NCT00259753已完成2 期
A Phase II, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration
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
- 120
- 试验地点
- 23
- 主要终点
- change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
研究概览
简要总结
The objective of this study is to evaluate the safety and preliminary efficacy of three doses of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
- •Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
- •Patients must be age 50 or older
排除标准
- •Patients who have received prior treatment with any investigational new drug or device for wet AMD in the study eye within 24 weeks of the screening visit.
- •Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
- •Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
- •Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
- •Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
- •Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
- •Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.
研究组 & 干预措施
1
Experimental
0.2 mg/eye
干预措施: Bevasiranib (Drug)
2
Experimental
1.5 mg/eye
干预措施: Bevasiranib (Drug)
3
Experimental
3.0 mg/eye
干预措施: Bevasiranib (Drug)
结局指标
主要结局
change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
时间窗: 12 week
次要结局
- The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.(12 week)
研究者
研究点 (23)
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