NCT04621136

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Kyushu University · Academic / Other
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2020-11-09
• Last updated: 2023-02-06

Locations

3 sites across 1 country: Japan