NCT03669393已完成2 期
A Phase 2, Open-label, Multi-centre Study to Assess the Efficacy and Safety of Intravitreal THR-317 for the Treatment of Macular Telangiectasia Type 1 (MacTel 1)
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
- 8
- 试验地点
- 3
- 主要终点
- Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)
研究概览
简要总结
This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1).
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 aged 18 years or older
- •Macular oedema caused by MacTel 1, with CST >300µm on SD-OCT
- •Written informed consent obtained from the subject prior to screening procedures
排除标准
- •Type 1 or type 2 Diabetes Mellitus
- •Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results
- •Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
- •Any active ocular / intraocular infection or inflammation in either eye
- •Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
研究组 & 干预措施
THR-317
Experimental
干预措施: THR-317 8mg (Drug)
结局指标
主要结局
Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)
时间窗: At Day 84 (Month 3)
次要结局
- Change from baseline in CST, based on SD-OCT, by study visit(From baseline to Day 140)
- Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit(From baseline to Day 140)
- Change from baseline in best-corrected visual acuity (BCVA), by study visit(From Day 0 to Day 140)
- Incidence of systemic and ocular adverse events including serious adverse events(From Day 0 to Day 140)
研究者
研究点 (3)
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