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

Primary Purpose

Retinopathy of Prematurity

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Ripasudil ophthalmic solution 0.4%

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring Retinopathy of Prematurity, ROP

Eligibility Criteria

undefined - 4 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Occupational and Environmental Health
Yamaguchi University Hospital
Kyushu University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ripasudil eye drops

Arm Description

Ripasudil eye drops

Outcomes

Primary Outcome Measures

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

Safety Assessment

Secondary Outcome Measures

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

Efficacy Assessment： ripasudil-treated patients will be assessed in comparison to the medical records of a historical control group

Proportion of patients with ROP remission in both eyes

Efficacy Assessment： ripasudil-treated patients will be assessed in comparison to the medical records of a historical control group

Concentration of ripasudil and its metabolite M1

Pharmacokinetics, the population pharmacokinetic(popPK)

Full Information

NCT ID

NCT04621136

First Posted

November 4, 2020

Last Updated

February 3, 2023

Sponsor

Kyushu University

1. Study Identification

Unique Protocol Identification Number

NCT04621136

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

November 30, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyushu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity, ROP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ripasudil eye drops

Arm Type

Experimental

Arm Description

Ripasudil eye drops

Intervention Type

Drug

Intervention Name(s)

Ripasudil ophthalmic solution 0.4%

Other Intervention Name(s)

GLANATEC ophthalmic solution 0.4%

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Safety Assessment

Time Frame

throughout the study duration(up to week16)

Secondary Outcome Measure Information:

Title

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

Description

Efficacy Assessment： ripasudil-treated patients will be assessed in comparison to the medical records of a historical control group

Time Frame

week12 of treatment

Title

Proportion of patients with ROP remission in both eyes

Description

Efficacy Assessment： ripasudil-treated patients will be assessed in comparison to the medical records of a historical control group

Time Frame

week12 of treatment

Title

Concentration of ripasudil and its metabolite M1

Description

Pharmacokinetics, the population pharmacokinetic(popPK)

Time Frame

throughout the study duration(up to week12)

10. Eligibility

Sex

All

Maximum Age & Unit of Time

4 Months

Accepts Healthy Volunteers

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 Zone I ROP with stage greater than or equal to 1 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitsuru Arima, MD,PhD

Organizational Affiliation

Kyushu University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Occupational and Environmental Health

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

807-8555

Country

Japan

Facility Name

Yamaguchi University Hospital

City

Ube

State/Province

Yamaguchi

ZIP/Postal Code

755-850

Country

Japan

Facility Name

Kyushu University Hospital

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27124322

Citation

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.

Results Reference

background

PubMed Identifier

34315793

Citation

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.

Results Reference

derived

Learn more about this trial

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

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