NCT04812067已完成2 期
A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Specular Microscopy
研究概览
简要总结
Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older
- •Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
- •Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
- •Fellow Eye with 20/100 BCVA or better
- •No concurrent ocular or medical condition that would impair the assessment of safety and efficacy
排除标准
- •Prior exposure to TTHX1114
- •Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
- •Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
- •History of:
- •Ocular cancer (including melanoma)
- •Herpetic keratitis
- •Documented and repeated elevated IOP in either eye
- •Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy)
- •Use of any concomitant medications that may interfere with the assessment of safety and efficacy
- •Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study
研究组 & 干预措施
TTHX1114 weekly x 5
Experimental
TTHX1114 via IC injection weekly x 5
干预措施: TTHX1114 (Drug)
结局指标
主要结局
Specular Microscopy
时间窗: Day 28
Corneal Endothelial Cell Density
次要结局
- Pachymetry(Day 28)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X AlleleCystic FibrosisNCT04135495Eloxx Pharmaceuticals, Inc.17
招募中
1 期
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid TumorsAdvanced Solid TumorsGenital Neoplasm, FemaleUrogenital NeoplasmsNeoplasms by SitePapillomavirus InfectionEpstein-Barr Virus InfectionsCarcinomaNeoplasmsVulvar NeoplasmsVulvar DiseasesAbdominal NeoplasmLung NeoplasmNSCLC (Non-small Cell Lung Cancer)Colorectal CancerNCT05592626Marengo Therapeutics, Inc.366
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's DiseaseParkinson's DiseaseNCT02224664Pfizer50
撤回
1 期
Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMSSecondary Progressive Multiple Sclerosis (SPMS)NCT03696485Stem Cell Medicine Ltd.
已完成
1 期
An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid TumorsNon-small Cell Lung Cancer (NSCLC)Head and Neck Squamous Cell Carcinoma (HNSCC)Hepatocellular Carcinoma (HCC)NCT03735628Bayer16