NCT01093170撤回1 期
A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy
Mark Kleinman1 个研究点 分布在 1 个国家开始时间: 2011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
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Safety and tolerability of RNA-144101 as measured by vision testing, ophthalmic and physical exams, vital signs, clinical laboratory testing and AEs.
研究概览
简要总结
This is a non-randomized, open-label, dose-escalating Phase Ia study performed at a single center designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of intravitreous administration of RNA-144101 in patients with geographic atrophy (GA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females of all races and ethnicities between the ages of 50-99
- •Female subjects must be 1-year postmenopausal or surgically sterilized and must have negative serum pregnancy test
- •Subjects must have GA from AMD in one or both eyes:
- •The study eye will be the eye that meets all inclusion/exclusion criteria
- •If both eyes meet criteria, then the eye with the smaller GA lesion will be studied
- •If the GA lesions are equal in size, then the eye with the best-corrected visual acuity (BCVA) will chosen as the study eye
- •If both eyes have the same lesion size and same BCVA, the right eye will be chosen
- •Subjects must have the following GA criteria for inclusion:
- •GA lesions with an area > 2.5mm2 and ≤ 20mm2 as determine by fluorescein angiography and fundus autofluorescence
- •A clear view to the fundus must be present in order to easily examine the study eye at baseline
- •BCVA In the study eye between 20/20 and 20/100 as measured on Snellen chart or 85-50 letters by ETDRS
- •Willing and able to provide signed informed consent prior to any study participation
排除标准
- •GA due to a disease other than AMD
- •Pregnancy or lactation
- •Treatment of any systemic infection
- •Autofluorescence pattern marked at none, focal or patchy
- •Ocular surgery in the study eye in the previous 6 months.
- •Presence or history of choroidal neovascularization (wet AMD) in the study eye
- •Any inflammatory (autoimmune, uveitis) or neovascular (diabetic retinopathy) disease of the retina
- •Any history of glaucoma or disc cupping in the study eye
- •Any history of severe dry eye disease
- •High myopia > - 8D or high hyperopia > +8D in the study eye
- •Presence of life-threatening disease
- •Abnormal basal metabolic panel or liver function tests
- •Current alcohol or other substance abuse
- •Unwilling or unable to provide signed informed consent for any study procedures
研究组 & 干预措施
RNA-144101
Experimental
干预措施: RNA-144101 (Drug)
结局指标
主要结局
Safety and tolerability of RNA-144101 as measured by vision testing, ophthalmic and physical exams, vital signs, clinical laboratory testing and AEs.
时间窗: Through study completion or discontinuation
次要结局
- Measurement of total aggregate area of GA lesions (as determined by color fundus photography and autofluorescence imaging)(Through duration of study or discontinuation)
- Pharmacokinetic studies measuring drug concentrations in serum over study period.(Through study completion or discontinuation)
研究者
Mark Kleinman
Sponsor/PI
University of Kentucky
研究点 (1)
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