jRCT2071260006尚未招募不适用
Investigator-initiated Phase 1 clinical trial to evaluate the safety of Pitavastatin PLGA nano-particle in patients with retinitis pigmentosa (Phase 1 clinical trial to evaluate the safety of Pitavastatin PLGA nano-particle in patients with retinitis pigmentosa)
未提供0 个研究点目标入组 21 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 70age old under（—）
- 性别
- All
入选标准
- •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 for both eyes. 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.
- •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.
排除标准
- •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.
- •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.
研究者
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