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Study Protocol
Protocol for the SACLA trial: Efficacy and safety of subretinal monteplase for submacular hemorrhage in a phase II single-arm multicenter decentralized clinical trial
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Noriko Yoshida ,
Roles Conceptualization, Funding acquisition, Project administration, Writing – original draft, Writing – review & editing
* E-mail: nyoshida@cc.saga-u.ac.jp
Affiliation Clinical Research Center, Saga University Hospital, Saga, Japan
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Yuko Kobayakawa,
Roles Conceptualization, Funding acquisition, Project administration, Writing – original draft, Writing – review & editing
Affiliation Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan
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Kouta Funakoshi,
Roles Conceptualization, Funding acquisition, Software, Writing – original draft, Writing – review & editing
Affiliation Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan
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Sakiko Kimura,
Roles Project administration, Resources, Writing – review & editing
Affiliations Clinical Research Center, Saga University Hospital, Saga, Japan, Department of Pharmacy, Saga University Hospital, Saga, Japan
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Kazuhisa Hosoya,
Roles Project administration, Writing – review & editing
Affiliation Department of Pharmacy, Saga University Hospital, Saga, Japan
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Yuya Shinkawa,
Roles Data curation, Formal analysis, Writing – review & editing
Affiliation Clinical Research Center, Saga University Hospital, Saga, Japan
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Takuma Furukawa,
Roles Project administration, Writing – review & editing
Affiliation Department of Preventive Medicine, Faculty of Medicine, Saga University, Saga, Japan
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Tsubasa Mitsutake,
Roles Data curation, Writing – review & editing
Affiliation Education and Research Centre for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan
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Toshimi Hoshiko,
Roles Data curation, Writing – review & editing
Affiliations Department of Medical Technology and Science, Faculty of Fukuoka Health Care, International University of Health and Welfare, Fukuoka, Japan, Department of Hematology and Oncology, Saga University Hospital, Saga, Japan
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Ayako Takamori,
Roles Formal analysis, Writing – review & editing
Affiliation Clinical Research Center in Hiroshima, Hiroshima University Hospital, Hiroshima, Japan
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Naoto Kawahara,
Roles Methodology, Writing – review & editing
Affiliation Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan
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Hiroto Terasaki,
Roles Investigation, Writing – review & editing
Affiliation Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
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Akio Oishi,
Roles Investigation, Writing – review & editing
Affiliation Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan
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Hideki Koizumi,
Roles Investigation, Writing – review & editing
Affiliation Department of Ophthalmology, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan
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Toshihiro Inoue,
Roles Investigation, Writing – review & editing
Affiliation Department of Ophthalmology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan
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Atsunobu Takeda,
Roles Investigation, Writing – review & editing
Affiliation Department of Ophthalmology, Faculty of Medicine, Oita University, Ufu, Oita, Japan
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Yasuhiro Ikeda,
Roles Investigation, Writing – review & editing
Affiliation Department of Ophthalmology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
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Shigeo Yoshida,
Roles Investigation, Writing – review & editing
Affiliation Department of Ophthalmology, Kurume University School of Medicine, Kurume, Fukuoka, Japan
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Yuki Morizane,
Roles Methodology, Writing – review & editing
Affiliation Department of Ophthalmology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan
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Kazuaki Kadonosono,
Roles Methodology, Writing – review & editing
Affiliation Department of Ophthalmology, Yokohama City University Medical Center, Yokohama, Japan
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Makoto Inoue,
Roles Methodology, Writing – review & editing
Affiliation Kyorin Eye Center, Kyorin University School of Medicine, Mitaka, Japan
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Motohiro Kamei,
Roles Methodology, Writing – review & editing
Affiliation Department of Ophthalmology, Aichi Medical University, Nagakute, Japan
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Koji Todaka,
Roles Funding acquisition, Methodology, Writing – review & editing
Affiliation Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan
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Koh-Hei Sonoda,
Roles Investigation, Writing – review & editing
Affiliation Department of Ophthalmology, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan
⨯ - [ ... ],
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Hiroshi Enaida
Roles Investigation, Supervision, Writing – review & editing
Affiliation Department of Ophthalmology, Faculty of Medicine, Saga University, Saga, Japan
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Protocol for the SACLA trial: Efficacy and safety of subretinal monteplase for submacular hemorrhage in a phase II single-arm multicenter decentralized clinical trial
- Noriko Yoshida,
- Yuko Kobayakawa,
- Kouta Funakoshi,
- Sakiko Kimura,
- Kazuhisa Hosoya,
- Yuya Shinkawa,
- Takuma Furukawa,
- Tsubasa Mitsutake,
- Toshimi Hoshiko,
- Ayako Takamori
- Published: July 2, 2026
- https://doi.org/10.1371/journal.pone.0353127