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Figures

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.

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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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