NCT00745511Unknown1 期
A Randomized, Multi-Center, Double Blind, 3 Arm, Phase I/II Pilot Study to Evaluate the Safety and Efficacy of Treatment With ORA102 Combined With Avastin (Bevacizumab) Versus Avastin Alone, in Patients With Neovascular Age Related Macular Degeneration (AMD)
Ora Bio Ltd.5 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- The incidence and severity of ocular adverse events, including retinal detachment, increase in IOP, cataract, tearing of the retina, decrease in vision, RPE atrophy, and vitreous hemorrhage, will be evaluated.
研究概览
简要总结
This is s randomized, multi-center, double blind, 3 arm, phase I/II pilot study to evaluate the safety and efficacy of treatment with ORA102 combined with Avastin (Bevacizumab) versus Avastin alone, in patients with neo-vascular age related macular degeneration (AMD).
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
- •Subjects who have provided informed consent, including signing of the informed consent form
- •Subject who are able and willing to comply with the study protocol
- •Subject must have best corrected visual acuity ETDRS between 20/40 to 20/320 in the study eye
- •Subjects whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy
- •Women must be post-menopausal 1 year or surgically sterilized. If not, negative serum pregnancy test required within 14 days of randomization
排除标准
- •Pregnant or lactating women
- •Patients with severe myocardial disease or coronary occlusion
- •Patients with severe personality disorder, suicidal risk or psychosis
- •Patients with previous history of CVA
- •Evidence for liver dysfunction - bilirubin level more than twice than upper limit of the normal value OR ALT/AST>1.5x upper limit of normal value
- •Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of the investigational drugs or puts the patients in high risk for treatment related complications
研究组 & 干预措施
1
Active Comparator
干预措施: ORA102 and Avastin (Drug)
2
Active Comparator
干预措施: ORA102 and Avastin (Drug)
3
Placebo Comparator
干预措施: Avastin (Drug)
结局指标
主要结局
The incidence and severity of ocular adverse events, including retinal detachment, increase in IOP, cataract, tearing of the retina, decrease in vision, RPE atrophy, and vitreous hemorrhage, will be evaluated.
时间窗: 32 weeks
次要结局
- Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32(32 weeks)
研究者
研究点 (5)
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