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Completed

NCT Number: NCT04621136

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

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).

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: GLANATEC ophthalmic solution 0.4%

Primary outcomes

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

    Time frame: throughout the study duration(up to week16)

    Safety Assessment

Secondary outcomes

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

    Time frame: week12 of treatment

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

  2. Proportion of patients with ROP remission in both eyes

    Time frame: week12 of treatment

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

  3. Concentration of ripasudil and its metabolite M1

    Time frame: throughout the study duration(up to week12)

    Pharmacokinetics, the population pharmacokinetic(popPK)

Sponsors and collaborators

Lead sponsor

Kyushu University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2020
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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