JPRN-UMIN000034081已完成1 期
An investigator-initiated phase I/IIa trial of subretinal injection of DVC1-0401 as neuroprotective gene therapy for retinitis pigmentosa - An investigator-initiated trial of DVC1-0401 as gene therapy for retinitis pigmentosa
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) HIV antibody-positive 2) Decimal visual acuities of both eyes are less than 0.1, or lateral or bilateral blindness 3) Cone-rod dystrophy 4) Interocular difference in the condition of lens 5) Co-existence of glaucoma or ocular hypertension (intraocular pressure is more than or equal to 22 mmHg) 6) Co-existence of uveitis or optic neuritis 7) Retinal or subretinal pathological change observed by fundus examination (including fluorescein fundus angiography, laser scanning fundus photography), that is independent of retinitis pigmentosa 8) Visual field measured by Goldmann perimeter V-4e is less than 10 degree at the center area of vision 9) Loss or massive structural irregularity of the layer of retinal pigment epithelium on OCT (optical coherence tomography) at the supposed site of administration 10) Having severe allergy or previous history 11) Receiving chronic hemodialysis therapy 12) Severe heart dysfunction or heart failure 13) Sever hepatic dysfunction or liver cirrhosis 14) Active inflammatory diseases 15) History of cerebral hemorrhage or infarction within 6 months before agreement 16) Hematopoietic disorders 17) Alcoholism and/or drug dependence 18) Female subjects with pregnant or doubt of pregnancy. Breast-feeding female. 19) Subjects who are diagnosed with cancer or suspected to have cancer. History of treatment of malignancies within 5 years. 20) Disapprove of birth control during at least 12 months after the administration 21) Administration of Helenien, Unoprostone, and/or Ca antagonist intended for treatment of eye disease within 30 days before agreement 22) Taking the antiviral drug at the registration 23) Plan of operation other than administration of the investigational drug during this clinical trial 24) Entry into other clinical trial and/or clinical study, or history of entry within 6 months before agreement 25) Others: Subjects who are judged to be inappropriate by principal investigator or subinvestigator
研究者
相似试验
进行中（未招募）
1 期
An investigator-initiated trial of DVC1-0401 as gene therapy for retinitis pigmentosaRetinitis pigmentosaD012174RPJPRN-jRCT2073180024Ikeda Yasuhiro12
进行中（未招募）
1 期
Study of safety and efficacy of genome-edited hematopoietic stem and progenitor cells in sickle cell disease (SCD)EUCTR2019-003489-41-ITOVARTIS PHARMA AG30
进行中（未招募）
1 期
Study of the efficacy and safety of the Bintrafusp alfa (M7824) in previously treated cancer called malignant pleural mesothelioma.EUCTR2020-004902-67-ESFundación GECP47
进行中（未招募）
1 期
Individualized peptide vaccination trial in pediatric, adolecent and young adult patients with metastasized fusion-driven sarcomas following standard treatmentEUCTR2022-002793-91-DEniversity Hospital Tuebingen23
已完成
2 期
An early phase II trial for efficacy and safety of TTA-121 on autism spectrum disorderAutism spectrum disorderJPRN-UMIN000031412Hamamatsu University School of Medicine, Department of Psychiatry144