Retinitis Pigmentosa (RP)Phase 1RP CLARITINCT07774975
Safety Evaluation Study of Pitavastatin PLGA Nano-particle for Retinitis Pigmentosa
A Phase 1 study testing ULREA-PVS-NP in people with Retinitis Pigmentosa (RP), run by Kyushu University at 1 site in Japan.
Trial summary
Retinitis pigmentosa (RP) is a rare inherited retinal degenerative disease that causes progressive visual field loss and vision impairment, often leading to blindness. Currently, there are limited treatment options capable of slowing disease progression for the majority of patients with RP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Retinitis Pigmentosa (RP)
- What is being tested?
- ULREA-PVS-NP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2026to 31 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with typical retinitis pigmentosa by two ophthalmologists according to the Clinical Practice Guidelines for Retinitis Pigmentosa (genomic diagnosis will not be performed).
- Patients aged 18 years or older and 70 years or younger at the time of informed consent.
- * Patients with a mean retinal sensitivity of 10 dB or higher within the central 4 degrees (12 points) of the Humphrey 10-2 visual field.
- * Patients whose difference in mean retinal sensitivity (MD value) between two Humphrey 10-2 examinations at screening is within 3 dB. If the criteria are not met in the second examination, a third measurement will be performed within 14 days of the second examination, and the difference between the third measurement and the first or second measurement must be within 3 dB.
- * Patients with a foveal retinal thickness of 250 micrometer or less as measured by optical coherence tomography.
- At least one eye must meet criteria 3, 4, and 5.
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- Female patients of childbearing potential who agree to use appropriate contraception from the time of informed consent until 180 days after the last dose of the investigational product.
- Male patients who agree to use appropriate contraception for 3 days from each administration of the investigational product.
- Patients who can provide written informed consent.
Who cannot join
- Patients currently taking statins for hyperlipidemia.
- Patients who have received helenien, unoprostone, or calcium channel blockers for the treatment of eye diseases within 30 days prior to informed consent.
- Patients scheduled for ophthalmic surgery during the study period.
- Patients with concomitant glaucoma or ocular hypertension.
- Patients with concomitant uveitis or optic neuritis.
- Patients with retinal lesions not attributable to retinitis pigmentosa (e.g., fundus hemorrhage, retinal edema, proliferative tissue, etc.) observed on fundus examination.
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- Patients with a history of hypersensitivity or severe adverse reactions to pitavastatin calcium or any component of the investigational product.
- Patients with severe allergies or a history thereof.
- Patients with severe renal impairment.
- Patients with severe cardiac dysfunction or heart failure.
- Patients with severe hepatic impairment.
- Patients with biliary obstruction.
- Patients with active inflammatory diseases or infections (e.g., active collagen disease, rheumatoid arthritis, ulcerative colitis, sepsis, etc.).
- Patients with a history of cerebral hemorrhage, cerebral infarction, or ischemic heart disease within 6 months prior to informed consent.
- Patients with hematological disorders (e.g., severe anemia, leukemia, aplastic anemia, etc.).
- Patients with alcohol dependence, drug dependence, or mental disorders that may interfere with study participation.
- Patients with concomitant malignant tumors or who have received treatment for malignant tumors within the past 3 years.
- Patients currently receiving cyclosporine.
- Patients currently receiving fibrate drugs (e.g., clofibrate, fenofibrate, bezafibrate, etc.) who cannot discontinue fibrate drugs from 3 days prior to the start of investigational product administration.
- Patients currently receiving nicotinic acid, erythromycin, or rifampicin who cannot discontinue these drugs from 3 days prior to the start of investigational product administration.
- Patients currently participating in other clinical trials or studies.
- Pregnant women, women suspected of being pregnant, or lactating women.
- Any other patient judged unsuitable by the principal investigator or sub-investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Kyushu University Hospital
Fukuoka
Yusuke Murakami, +81-92-642-5648, murakami.yusuke.407@m.kyushu-u.ac.jp
About this study
Official title: Investigator-initiated Phase 1 Clinical Trial to Evaluate the Safety of Pitavastatin PLGA Nano-particle in Patients With Retinitis Pigmentosa
Retinitis pigmentosa (RP) is a rare inherited retinal degenerative disease that causes progressive visual field loss and vision impairment, often leading to blindness. Currently, there are limited treatment options capable of slowing disease progression for the majority of patients with RP. Preclinical studies have suggested that retinal inflammation, particularly the activity of inflammatory monocytes and macrophages, may contribute to photoreceptor degeneration. ULREA-PVS-NP is a novel intravenous formulation consisting of pitavastatin encapsulated in poly(lactic-co-glycolic acid) (PLGA) nanoparticles, developed to target inflammatory pathways associated with retinal degeneration. Preclinical studies demonstrated suppression of inflammatory monocyte/macrophage activity and preservation of photoreceptors in animal models of RP.
