NCT01786395终止3 期
Phase III Clinical Study of UF-021 for Retinitis Pigmentosa - Evaluation for a Comparative Double Masked Placebo Controlled Study Period and a Continuous Administration Period
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 202
- 主要终点
- Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2)
研究概览
简要总结
This study is a multicenter trial performed in Japan, consisting of a comparative study period and a continuous administration period.
Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study in patients with retinitis pigmentosa.
The safety of same eye drops will also be examined in 52 weeks continuous administration period, in all the patients who completed the comparative study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20 years or more, 70 years or less (at obtaining informed consent)
- •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 reliable measurements with HFA (10-2) (SITA-Standard) 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 within 31 days from the 2nd test. The difference between the 3rd reliable measurement value and the 1st or 2nd measurements must be less than 3 dB, and both values are worse than 30 dB; the most recent data will be regarded as the data acquired before instillation.)
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 Ⅱ trial (including subjects 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 (grade 3 of the Emery classification) 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
研究组 & 干预措施
- Placebo
Placebo Comparator
干预措施: Placebo (Drug)
- UF-021
Experimental
UF-021 is experimental code for isopropyl unoprostone
干预措施: UF-021 (Drug)
结局指标
主要结局
Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2)
时间窗: baseline and 1 year
次要结局
- - Changes in the value of the retinal sensitivity through HFA (10-2) (MD value, mean retinal sensitivity at 12 central points /24 central points /68 central points)(baseline and 1 year)
- - Changes in the value of retinal thickness through OCT(baseline and 1 year)
- - Changes in the value of the ETDRS visual acuity(baseline and 1 year)
- - Changes in the VFQ-25 (composite 8) value(baseline and 1 year)
- - Changes in the Goldmann visual field area within V4e isopter(baseline and 1 year)
研究者
相似试验
已完成
3 期
SVT-15652 Otic Solution for the Treatment of OtomycosisOtomycosisNCT03686384Salvat217
已完成
3 期
SVT-15652 Otic Solution for the Treatment of Otomycosis.OtomycosisNCT03686397Salvat194
已完成
3 期
ATALANTE: Atezolizumab vs Placebo Phase III Study in Late Relapse Ovarian Cancer Treated With Chemotherapy+BevacizumabOvarian CancerNCT02891824ARCAGY/ GINECO GROUP614
终止
3 期
Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.Conjunctivitis, BacterialNCT03696342Laboratorios Sophia S.A de C.V.46
已完成
3 期
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLCNon-Small Cell Lung CancerNCT02364999Pfizer719