TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 19
- 主要终点
- Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye
研究概览
简要总结
Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.
详细描述
Part 1 is a randomized, double-maskedtrial trial designed to investigate the use of TLC399 in subjects with macular edema due to CRVO or BRVO. Three different dose strengths will be evaluated.
Part 2 is a randomized, double-masked study designed to evaluate 2 doses of TLC399 in subjects with macular edema due to CRVO or BRVO. Subjects will be randomized 1:1 to receive two different dose strenghs of investigational product.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •male or female, at least 18 years of age
- •macular edema due to CRVO or BRVO
- •best-corrected visual acuity (BCVA) score of 20/40 to 20/400
- •mean central subfield thickness (CST) ≥350 um
- •willing and able to comply with the study procedure and sign a written informed consent
- •agree to use a medically acceptable form of birth control
排除标准
- •poorly controlled diabetes
- •history of significant intraocular pressure (IOP) elevation to steroid treatment
- •history of ocular hypertension and glaucoma
- •cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening
- •use of hemodilution for the treatment of RVO
- •use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to screening; or IVT aflibercept within 8 weeks prior to screening
- •IVT Ozurdex to the study eye within 6 months prior to screening
- •prior use of Retisert or Iluvien
- •use of systemic steroids or heparin within 1 month prior to screening
研究组 & 干预措施
Group 1
TLC399 (ProDex) 0.36mg DSP with 100 mM PL
干预措施: TLC399 (ProDex) (Drug)
Group 2
TLC399 (ProDex) 0.6 mg DSP with 100 mM PL
干预措施: TLC399 (ProDex) (Drug)
Group 3
TLC399 (ProDex) 0.6 mg DSP with 50 mM PL
干预措施: TLC399 (ProDex) (Drug)
Group 4
TLC399 (ProDex) 0.84 mg DSP with 50 mM PL
干预措施: TLC399 (ProDex) (Drug)
结局指标
主要结局
Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye
时间窗: 6 months after dosing
Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye. Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters.
次要结局
未报告次要终点