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

NCT04621136 | Completed Phase 1 DMC

• 1 other identifier: CTR180-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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).

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity; ROP

Outcome Measures

Primary Outcomes (1)

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

  Safety Assessment

  throughout the study duration(up to week16)

Secondary Outcomes (3)

• Proportion of patients whose ROP worsens to Type1 ROP in one or both eyes

  week12 of treatment

• Proportion of patients with ROP remission in both eyes

  week12 of treatment

• Concentration of ripasudil and its metabolite M1

  throughout the study duration(up to week12)

Study Arms (1)

Ripasudil eye drops

EXPERIMENTAL

Ripasudil eye drops

Drug: Ripasudil ophthalmic solution 0.4%

Interventions

Ripasudil ophthalmic solution 0.4% 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.

Also known as: GLANATEC ophthalmic solution 0.4%

Ripasudil eye drops

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Informed consent signed by parents or legal guardians of the patient
• \. 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
• \. Patients with the following types of ROP in both eyes
• Zone I ROP with stage greater than or equal to 1
• Zone II ROP with stage greater than or equal to 1

You may not qualify if:

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

Sponsors & Collaborators

• Kyushu University: lead

Study Sites (3)

University Hospital of Occupational and Environmental Health

Kitakyushu, Fukuoka, 807-8555, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-850, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Related Publications (2)

• 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.

  PMID: 27124322 BACKGROUND

• 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.

  PMID: 34315793 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mitsuru Arima, MD,PhD

  Kyushu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center for Clinical and Translational Research

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)