jRCT2080222033未知3 期
Phase 3 Clinical Study of UF-021 for Retinitis Pigmentosa - Evaluation for a Comparative Double Masked Placebo Controlled Study Period and a Continuous Administration Period
试验速览
- 阶段
- 3 期
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- The comparative study period is placebo-controlled, double-masked study. In the 52 weeks continuous administration period, all the patients are treated with UF-021 eye drops.
入排标准
- 年龄范围
- 20age old over 至 70age old under（—）
- 性别
- All
入选标准
- •Medical examination classification: Outpatients
- •Observation, examination, and surveillance in accordance with the study protocol are judged to be feasible.
- •ETDRS visual acuity test is judged to be feasible at a distance of 4 meters.
- •HFA (10-2) test is judged to be feasible by investigator.
- •Goldmann perimetry shows concentric central visual field loss (including a ring scotoma) with the central 30 degrees or less.
- •The difference in the mean retinal sensitivity at four central points must be less than 3 dB between two measurements with HFA (10-2) conducted within 31 days and both values are worse than 30 dB.
- •(When this criterion is not met after two tests, a 3rd measurement will be implemented.)
排除标准
- •Judged to have difficulty by investigator for visiting the hospital and returning home safely over the study period.
- •Planning to undergo an ophthalmic operation for eye for efficacy evaluation during study period.
- •Current treatment for glaucoma or ocular hypertension.
- •Prior ophthalmectomy or evisceration of an eye
- •Intraocular surgery within the past five months.
- •History of allergy to drugs (instillation narcotics, fluorescein, etc.) that will be used during the clinical study, and to drugs similar to the investigational product
- •Complications of diabetic retinopathy.
- •Complications of external eye inflammation, infectious diseases, or severe dry eye.
- •Use of isopropyl unoprostone in the past or present.
- •Use of the following drugs within 31 days before obtaining informed consent.
- •Calcium antagonists, Dark adaptation improvement drug (helenien)
- •Participation in UF-021 phase 2 trial (including subjectss assigned to the placebo group).
- •Participation in other clinical studies within the past 6 months (However, any subject who has not been administered an investigational product will be accepted)
- •Pregnancy or the possibility of becoming pregnant. Currently breastfeeding. Childbearing patients who wish to become pregnant during the clinical study period and are not using appropriate contraceptive measures.
- •Cone-rod dystrophy where cone function was primarily impaired
- •History of optic nerve disease in the eye for efficacy evaluation
- •Complications of a moderate or more severe central cataract, an anterior subcapsular cataract, a posterior subcapsular cataract, and posterior capsule opacification that may exert a major influence on visual acuity in the eye for efficacy evaluation
- •History of retinal detachment (including cases that have undergone surgery) or complications of retinal disease that may progress in the eye for efficacy evaluation
- •Complications of marked macular oedema (or a cyst), an epimacular membrane or macular traction on the optical coherence tomography (OCT) findings in the eye for efficacy evaluation
- •Severe renal disease (blood urea nitrogen: 25 mg/dL or more and/or serum creatinine: 1.5 mg/dL or more), hepatic disease (aspartate aminotransferase [glutamic-oxaloacetic transaminase]) and/or alanine aminotransferase [glutamic-pyruvic transaminase] is 100 U or more), diabetes mellitus with inadequate control, complications of unstable angina, or a history of myocardial infarction
结局指标
主要结局
-
- Efficacy : Retinal sensitivity - Safety
次要结局
未报告次要终点
研究者
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已完成
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