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Real-world management of treatment-naïve diabetic macular oedema: 2-year visual outcome focusing on the starting year of intervention from STREAT-DMO study
  1. Masahiko Shimura1,
  2. Shigehiko Kitano2,
  3. Daisuke Muramatsu3,
  4. Harumi Fukushima2,
  5. Yoshihiro Takamura4,
  6. Makiko Matsumoto5,
  7. Masahide Kokado6,
  8. Jiro Kogo7,
  9. Mariko Sasaki8,9,
  10. Yuki Morizane10,
  11. Takuya Utsumi1,
  12. Takashi Koto11,
  13. Shozo Sonoda12,
  14. Takao Hirano13,
  15. Hiroto Ishikawa14,
  16. Yoshinori Mitamura15,
  17. Fumiki Okamoto16,
  18. Takamasa Kinoshita17,
  19. Kazuhiro Kimura18,
  20. Masahiko Sugimoto19,
  21. Kenji Yamashiro20,
  22. Yukihiko Suzuki21,
  23. Taiichi Hikichi22,
  24. Noriaki Washio23,
  25. Tomohito Sato24,
  26. Kishiko Ohkoshi25,
  27. Hiroki Tsujinaka26,
  28. Sentaro Kusuhara27,
  29. Mineo Kondo19,
  30. Hitoshi Takagi7,
  31. Toshinori Murata13,
  32. Taiji Sakamoto12
  33. on behalf of Japan Clinical Retina Study (J-CREST) group
    1. 1Department of Ophthalmology, Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan
    2. 2Diabetes Center, Tokyo Women's Medical University School of Medicine, Shinjuku-ku, Tokyo, Japan
    3. 3Department of Ophthalmology, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan
    4. 4Department of Ophthalmology, University of Fukui, Yoshida, Japan
    5. 5Department of Ophthalmology, Nagasaki University School of Medicine Graduate School of Biomedical Sciences, Nagasaki, Japan
    6. 6Department of Ophthalmology, Wakayama Medical University, Wakayama, Japan
    7. 7Department of Ophthalmology, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan
    8. 8Department of Ophthalmology, Tachikawa Hospital, Tachikawa, Japan
    9. 9Department of Ophthalmology, National Hospital Organisation Tokyo Medical Center, Meguro-ku, Tokyo, Japan
    10. 10Department of Ophthalmology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
    11. 11Kyorin Eye Center, Kyorin University School of Medicine, Mitaka, Tokyo, Japan
    12. 12Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
    13. 13Deparment of Ophthalmology, Shinshu University School of Medicine, Matsumoto, Nagano, Japan
    14. 14Department of Ophthalmology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
    15. 15Department of Ophthalmology, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Tokushima, Japan
    16. 16Department of Ophthalmology, University of Tsukuba Faculty of Medicine, Tsukuba, Ibaraki, Japan
    17. 17Department of Ophthalmology, Sapporo City General Hospital, Sapporo, Japan
    18. 18Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan
    19. 19Department of Ophthalmology, Mie University Graduate School of Medicine, Tsu, Mie, Japan
    20. 20Department of Ophthalmology, Japanese Red Cross Otsu Hospital, Otsu, Japan
    21. 21Department of Ophthalmology, Hirosaki University School of Medicine Graduate School of Medicine, Hirosaki, Aomori, Japan
    22. 22Hikichi Eye Clinic, Sapporo, Hokkaido, Japan
    23. 23Department of Ophthalmology, Showa General Hospital, Kodaira, Tokyo, Japan
    24. 24Department of Ophthalmology, National Defense Medical College, Tokorozawa, Saitama, Japan
    25. 25Department of Ophthalmology, St. Luke's International Hospital, Tokyo, Japan
    26. 26Department of Ophthalmology, Nara Medical University, Kashihara, Nara, Japan
    27. 27Department of Surgery Related, Division of Ophthalmology, Kobe University Graduate School of Medicine, Kobe, Japan
    1. Correspondence to Professor Masahiko Shimura, Department of Ophthalmology, Tokyo Medical University Hachioji Medical Center, Hachioji 1930998, Japan; masahiko{at}v101.vaio.ne.jp

    Abstract

    Background/aims To investigate the yearly change of real-world outcomes for best corrected visual acuity (BCVA) after 2-year clinical intervention for treatment-naïve diabetic macular oedema (DMO).

    Methods Retrospective analysis of aggregated, longitudinal medical records obtained from 27 retina specialised institutions in Japan from Survey of Treatment for DMO database. A total of 2049 treatment-naïve centre involving DMO eyes of which the initial intervention started between 2010 and 2015, and had been followed for 2 years, were eligible. As interventions, antivascular endothelial growth factor (VEGF) agents, local corticosteroids, macular photocoagulation and vitrectomy were defined. In each eye, baseline and final BCVA, the number of each intervention for 2 years was extracted. Each eye was classified by starting year of interventional treatment.

    Results Although baseline BCVA did not change by year, 2-year improvement of BCVA had been increased, and reached to +6.5 letters in the latest term. There is little difference among starting year about proportions of eyes which BCVA gained >15 letters, in contrast to those which lost >15 letters were decreased by year. The proportion of eyes receiving anti-VEGF therapy was dramatically increased, while those receiving the other therapies were gradually decreased. The proportion of eyes which maintained socially good vision of BCVA>20/40 has been increased and reached to 59.0% in the latest term.

    Conclusion For recent years, treatment patterns for DMO have been gradually but certainly changed; as a result, better visual gain, suppression of worsened eyes and better final BCVA have been obtained. Anti-VEGF therapy has become the first-line therapy and its injection frequency has been increasing.

    • epidemiology
    • macula
    • retina
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    Footnotes

    • Collaborators Japan Clinical Retina Study (J-CREST) group: Statistical analysis: Katsunori Shimada PhD in STATZ Institute Inc. Contributions of the authors by data acquisition: Hidetaka Noma MD, Ryosuke Motohashi MD, Osamu Kotake MD and Makoto Imazeki MD in Department of Ophthalmology, Tokyo Medical University, Hachioji Medical Center. Eiko Tsuzuki MD in Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Nagasaki University. Shizuya Saika MD in Department of Ophthalmology, Wakayama Medical University. Ryutaro Yamanishi MD in Department of Ophthalmology, National Tokyo Medical Center. Takao Kashiwagi MD and Fumi Gomi MD in Department of Ophthalmology, Hyogo College of Medicine. Takashi Katome MD in Department of Ophthalmology, Institute of Biomedical Sciences, Tokushima University Graduate School. Keiichi Nishikawa MD in Department of Ophthalmology, Japanese Red Cross Otsu Hospital. Mitsuru Nakazawa MD in Department of Ophthalmology, Hirosaki University Graduate School of Medicine. Masaru Takeuchi MD in Department of Ophthalmology, National Defense Medical College. Nahoko Ogata MD in Department of Ophthalmology, Nara Medical University.

    • Funding This study was supported by clinical research grant-in aid by Tokyo Medical University. This study is registered with the University Hospital Medical Information Network individual case data repository (UMIN#23160).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The study protocol was reviewed and approved by the Institutional Review Board of each participating centre.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request. All data were stored and managed in a statistical institution and available upon reasonable request.

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