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Prospective trial of treat-and-extend regimen with aflibercept for branch retinal vein occlusion: 1-year results of the PLATON trial

  • Retinal Disorders
  • Published:
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Abstract

Purpose

To evaluate the functional and anatomical outcomes of a treat-and-extend (TAE) regimen with aflibercept for treatment-naive macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

Methods

This was a prospective, multicenter, noncomparative, open-label clinical trial. Forty-eight eyes of 48 patients received three monthly intravitreal aflibercept injections prior to the TAE regimen. However, if the best-corrected visual acuity (BCVA) was ≥ 20/20 and the central macular thickness (CMT) was < 250 μm during the loading phase, the patient immediately proceeded to the TAE regimen. The treatment interval was adjusted by 4 weeks based on changes in CMT. The primary outcome was the mean change in BCVA from baseline to 52 weeks.

Results

The mean change in BCVA was 23.6 ± 14.2 letters. The proportion of patients with BCVA gain ≥ 15 letters was 77.1% at 24 weeks and 72.9% at 52 weeks. The mean reduction in CMT was 326.2 ± 235.6 μm at 24 weeks and 324.2 ± 238.0 μm at 52 weeks. The mean number of injections was 6.7 ± 1.2 (range: 6–11, all patients received three monthly intravitreal aflibercept injections) over 52 weeks, and 34 patients (70.8%) reached the maximal extension interval of 16 weeks at 52 weeks.

Conclusions

The TAE regimen using aflibercept for ME secondary to BRVO, which has a treatment interval of up to 16 weeks, showed comparable efficacy to the fixed-dosing regimen along with reduced treatment burden.

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Funding

This study was funded by Bayer Korea. The sponsor provided study drug and participated in review of the manuscript.

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Correspondence to Min Sagong.

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Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board (Yeungnam University Hospital IRB, Daegu, South Korea; Dong-A University Hospital IRB, Busan, South Korea; Chungnam National University Hospital IRB, Daejeon, South Korea; Maryknoll General Hospital IRB, Busan, South Korea; Chonnam National University Hospital IRB, Gwangju, South Korea), and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Conflict of interest

Author D.P. authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest, or non-financial interest in the subject matter or materials discussed in this manuscript. Author W.J. received a research grant from Bayer. Author J.P. received a research grant from Bayer. Author J.K. received a research grant from Bayer. Author Y.J. received a research grant from Bayer. Author M.S. received a research grant from Bayer, Novartis, and Allergan.

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Park, DG., Jeong, W.J., Park, J.M. et al. Prospective trial of treat-and-extend regimen with aflibercept for branch retinal vein occlusion: 1-year results of the PLATON trial. Graefes Arch Clin Exp Ophthalmol 259, 2879–2886 (2021). https://doi.org/10.1007/s00417-021-05150-y

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  • DOI: https://doi.org/10.1007/s00417-021-05150-y

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