Trial · NCT04621136
PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
NCT04621136, Phase 1, Phase 2, Completed, Kyushu University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity. Trials, record NCT04621136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04621136
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
- NCT number
- NCT04621136
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Kyushu University
- Conditions
- Retinopathy of Prematurity
- Interventions
- Ripasudil ophthalmic solution 0.4%
- First posted
- 2020-11-09
- Last updated
- 2023-02-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs) | throughout the study duration(up to week16) | Safety Assessment |
| Secondary | Proportion of patients whose ROP worsens to Type1 ROP in one or both eyes | week12 of treatment | Efficacy Assessment： ripasudil-treated patients will be assessed in comparison to the medical records of a historical control group |
| Secondary | Proportion of patients with ROP remission in both eyes | week12 of treatment | Efficacy Assessment： ripasudil-treated patients will be assessed in comparison to the medical records of a historical control group |
| Secondary | Concentration of ripasudil and its metabolite M1 | throughout the study duration(up to week12) | Pharmacokinetics, the population pharmacokinetic(popPK) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04621136
GET https://conductscience.org/api/trials/v1/NCT04621136/registered