This is a single-center, open-label, investigator-initiated Phase 1 study designed to evaluate the safety of intravenous ULREA-PVS-NP in adults with RP. The study consists of two parts. In Part 1, participants will receive a single intravenous infusion of ULREA-PVS-NP at escalating dose levels (2 mg, 4 mg, or 8 mg) to evaluate safety and tolerability. Following review of safety data, Part 2 will evaluate repeated administration of the highest dose considered safe in Part 1, given once every four weeks for a total of three administrations.
The primary objective is to evaluate the safety of ULREA-PVS-NP by assessing the incidence of adverse events. Secondary objectives include characterization of pharmacokinetic profiles, evaluation of changes in clinical laboratory tests and vital signs, and exploratory assessment of ophthalmologic outcomes and inflammatory biomarkers.
- Conditions
- Retinitis Pigmentosa (RP)
- Being tested
- ULREA-PVS-NP
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULREA-PVS-NPDrug
ULREA-PVS-NP is a poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulation containing pitavastatin and administered intravenously. Part 1 is a single ascending-dose study in which participants receive a single intravenous administration of ULREA-PVS-NP at dose levels equivalent to 2 mg, 4 mg, or 8 mg of pitavastatin. Part 2 is a multiple-dose study in which participants receive repeated intravenous administrations at the highest dose level shown to be safe in Part 1.
| Study group | Role | What they receive |
|---|---|---|
| ULREA-PVS-NP | Experimental | Not described Receives: Drug: ULREA-PVS-NP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Part1: 28 days, Part2: 84 days
Secondary outcomes (14)
Time course of drug concentrations of pitavastatin and pitavastatin lactone in plasma.
Measured: 47 hours after the end of administration of the investigational drug
Urinary excretion of pitavastatin, pitavastatin lactone, and pitavastatin conjugates in urine.
Measured: 24 hours after the start of administration of the investigational drug
Changes from baseline (pre-investigational product administration) in body temperature.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (pre-investigational product administration) in blood pressure.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (pre-investigational product administration) in pulse rate.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (pre-investigational product administration) in transcutaneous arterial oxygen saturation.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in ETDRS visual acuity letter score.
Assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity letter score. Scores range from 0 to 100 letters, with higher scores indicating better visual acuity.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in OCT Ellipsoid Zone length.
Ellipsoid zone length will be assessed by optical coherence tomography (OCT). The outcome measure is the change in ellipsoid zone length from baseline (screening) at each scheduled assessment time point. A longer ellipsoid zone length is generally considered to reflect better preservation of photoreceptor structure.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in autofluorescence examination / fluorescent ring area.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in Humphrey 10-2 visual field analyzer / central 4-point mean sensitivity.
Visual field sensitivity will be assessed using the Humphrey Field Analyzer 10-2 program. The outcome measure is the change from baseline (screening) in the mean sensitivity of the central 4 test points, expressed in decibels (dB), at each scheduled assessment time point. Higher values indicate greater visual field sensitivity and better visual function.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in Humphrey 10-2 visual field analyzer / central 12-point mean sensitivity
Visual field sensitivity will be assessed using the Humphrey Field Analyzer 10-2 program. The outcome measure is the change from baseline (screening) in the mean sensitivity of the central 12 test points, expressed in decibels (dB), at each scheduled assessment time point. Higher values indicate greater visual field sensitivity and better visual function.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in Humphrey 10-2 visual field analyzer / MD value.
Visual field sensitivity will be assessed using the Humphrey Field Analyzer 10-2 program. The outcome measure is the change from baseline (screening) in mean deviation (MD), expressed in decibels (dB), at each scheduled assessment time point. Mean deviation represents the average difference in visual field sensitivity compared with age-matched normal values. Higher (less negative) MD values indicate better visual field function.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in Humphrey 10-2 visual field analyzer / functional transition points (FTP) retinal sensitivity
Visual field sensitivity will be assessed using the Humphrey Field Analyzer 10-2 program. Functional transition points (FTPs) are predefined at baseline as retinal test locations demonstrating a sensitivity gradient of at least 7 dB between adjacent points from the central visual field. FTP retinal sensitivity is calculated as the mean retinal sensitivity (dB) of qualifying FTP locations according to the prespecified algorithm. The outcome measure is the change from baseline (screening) in FTP retinal sensitivity at each scheduled assessment time point. Higher values indicate better retinal sensitivity.
Measured: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in anterior chamber flare value.
Anterior chamber flare will be assessed by laser flare photometry. The outcome measure is the change from baseline (screening) in anterior chamber flare value at each scheduled assessment time point. Anterior chamber flare reflects the level of protein leakage into the aqueous humor and is an indicator of intraocular inflammation and blood-aqueous barrier disruption. Lower values generally indicate less intraocular inflammation.
Measured: Part1: 28 days, Part2: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startOct 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis Pigmentosa (RP)Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyushu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuke Murakami, Kyushu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774975
- Sponsor's protocol ID
- CTR192-01
- Other IDs
- JP25lk0221213
- Acronym
- RP CLARITI
- Status last verified
- Oct 2026
- First submitted
- 15 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated Phase 1 Clinical Trial to Evaluate the Safety of Pitavastatin PLGA Nano-particle in Patients With Retinitis Pigmentosa
- ClinicalTrials.gov ID
- NCT07774975
- Acronym / sponsor ID
- RP CLARITI / CTR192-01
- Conditions
- Retinitis Pigmentosa (RP)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Kyushu UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 19 Aug 2026 (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.
