NCT00722384已完成1 期
An Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5 by Single Intravitreal Injection in Patients With Wet Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Complications, including those related to the intravitreal injection, and adverse events, and loss of lines of best-corrected visual acuity, slit lamp findings, lens opacification, intraocular pressure, fundus findings, and laboratory findings.
研究概览
简要总结
To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with subfoveal predominantly classic, minimally classic and purely occult lesions, secondary to age related macular degeneration, with a total lesion size (including blood, atrophy/scar and neovascularization) of < 12 total disc areas, of which at least 50% are active CNV.
- •Patients must have visual acuity 20/50 to 20/320 in the study eye.
- •Patients must have better visual acuity in the fellow eye than the study eye.
- •Subretinal hemorrhage (if any) must comprise no more than 50% of total lesion size.
排除标准
- •Patients with concomitant eye disease, including glaucoma, uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection in the study eye.
- •Patients with > 3 prior PDT treatments with Visudyne in the study eye.
- •Patients who received PDT in the study eye within eight weeks prior to the baseline angiography/photography.
研究组 & 干预措施
1
Experimental
0.1 mg bevasiranib in the study eye
干预措施: bevasiranib (Drug)
2
Experimental
0.33 mg bevasiranib in the study eye,
干预措施: bevasiranib (Drug)
3
Experimental
1.0 mg bevasiranib in the study eye
干预措施: bevasiranib (Drug)
4
Experimental
1.5 mg bevasiranib in the study eye
干预措施: bevasiranib (Drug)
5
Experimental
3.0 mg bevasiranib in the study eye.
干预措施: bevasiranib (Drug)
结局指标
主要结局
Complications, including those related to the intravitreal injection, and adverse events, and loss of lines of best-corrected visual acuity, slit lamp findings, lens opacification, intraocular pressure, fundus findings, and laboratory findings.
次要结局
- Stabilization of visual acuity (prevention of loss of three or more lines on the ETDRS chart), stabilization of lesion size, lack of leakage of lesion, or decrease in subretinal fluid
研究者
研究点 (1)
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