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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
University Hospital of Occupational and Environmental Health
Kitakyushu, Fukuoka, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Kyushu University Hospital
Fukuoka, Japan
Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs)
Safety Assessment
Time frame: throughout the study duration(up to week16)
Proportion of patients whose ROP worsens to Type1 ROP in one or both eyes
Efficacy Assessment: ripasudil-treated patients will be assessed in comparison to the medical records of a historical control group
Time frame: week12 of treatment
Proportion of patients with ROP remission in both eyes
Efficacy Assessment: ripasudil-treated patients will be assessed in comparison to the medical records of a historical control group
Time frame: week12 of treatment
Concentration of ripasudil and its metabolite M1
Pharmacokinetics, the population pharmacokinetic(popPK)
Time frame: throughout the study duration(up to week12)
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