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Study protocol for a multicentre, open-label, single-arm phase I/II trial to evaluate the safety and efficacy of ripasudil 0.4% eye drops for retinopathy of prematurity.

Mitsuru ArimaHirosuke InoueShintaro NakaoAkiko MisumiMaya SuzukiItsuka MatsushitaShunsuke ArakiChiemi YamashiroKazumasa TakahashiMasayuki OchiaiNoriko YoshidaMasayuki HiroseJunji KishimotoKoji TodakaShunji HasegawaKazuhiro KimuraKoichi KusuharaHiroyuki KondoShouichi OhgaKoh-Hei Sonoda
Published in: BMJ open (2021)
NCT04621136 and jRCT2071200047.
Keyphrases
  • open label
  • study protocol
  • phase iii
  • phase ii
  • clinical trial
  • randomized controlled trial
  • double blind
  • phase ii study
  • placebo controlled
  • squamous cell carcinoma
  • radiation therapy