Retinopathy of PrematurityPhase 1/2NCT04621136
PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
A Phase 1/2 study testing Ripasudil ophthalmic solution 0.4% in people with Retinopathy of Prematurity, run by Kyushu University at 3 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Ripasudil ophthalmic solution 0.4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesJapan
- Study dates
- 1 Nov 2020to 31 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Kyushu University Hospital
Fukuoka, 812-8582
University Hospital of Occupational and Environmental Health
Kitakyushu, Fukuoka, 807-8555
Yamaguchi University Hospital
Ube, Yamaguchi, 755-850
About this study
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).
Read the 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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Ripasudil ophthalmic solution 0.4%
- Keywords
- Retinopathy of Prematurity, ROP
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripasudil ophthalmic solution 0.4%Drug
Also called GLANATEC 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.
| Study group | Role | What they receive |
|---|---|---|
| Ripasudil eye drops | Experimental | Ripasudil eye drops Receives: Drug: Ripasudil ophthalmic solution 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs)
Safety Assessment
Measured: throughout the study duration(up to week16)
Secondary outcomes (3)
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
Measured: week12 of treatment
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
Measured: week12 of treatment
Concentration of ripasudil and its metabolite M1
Pharmacokinetics, the population pharmacokinetic(popPK)
Measured: throughout the study duration(up to week12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Nov 2020
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyushu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitsuru Arima, Kyushu University
- Investigators
- Mitsuru Arima, MD,PhD, Principal investigator, Kyushu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621136
- Sponsor's protocol ID
- CTR180-01
- Status last verified
- Feb 2023
- First submitted
- 4 Nov 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27124322Arima 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.
PubMed 34315793
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT04621136
- Acronym / sponsor ID
- CTR180-01
- Conditions
- Retinopathy of Prematurity
- Keywords
- Retinopathy of Prematurity, ROP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kyushu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ripasudil eye drops | Experimental | Drug: Ripasudil ophthalmic solution 0.4%Ripasudil eye drops |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ripasudil ophthalmic solution 0.4%Also: GLANATEC 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. | Drug | Ripasudil eye drops |
Primary outcome
Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs)
Time frame: throughout the study duration(up to week16)
Safety Assessment
3 secondary outcomes
Proportion of patients whose ROP worsens to Type1 ROP in one or both eyes
Time frame: week12 of treatment
Proportion of patients with ROP remission in both eyes
Time frame: week12 of treatment
Concentration of ripasudil and its metabolite M1
Time frame: throughout the study duration(up to week12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Background: PubMed 27124322Yamaguchi 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.
- Derived from this study: PubMed 34315793Arima 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.
- Individual participant dataSharing planned: No
Related trials for Retinopathy of Prematurity
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitsuru Arima, MD,PhD principal investigator
Kyushu University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ripasudil ophthalmic solution 0.4% in people with Retinopathy of Prematurity, run by Kyushu University at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs) (time frame: throughout the study duration(up to week16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621136, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.