NCT05026632进行中（未招募）1 期
Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lens Densitometry
研究概览
简要总结
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Indicated for vitrectomy
- •Natural Lens in place at time of vitrectomy
- •Some cataract present as assessed pre-operatively
排除标准
- •Previous intraocular surgery in study eye.
- •Clear zonular weakness or defects / coloboma.
- •Not on stable dose of medications for other conditions.
- •Need for oral corticosteroids during study participation.
- •Evidence or history of uveitis, or ocular ischemia.
- •Current smoker
- •Use of supplemental oxygen
- •Evidence or history of proliferative diabetic retinopathy.
- •Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation.
- •Sensitivity to thiol compounds.
- •Participation in another clinical trial.
研究组 & 干预措施
Control
No Intervention
No implant inserted at time of vitrectomy
Double NPI-002 Intravitreal Implant
Experimental
two NPI-002 implants inserted at the time of vitrectomy
干预措施: NPI-002 Intravitreal Implant (Drug)
Single NPI-002 Intravitreal Implant
Experimental
one NPI-002 implant inserted at the time of vitrectomy
干预措施: NPI-002 Intravitreal Implant (Drug)
结局指标
主要结局
Lens Densitometry
时间窗: 6 months
Change from Baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Efficacy and Safety of Bilateral Intravitreal Injection of GS010Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 geneMedDRA version: 20.1 Level: LLT Classification code 10062951 Term: Leber's hereditary optic atrophy neuropathy System Organ Class: 100000004850EUCTR2017-002187-40-GBGENSIGHT BIOLOGICS90
进行中（未招募）
1 期
Efficacy and Safety of Bilateral Intravitreal Injection of GS010Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 geneEUCTR2017-002187-40-NLGENSIGHT BIOLOGICS90
进行中（未招募）
1 期
Efficacy and Safety of Bilateral Intravitreal Injection of GS010eber Hereditary Optic Neuropathy due to mutations in the mitochondrialNADH Dehydrogenase 4 geneMedDRA version: 20.1Level: LLTClassification code 10062951Term: Leber's hereditary optic atrophy neuropathySystem Organ Class: 100000004850EUCTR2017-002187-40-FRGENSIGHT BIOLOGICS90
进行中（未招募）
1 期
Efficacy and Safety of Bilateral Intravitreal Injection of GS010Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 geneEUCTR2017-002187-40-BEGENSIGHT BIOLOGICS90
进行中（未招募）
1 期
Efficacy and Safety of Bilateral Intravitreal Injection of GS010eber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 geneMedDRA version: 20.1Level: LLTClassification code 10062951Term: Leber's hereditary optic atrophy neuropathySystem Organ Class: 100000004850EUCTR2017-002187-40-ITGENSIGHT BIOLOGICS90