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

Kyushu University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Retinopathy of Prematurity

Treatments

Drug: Ripasudil ophthalmic solution 0.4%

Study type

Interventional

Funder types

Other

Identifiers

NCT04621136

CTR180-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

24 patients

Sex

All

Ages

Under 4 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Informed consent signed by parents or legal guardians of the patient
1. Patients born with less than or equal to 32 weeks of gestational age and/or less than or equal to 1,500 grams of birth weight
1. Patients with the following types of ROP in both eyes
2. Zone I ROP with stage greater than or equal to 1
3. Zone II ROP with stage greater than or equal to 1

Exclusion criteria

1. Patients with aggressive posterior ROP in one or both eyes
1. Patients with type 1 ROP in one or both eyes
1. Patients with a confirmed or suspected chromosomal abnormality or genetic disorder
1. History of hypersensitivity to ripasudil (including drugs with similar chemical structure) in patients or their mothers
1. Patients or their mothers have participated in another intervention study and have used the study drug of another intervention study within 30 days prior to enrollment in this study or within 5 times the half-life of the study drug
1. Patients with an ocular structural abnormality that can affect the evaluation of this clinical study by investigators
1. Patients with a clinically significant neurological disease (e.g., intraventricular hemorrhage grade 3 or higher, severe hydrocephalus with significantly increased intracranial pressure)
1. Patients with inadequate blood access
1. Patients with complications, allergies, or worsening systemic conditions that make it difficult to conduct this trial
1. Patients judged unsuitable by investigators