NCT02125266终止1 期
A Prospective, Multi-Center, Randomized, Controlled Clinical Trial Designed to Evaluate the Safety and Preliminary Efficacy of V404 PDS in Chronic Noninfectious Uveitis
Forsight Vision40 个研究点目标入组 7 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 主要终点
- Frequency of adverse events
研究概览
简要总结
This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •18 years of age or older
- •Confirmed diagnosis of active uveitis
- •Sufficient lens/media clarity
- •Meet best-corrected visual acuity criteria
- •Willing and able to use contraception
排除标准
- •Pregnant, breast feeding
- •Uncontrolled glaucoma
- •Intraocular surgery or periocular/intraocular injections within 6 weeks
- •Periocular or intraocular steroid within 3 months
- •Prior vitrectomy
- •Prior corneal transplant
- •Prior fluocinolone implant
- •Allergy or sensitivity to study drug
- •Participation in other trial within 30 days
- •Abnormal liver function
- •History of positive serum tuberculosis test
研究组 & 干预措施
Low Dose V404 PDS
Experimental
Sustained intravitreal delivery of methotrexate (0.6 mg)
干预措施: V404 (Drug)
High Dose V404 PDS
Experimental
Sustained intravitreal delivery of methotrexate (2.3 mg)
干预措施: V404 (Drug)
结局指标
主要结局
Frequency of adverse events
时间窗: 6 months
次要结局
- Change in vitreous haze score(Baseline, 6 Months)
研究者
相似试验
已完成
1 期
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy SubjectsCognitive DisordersNCT02575482Suven Life Sciences Limited64
已完成
1 期
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy SubjectsViral InfectionNCT02061358Emergent BioSolutions64
Unknown
4 期
Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune DiseaseChronic Hepatitis CNCT02691728Peter J. Ruane, M.D., Inc.40
进行中（未招募）
3 期
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWSPrader-Willi SyndromeNCT06144645Foundation for Prader-Willi Research102
已完成
4 期
Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBVHepatitis BNCT00501124Bukwang Pharmaceutical70