Retinitis pigmentosa (RP) is a rare inherited retinal degenerative disease that causes progressive visual field loss and vision impairment, often leading to blindness. Currently, there are limited treatment options capable of slowing disease progression for the majority of patients with RP. Preclinical studies have suggested that retinal inflammation, particularly the activity of inflammatory monocytes and macrophages, may contribute to photoreceptor degeneration. ULREA-PVS-NP is a novel intravenous formulation consisting of pitavastatin encapsulated in poly(lactic-co-glycolic acid) (PLGA) nanoparticles, developed to target inflammatory pathways associated with retinal degeneration. Preclinical studies demonstrated suppression of inflammatory monocyte/macrophage activity and preservation of photoreceptors in animal models of RP.
This is a single-center, open-label, investigator-initiated Phase 1 study designed to evaluate the safety of intravenous ULREA-PVS-NP in adults with RP. The study consists of two parts. In Part 1, participants will receive a single intravenous infusion of ULREA-PVS-NP at escalating dose levels (2 mg, 4 mg, or 8 mg) to evaluate safety and tolerability. Following review of safety data, Part 2 will evaluate repeated administration of the highest dose considered safe in Part 1, given once every four weeks for a total of three administrations.
The primary objective is to evaluate the safety of ULREA-PVS-NP by assessing the incidence of adverse events. Secondary objectives include characterization of pharmacokinetic profiles, evaluation of changes in clinical laboratory tests and vital signs, and exploratory assessment of ophthalmologic outcomes and inflammatory biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ULREA-PVS-NP | Experimental | Drug: ULREA-PVS-NP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients diagnosed with typical retinitis pigmentosa by two ophthalmologists according to the Clinical Practice Guidelines for Retinitis Pigmentosa (genomic diagnosis will not be performed).
- Patients aged 18 years or older and 70 years or younger at the time of informed consent.
- * Patients with a mean retinal sensitivity of 10 dB or higher within the central 4 degrees (12 points) of the Humphrey 10-2 visual field.
- * Patients whose difference in mean retinal sensitivity (MD value) between two Humphrey 10-2 examinations at screening is within 3 dB. If the criteria are not met in the second examination, a third measurement will be performed within 14 days of the second examination, and the difference between the third measurement and the first or second measurement must be within 3 dB.
- * Patients with a foveal retinal thickness of 250 micrometer or less as measured by optical coherence tomography.
Key exclusion criteria (23 listed)
- Patients currently taking statins for hyperlipidemia.
- Patients who have received helenien, unoprostone, or calcium channel blockers for the treatment of eye diseases within 30 days prior to informed consent.
- Patients scheduled for ophthalmic surgery during the study period.
- Patients with concomitant glaucoma or ocular hypertension.
- Patients with concomitant uveitis or optic neuritis.
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 |
|---|---|---|
| ULREA-PVS-NPULREA-PVS-NP is a poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulation containing pitavastatin and administered intravenously. Part 1 is a single ascending-dose study in which participants receive a single intravenous administration of ULREA-PVS-NP at dose levels equivalent to 2 mg, 4 mg, or 8 mg of pitavastatin. Part 2 is a multiple-dose study in which participants receive repeated intravenous administrations at the highest dose level shown to be safe in Part 1. | Drug | ULREA-PVS-NP |
Primary outcome
Incidence of adverse events
Time frame: Part1: 28 days, Part2: 84 days
14 secondary outcomes
Time course of drug concentrations of pitavastatin and pitavastatin lactone in plasma.
Time frame: 47 hours after the end of administration of the investigational drug
Urinary excretion of pitavastatin, pitavastatin lactone, and pitavastatin conjugates in urine.
Time frame: 24 hours after the start of administration of the investigational drug
Changes from baseline (pre-investigational product administration) in body temperature.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (pre-investigational product administration) in blood pressure.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (pre-investigational product administration) in pulse rate.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (pre-investigational product administration) in transcutaneous arterial oxygen saturation.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in ETDRS visual acuity letter score.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in OCT Ellipsoid Zone length.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in autofluorescence examination / fluorescent ring area.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in Humphrey 10-2 visual field analyzer / central 4-point mean sensitivity.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in Humphrey 10-2 visual field analyzer / central 12-point mean sensitivity
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in Humphrey 10-2 visual field analyzer / MD value.
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in Humphrey 10-2 visual field analyzer / functional transition points (FTP) retinal sensitivity
Time frame: Part1: 28 days, Part2: 84 days
Changes from baseline (at screening) in anterior chamber flare value.
Time frame: Part1: 28 days, Part2: 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ULREA-PVS-NP in people with Retinitis Pigmentosa (RP), run by Kyushu University at 1 site 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 9 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusuke Murakami, MD, PhD (+81926425648, murakami.yusuke.407@m.kyushu-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Part1: 28 days, Part2: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.