Governance and Safety Monitoring

Risks & contraindications

Other

Highlighted claims

• The trial has IRB approval from all four participating institutions under approval number K101. — Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial
• The trial complies with the Declaration of Helsinki and Japan's Clinical Trials Act Good Clinical Practice. — Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial
• An independent DSMB reviews serious adverse events and study progress. — Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial
• The DSMB can recommend pausing or terminating the trial on safety grounds. — Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial
• Emergency unblinding is available when clinically necessary for participant care. — Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial
• Results will be published and presented regardless of outcome. — Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial
• Data management and statistical analysis are conducted by iACT at Kyoto University. — Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial