Comparing the efficacy of bevacizumab and ranibizumab in patients with retinal vein occlusion: the BRVO study, a randomized trial
Affiliations
- Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
Affiliations
- Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
Affiliations
- Department of Ophthalmology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Affiliations
- Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands
Affiliations
- Department of Ophthalmology, University Medical Center Groningen and W.J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, the Netherlands
Affiliations
- Department of Ophthalmology, University Medical Center Groningen and W.J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, the Netherlands
Affiliations
- Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
Affiliations
- Department of Ophthalmology, Queens University Belfast, Belfast, United Kingdom
Affiliations
- Department of Ophthalmology, Radboud University Medical Center, Nijmegen, the Netherlands
Affiliations
- Department of Ophthalmology, University Medical Center Utrecht, Utrecht, the Netherlands
Affiliations
- Department of Ophthalmology, Erasmus University Medical Center, Rotterdam, the Netherlands
Affiliations
- Department of Ophthalmology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Affiliations
- Department of Ophthalmology, Elisabeth – Twee Steden (ETZ) Hospital, Tilburg, the Netherlands
Affiliations
- Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
Affiliations
- Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
- Department of Ophthalmology, University of Lausanne, Jules-Gonin Eye Hospital, Lausanne, Switzerland
Correspondence
- Corresponding author Reinier O. Schlingemann, MD, PhD, Department of Ophthalmology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
Correspondence information about the author Reinier O. SchlingemannAffiliations
- Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
- Department of Ophthalmology, University of Lausanne, Jules-Gonin Eye Hospital, Lausanne, Switzerland
Correspondence
- Corresponding author Reinier O. Schlingemann, MD, PhD, Department of Ophthalmology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
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Figure 1
Mean change in visual acuity from baseline to 6 months. a. Whole cohort. b. Patients with an initial visual acuity of ≤62 letters. c. Patients with an initial visual acuity of ≥63 letters. CI = confidence interval.
Figure 2
Mean change in central area thickness from baseline to 6 months. a. Whole cohort. b. Patients with an initial visual acuity ≤62 letters. c. Patients with an initial visual acuity ≥63 letters.
Figure 3
The two-sided 90% confidence intervals, with a non-inferiority margin of 4 letters. Bevacizumab could be considered non-inferior in both the whole cohort and patients with a baseline visual acuity of ≤62 letters. The outcomes for the group with an initially higher baseline visual acuity are inconclusive. BCVA = best corrected visual acuity.
Abstract
Purpose
We compared the efficacy of intravitreal injections of bevacizumab compared to ranibizumab in the treatment of macular edema due to retinal vein occlusion.
Design
This was a comparative, randomized, double-masked, multicenter, non-inferiority clinical trial. The non-inferiority margin was 4 letters.
Participants
Patients with vision loss due to macular edema secondary to a branch or (hemi) central retinal vein occlusion who might benefit from anti- vascular endothelial growth factor (VEGF) treatment were eligible for participation.
Methods
From June 2012 to 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 time 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 two-sided 90% confidence interval was -1.724 letters, which is within the non-inferiority margin of 4 letters. Even in the branch and (hemi-)central vein occlusion subgroups, minimal differences were found in visual acuity outcomes between treatment arms. Changes in central area thickness on optical coherence tomography 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 equally distributed over both treatment groups, as 10 participants (7.1%) in the bevacizumab group and 13 participants (9.2%) in the ranibizumab group suffered SAEs.
Conclusion
This study shows, based on the change in visual acuity, that bevacizumab is non-inferior to ranibizumab for patients with macular edema due to retinal vein occlusion of either subtype, when receiving monthly injections for a period of 6 months. In addition, anatomical and safety outcomes did not differ between treatment groups. Based on our findings, bevacizumab may be an effective alternative to ranibizumab.
Abbreviations and Acronyms:
AMD (age related macular degeneration), BCVA (best corrected visual acuity), BRVO (branch retinal vein occlusion), CI (confidence interval), CRVO (central retinal vein occlusion), DME (diabetic macular edema), DRCR.net (Diabetic Retinopathy Clinical Research Network), ETDRS (Early Treatment of Diabetic Retinopathy Study), FA (fluorescein angiogram), hemi-CRVO (hemi-central retinal vein occlusion), IOP (intraocular pressure), IRB (Institutional Review Board), ME (macular edema), MedDRA (Medical Dictionary for Regulatory Activities), OCT (optical coherence tomography), RCT (randomized clinical trial), RVO (retinal vein occlusion), SAE (adverse event), SD (standard deviation), VEGF (vascular endothelial growth factor)To access this article, please choose from the options below
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The data presented in this manuscript were partly presented at the annual Dutch Ophthalmology Association Meeting, Maastricht, The Netherlands, March 29, 2019, and at the EURETINA 9th Winter Meeting, March 1-2, 2019.
Financial support
Supported by ZonMw, The Netherlands Organization for Health Research and Development, The Hague, the Netherlands, Grant 171202018. The sponsor or funding organization had no role in the design or conduct of this research.
Conflict of interest
T.P.: Consultant – Novartis, OPTOS, Heidelberg. Y.J.H.: Speakers fee – Novartis. J.J.C.L.V.: Advisory board – Novartis. R.O.S.: Consultant - Oxurion, IDx; Conference support - Novartis, Bayer, Optos.
No conflicting relationships exist for other authors.
Bevacizumab and Ranibizumab for Retinal Vein Occlusion
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