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PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

Official title:
PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity

Clinical Trial Summary

This is an open-label, single-arm phase I/II trial to evaluate the safety and efficacy of Rho-associated protein kinase(ROCK) inhibitor Ripasudil eye drops for preterm infants with Retinopathy of Prematurity(ROP).

Clinical Trial Description

Ripasudil eye drops will be administrated to all enrolled preterm infants with zone I/II stage 1 or greater ROP （except for aggressive posterior ROP, Type1 ROP ）. The safety and efficacy of ripasudil in treated patients will be assessed in comparison to a historical control. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04621136
Study type Interventional
Source Kyushu University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date November 1, 2020
Completion date December 31, 2022
View Details
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