Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial
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Le résumé fourni par la source
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).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial
- Date Crossref
- 01/04/2026
- Éditeur
- BMJ
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Kyoto University Department of Clinical Innovative Medicine Institute for Advancement of Clinical and Translational Science (iACT) pays non établi dans la noticeUniversité ou école supérieure
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Chiba University pays non établi dans la noticeUniversité ou école supérieure
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Tokyo Women's Medical University Department of Ophthalmology pays non établi dans la noticeUniversité ou école supérieure
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Kansai Medical University Department of Ophthalmology pays non établi dans la noticeUniversité ou école supérieure
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Kyoto University Hospital pays non établi dans la noticeÉtablissement de santé
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Wakayama Medical University pays non établi dans la noticeUniversité ou école supérieure
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Kagoshima University Department of Ophthalmology pays non établi dans la noticeUniversité ou école supérieure
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Japan Community Healthcare Organization pays non établi dans la noticeOrganisme public
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Graduate School of Medicine Department of Ophthalmology and Visual Sciences pays non établi dans la noticeUniversité ou école supérieure
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School of Pharmaceutical Sciences pays non établi dans la noticeUniversité ou école supérieure
Department of Clinical Innovative Medicine Institute for Advancement of Clinical and Translational Science (iACT) — Kyoto University, Chiba University et Department of Ophthalmology — Tokyo Women's Medical University, avec 7 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.