A Phase I, Open-Label, Dose-Escalation Study to Investigate the Safety of ISTH0036, a 'Next Generation' TGF-β2-Selective Antisense Oligonucleotide, in Subjects With Primary Open-Angle Glaucoma Undergoing Trabeculectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)
研究概览
简要总结
This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2, to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery outcome by prevention of excessive scarring and trabecular meshwork transformation.
详细描述
The transforming growth factor beta (TGF-β) is known to play a key role in glaucoma. Increased levels of TGF-β2 in the eye have been linked to trabecular meshwork transformation, increased intraocular pressure and direct optic nerve damage.
Trabeculectomy is the standard surgical intervention to reduce intraocular pressure in subjects no longer sufficiently responding to pressure-lowering medications. Scarring of the surgically opened canal (bleb) often abolishes the effect of trabeculectomy (despite the intraoperative use of Mitomycin C to prevent this). TGF-β2 has been described to play a distinct role in the fibrotic process of bleb closure.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject scheduled for trabeculectomy with Mitomycin C
- •Subject no longer tolerating or benefitting from pharmacologic treatment of glaucoma
排除标准
- •History of relevant ocular trauma < 6 months or ocular infection/inflammation < 3 months
- •severe central visual field loss within 6 months unrelated to glaucoma
- •pregnant or nursing women or subjects not using adequate contraception
- •history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluations, procedures or interpretation
研究组 & 干预措施
TGF-β2 antisense oligonucleotide
Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses
Post-Study Follow-up: until 1 year after administration
干预措施: TGF-β2 antisense oligonucleotide (Drug)
TGF-β2 antisense oligonucleotide
Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses
Post-Study Follow-up: until 1 year after administration
干预措施: Trabeculectomy (Procedure)
结局指标
主要结局
Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)
时间窗: 1 year
次要结局
- Intraocular pressure(1 year)
- Number of interventions post trabeculectomy(1 year)
- Visual field(1 year)