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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 1, 2020

Primary Completion Date

November 30, 2022

Study Completion Date

December 31, 2022

Conditions
Retinopathy of Prematurity
Interventions
DRUG

Ripasudil ophthalmic solution 0.4%

"Phase1 A total of three infants will receive ripasudil eye drops(0.4%) once daily for one week, followed by twice-daily drug administration for two weeks. The three infants who participate in Phase1 can continue to receive the eye drop treatment for additional 9 weeks(12 weeks in total)if the investigators determine that there are no safety issues with ripasudil. In addition, a data and safety monitoring board(DSMB)will be held two times to decide whether the new patients can be enrolled into phase1, and also if phase2 can begin.~Phase2:A total of 21 patients will receive ripasudil eye drops(0.4%)twice daily for 12 weeks."

Trial Locations (3)

807-8555

University Hospital of Occupational and Environmental Health, Kitakyushu

755-850

Yamaguchi University Hospital, Ube

812-8582

Kyushu University Hospital, Fukuoka

All Listed Sponsors
lead

Kyushu University

OTHER

NCT04621136 - PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity | Biotech Hunter | Biotech Hunter