minimal differences were found in visual acuity outcomes between treatment arms. Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group. Severe adverse events (SAEs) were also distributed equally over both treatment groups: 10 participants (7.1%) in the bevacizumab group and 13 participants (9.2%) in the ranibizumab group experienced SAEs. Conclusions: This study showed, based on the change in visual acuity, that bevacizumab is noninferior to ranibizumab for patients with ME resulting from RVO of either subtype when receiving monthly injections for a period of 6 months. In addition, anatomic and safety outcomes did not differ between treatment groups. Based on our findings, bevacizumab may be an effective alternative to ranibizumab.
KW - Aged
KW - Angiogenesis Inhibitors/administration & dosage
KW - Bevacizumab/administration & dosage
KW - Dose-Response Relationship, Drug
KW - Double-Blind Method
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Intravitreal Injections
KW - Macular Edema/diagnosis
KW - Male
KW - Ranibizumab/administration & dosage
KW - Retinal Vein Occlusion/complications
KW - Retrospective Studies
KW - Tomography, Optical Coherence/methods
KW - Treatment Outcome
KW - Vascular Endothelial Growth Factor A/antagonists & inhibitors
KW - Visual Acuity
UR - http://www.scopus.com/inward/record.url?scp=85080067571&partnerID=8YFLogxK
U2 - 10.1016/j.oret.2019.12.019
DO - 10.1016/j.oret.2019.12.019
M3 - Article
C2 - 32107188
AN - SCOPUS:85080067571
VL - 4
SP - 576
EP - 587
JO - Ophthalmology Retina
JF - Ophthalmology Retina
IS - 6
ER -