A Phase 1 interventional study of ULREA-PVS-NP in Retinitis Pigmentosa (RP), sponsored by Kyushu University. Recruiting at 1 site in Japan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Kyushu University · Phase 1, Interventional, and Treatment
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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.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 21 is below the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Kyushu University is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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* 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ULREA-PVS-NP
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.
Incidence of adverse events
Time frame: Part1: 28 days, Part2: 84 days
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.
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.
Time frame: 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.
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.
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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Part1: 28 days, Part2: 84 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 7, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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