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A Trinity regimen with aflibercept for treatment-naïve neovascular age-related macular degeneration: 2-year outcomes

  • Retinal Disorders
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Abstract

Purpose

To evaluate the advantages of the Trinity regimen for treatment-naïve neovascular age-related macular degeneration (nAMD).

Methods

Thirty-one treatment–naïve nAMD eyes were treated using the Trinity regimen with an intravitreal aflibercept injection (IVA) and evaluated after 24 months. Three treatment methods, pro re nata (PRN), treat and extend (TAE), and fixed regimen were changed depending on recurrence frequency. After the initial treatment, PRN or TAE (started for 4 or 8 weeks) was selected as per the recurrence interval. Subsequently, the recurrence interval became constant, transitioning from a TAE to fixed regimen. When the recurrence frequency became irregular, the treatment regimen was changed to TAE.

Results

After the initial treatment, 15 eyes (48.4%) were allocated to the PRN group, 12 (38.7%) to the TAE 8-week group, and 4 (12.9%) to the TAE 4-week group. Mean logMAR significantly improved in all cases, 0.53 ± 0.40 at baseline to 0.36 ± 0.34 at 24 months (p < 0.01), in the PRN group (0.63 ± 0.46 to 0.42 ± 0.43, p < 0.01), and the TAE 8-week group (0.44 ± 0.29 to 0.27 ± 0.19, p < 0.05). LogMAR in the TAE 4-week group was maintained. The mean number of injections for all and in the PRN, TAE 8-week, and TAE 4-week groups were 9.7, 5.3, 13.1, and 15.8, respectively, with the PRN group being significantly less (p < 0.01).

Conclusion

The Trinity regimen delivered the benefits of the PRN, TAE, and FIXED regimens while minimizing injections during the early treatment phase without visual loss.

Trial registration

This trial was registered with the University Hospital Medical Information Network (UMIN ID: 000038335).

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Authors and Affiliations

  1. Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan

    Makiko Wakuta, Tadahiko Ogata, Manami Ota, Chiemi Yamashiro, Makoto Hatano, Ryoji Yanai, Kazuhiro Tokuda & Kazuhiro Kimura

  2. Ube-Kohsan Central Hospital, Ube, Japan

    Makiko Wakuta

  3. JCHO Shimonoseki Medical Center, Shimonoseki, Japan

    Nanami Nomi

Authors
  1. Makiko Wakuta
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  2. Nanami Nomi
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  3. Tadahiko Ogata
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  4. Manami Ota
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  5. Chiemi Yamashiro
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  6. Makoto Hatano
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  7. Ryoji Yanai
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  8. Kazuhiro Tokuda
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  9. Kazuhiro Kimura
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Makiko Wakuta, Nanami Nomi, Tadahiko Ogata, Manami Ota and Chiemi Yamashiro. The first draft of the manuscript was written by Makiko Wakuta and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Kazuhiro Kimura.

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The authors declare that they have no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board of the Yamaguchi University School of Medicine and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The institutional review board approved the use of an opt-out consent method.

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Wakuta, M., Nomi, N., Ogata, T. et al. A Trinity regimen with aflibercept for treatment-naïve neovascular age-related macular degeneration: 2-year outcomes. Graefes Arch Clin Exp Ophthalmol 258, 1663–1670 (2020). https://doi.org/10.1007/s00417-020-04745-1

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  • DOI: https://doi.org/10.1007/s00417-020-04745-1

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