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

NCT04621136 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-02-06

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Kyushu University

    lead OTHER

Principal Investigators

  • Mitsuru Arima, MD,PhD · Kyushu University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04621136 on ClinicalTrials.gov