June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Comparison of ziv-aflibercept and bevacizumab for treatment of naïve central retinal vein occlusion with macular edema: interim analysis of a randomized non-inferiority trial
Author Affiliations & Notes
  • Kwanchanok Chanthowong
    Ophthalmology, Khon Kaen University Faculty of Medicine, Khon Kaen, Khon Kaen, Thailand
  • Suthasinee Sinawat
    Ophthalmology, Khon Kaen University Faculty of Medicine, Khon Kaen, Khon Kaen, Thailand
  • Yosanan Yoipaiboon
    Ophthalmology, Khon Kaen University Faculty of Medicine, Khon Kaen, Khon Kaen, Thailand
  • Suthasinee Hemanak
    Ophthalmology, Khon Kaen University Faculty of Medicine, Khon Kaen, Khon Kaen, Thailand
  • Footnotes
    Commercial Relationships   Kwanchanok Chanthowong None; Suthasinee Sinawat None; Yosanan Yoipaiboon None; Suthasinee Hemanak None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 3743 – F0164. doi:
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      Kwanchanok Chanthowong, Suthasinee Sinawat, Yosanan Yoipaiboon, Suthasinee Hemanak; Comparison of ziv-aflibercept and bevacizumab for treatment of naïve central retinal vein occlusion with macular edema: interim analysis of a randomized non-inferiority trial. Invest. Ophthalmol. Vis. Sci. 2022;63(7):3743 – F0164.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Macular edema (ME) is the most common visual threatening complication of central retinal vein occlusion (CRVO) due to an increased level of vascular endothelial growth factors (VEGF). Considering the high cost of other anti-VEGF, bevacizumab is the most used anti-VEGF for ME in real-world practice. Ziv-aflibercept, an anti-VEGF with similar molecules with aflibercept, is now available for off-label ophthalmic use. This study hypothesized that intravitreal ziv-aflibercept (IVZ) is non-inferior to intravitreal bevacizumab (IVB) as the treatment of ME in CRVO.

Methods : The participants who were diagnosed with ME from CRVO were randomly assigned 1:1 to receive IVZ (1.25 mg/0.05ml) or IVB (1.25 mg/0.05ml) at baseline, 1, and 2 months. Later the participants were followed once every month until 6 months. Additional intravitreal injection of allocated drug was given as a pro-re-nata protocol for recurrent or persistent ME. The primary outcome was the best-corrected visual acuity (BCVA) change from baseline. Mean change in central subfield thickness (CST), the number of injections and adverse events were considered as secondary outcomes.

Results : 22 of 26 participants had completed 6 months follow-up, 11 in each group. The initial mean BCVA was 1.13±0.57 logMAR in IVZ cohort and 1.17±0.59 log MAR in IVB cohort. The initial mean CST was 738.42±264.97 µm and 756.93±262.51 µm in IVZ and IVB, respectively. Baseline characteristics were well balanced between each treatment group. At the endpoint, no statistically significant difference was observed in both visual (mean difference in BCVA change 0.21 log MAR, 95% CI -0.29-0.7, p=0.389) and anatomical outcome (mean difference in CST change 64.53 µm, 95% CI -97.78-171.42, p=0.573) between 2 groups. Although the mean number of injections was less in IVZ group (4.5+1.3) than IVB group (4.8+1.3), there was no statistically significant (p=0.68). No sign of intraocular inflammation, increase lens opacity and IOP elevation and serious systemic adverse events were observed.

Conclusions : Interim results demonstrated that ziv-aflibercept had comparable visual and anatomical outcomes with bevacizumab for treatment of CRVO with ME at 6-months of follow-up. Ziv-aflibercept was safe and efficacious; therefore enrollment to 42 patients should be continued.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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