{
  "abstract": "Introduction Chronic central serous chorioretinopathy (CSC) can cause progressive and permanent vision loss. Although photodynamic therapy (PDT) is a primary treatment option globally, it is not approved for CSC worldwide, limiting therapeutic access. The REPLAY trial is a phase III, investigator-initiated trial to evaluate the efficacy and safety of reduced-fluence PDT (rf-PDT) for chronic CSC to seek the first regulatory approval globally.Methods and analysis This study comprises two cohorts. The ‘untreated cohort’ is a multicentre, randomised, placebo-controlled, double-masked trial involving 60 patients with untreated, fovea-involving chronic CSC, randomised 2:1 to receive a single rf-PDT or placebo treatment. The ‘previously treated cohort’ is a single-arm, open-label trial for up to 10 patients with recurrent CSC after PDT. The primary endpoint for both cohorts is the proportion of eyes with a complete resolution of subfoveal fluid at 12 weeks post-treatment, assessed by optical coherence tomography. Secondary endpoints include changes in best-corrected visual acuity, central choroidal thickness, recurrence rates and incidence of adverse events over a 48 week follow-up.Ethics and dissemination The study protocol was approved by the Kyoto University Hospital Institutional Review Board, IRB of Chiba University Hospital, Tokyo Women’s Medical University Institutional Review Board and Institutional Review Board of Kansai Medical University Hospital. Written informed consent is obtained from all participants. The results will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences.Trial registration number jRCT2051230156 (URL: https://jrct.mhlw.go.jp/latest-detail/jRCT2051230156).",
  "authors": [
    {
      "affiliations": [
        "Department of Ophthalmology and Visual Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Masahiro Miyake"
    },
    {
      "affiliations": [
        "Department of Ophthalmology and Visual Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Ayako Takahashi"
    },
    {
      "affiliations": [
        "Department of Ophthalmology and Visual Science, Graduate School of Medicine, Chiba University, Chiba, Japan"
      ],
      "name": "Takayuki Baba"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Tokyo Women’s Medical University, Shinjuku, Tokyo, Japan"
      ],
      "name": "Ichiro Maruko"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Kansai Medical University, Hirakata, Japan"
      ],
      "name": "Masayuki Ohnaka"
    },
    {
      "affiliations": [
        "Department of Clinical Innovative Medicine Institute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, Kyoto, Japan"
      ],
      "name": "Akiko Kuroda"
    },
    {
      "affiliations": [
        "Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Harue Tada"
    },
    {
      "affiliations": [
        "Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Yu Hidaka"
    },
    {
      "affiliations": [
        "Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Yumiko Ibi"
    },
    {
      "affiliations": [
        "Department of Ophthalmology and Visual Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Yuki Muraoka"
    },
    {
      "affiliations": [
        "School of Pharmaceutical Sciences, Wakayama Medical University, Wakayama, Japan"
      ],
      "name": "Tatsuya Ito"
    },
    {
      "affiliations": [
        "Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Satoshi Morita"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Kagoshima University, Kagoshima, Japan"
      ],
      "name": "Taiji Sakamoto"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Kansai Medical University, Hirakata, Japan"
      ],
      "name": "Hisanori Imai"
    },
    {
      "affiliations": [
        "Department of Ophthalmology and Visual Science, Graduate School of Medicine, Chiba University, Chiba, Japan",
        "Japan Community Healthcare Organization, Tokyo, Japan"
      ],
      "name": "Shuichi Yamamoto"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Tokyo Women’s Medical University, Shinjuku, Tokyo, Japan"
      ],
      "name": "Tomohiro Iida"
    },
    {
      "affiliations": [
        "Department of Ophthalmology and Visual Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Akitaka Tsujikawa"
    }
  ],
  "title": "Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial",
  "uid": "210474d8-6178-506f-8417-f7c11c64f672"
}