Safety Evaluation Study of Pitavastatin PLGA Nano-particle for Retinitis Pigmentosa

Prior treatment

• Patients currently taking statins for hyperlipidemia.
• 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 a history of cerebral hemorrhage, cerebral infarction, or ischemic heart disease within 6 months prior to informed consent.
• 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.

Other illness

• Patients with retinal lesions not attributable to retinitis pigmentosa (e.g., fundus hemorrhage, retinal edema, proliferative tissue, etc.) observed on fundus examination.
• 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 active inflammatory diseases or infections (e.g., active collagen disease, rheumatoid arthritis, ulcerative colitis, sepsis, etc.).
• 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.

Lab values

• Patients who have received helenien, unoprostone, or calcium channel blockers for the treatment of eye diseases within 30 days prior to informed consent.
• Patients with a history of hypersensitivity or severe adverse reactions to pitavastatin calcium or any component of the investigational product.

Other

• Patients with biliary obstruction.
• 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.

• 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.
• 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.