Retinopathy of Prematurity Retinopathy of Prematurity, ROP
Conditions
Interventions
Phase I
A total of three infants will receive ripasudil eye drops once daily for one week, followed by twice-daily drug administration for two weeks. At the end of the three weeks of treatment for the
Eye drop administration
Sponsors
Arima Mitsuru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent signed by parents or legal guardians of the patient 2. 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 3. Patients with the following types of ROP in both eyes a. Zone I ROP with stage greater than or equal to 1 b. Zone II ROP with stage greater than or equal to 1
Exclusion criteria
Exclusion criteria: 1. Patients with aggressive posterior ROP in one or both eyes 2. Patients with type 1 ROP in one or both eyes 3. Patients with a confirmed or suspected chromosomal abnormality or genetic disorder 4. History of hypersensitivity to ripasudil (including drugs with similar chemical structure) in patients or their mothers 5. 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 6. Patients with an ocular structural abnormality that can affect the evaluation of this clinical study by investigators 7. Patients with a clinically significant neurological disease (e.g., intraventricular hemorrhage grade 3 or higher, severe hydrocephalus with significantly increased intracranial pressure) 8. Patients with inadequate blood access 9. Patients with complications, allergies, or worsening systemic conditions that make it difficult to conduct this trial 10. Patients judged unsuitable by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with AEs and ADRs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints 1. Efficacy a. Proportion of patients whose ROP worsens to type 1 ROP in one or both eyes (phase II) b. Proportion of patients with ROP remission in both eyes (phase II) 2. Pharmacokinetics of ripasudil (phase I and II) | — |
Contacts
Public ContactTsutomu Yamaguchi
Kyushu University Hospital
Outcome results
None listed