Clinical trial

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

Name

CTR180-01

Description

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).

Trial arms

Trial start

2020-11-01

Estimated PCD

2022-11-30

Trial end

2022-12-31

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Ripasudil eye drops

Other names:

GLANATEC ophthalmic solution 0.4%

Size

Primary endpoint

Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs)

throughout the study duration(up to week16)

Eligibility 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 1. Zone I ROP with stage greater than or equal to 1 2. Zone II ROP with stage greater than or equal to 1 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

Updated at

2023-02-06

1 organization

1 product

1 indication

Organization

Kyushu University

Product

Ripasudil

Indication

Retinopathy of Prematurity