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

NCT ID: NCT04621136

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ripasudil eye drops

Ripasudil eye drops

Group Type: EXPERIMENTAL

Ripasudil ophthalmic solution 0.4%

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

GLANATEC ophthalmic solution 0.4%

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

• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyushu University

OTHER

Sponsor Role: lead

Responsible Party

Mitsuru Arima

Center for Clinical and Translational Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitsuru Arima, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Kyushu University Hospital

Locations

University Hospital of Occupational and Environmental Health

Kitakyushu, Fukuoka, Japan

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Kyushu University Hospital

Fukuoka, , Japan

Countries

Japan

References

Yamaguchi M, Nakao S, Arita R, Kaizu Y, Arima M, Zhou Y, Kita T, Yoshida S, Kimura K, Isobe T, Kaneko Y, Sonoda KH, Ishibashi T. Vascular Normalization by ROCK Inhibitor: Therapeutic Potential of Ripasudil (K-115) Eye Drop in Retinal Angiogenesis and Hypoxia. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):2264-76. doi: 10.1167/iovs.15-17411.

Reference Type: BACKGROUND

PMID: 27124322 (View on PubMed)

Arima M, Inoue H, Nakao S, Misumi A, Suzuki M, Matsushita I, Araki S, Yamashiro C, Takahashi K, Ochiai M, Yoshida N, Hirose M, Kishimoto J, Todaka K, Hasegawa S, Kimura K, Kusuhara K, Kondo H, Ohga S, Sonoda KH. Study protocol for a multicentre, open-label, single-arm phase I/II trial to evaluate the safety and efficacy of ripasudil 0.4% eye drops for retinopathy of prematurity. BMJ Open. 2021 Jul 27;11(7):e047003. doi: 10.1136/bmjopen-2020-047003.

Reference Type: DERIVED

PMID: 34315793 (View on PubMed)

Other Identifiers

CTR180-01

Identifier Type: -

Identifier Source: org_study_id