A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of MT-0814 for the Treatment of Patients With Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Best-corrected Visual Acuity (BCVA) : Study Eye
研究概览
简要总结
Age-related macular degeneration (AMD) is the leading cause of blindness among adults in North America. The current standard of care for patients with exudative ("wet") AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy which must be administered by an injection into the eye every 4-8 weeks. MT-0814 is being developed for the treatment of patients with exudative AMD, and could offer an alternative, safer and less burdensome therapy.
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
- •Must agree to sign informed consent form, and to comply with protocol requirements, including study visits.
- •Must have clear optic media in the study eye that is capable of producing high-quality fundus images.
排除标准
- •Has active CNV due to causes other than AMD in the study eye.
- •Has retinal vascular disease or retinal degeneration other than AMD in the study eye.
- •Has had intraocular surgery, cataract surgery or LASIK surgery on the study eye within 90 days prior to the study.
- •Has had yttrium aluminum garnet (YAG) laser capsulotomy on the study eye within 30 days prior to the study.
- •Has active inflammation, infection, or other severe ocular disease in either eye.
- •Has aphakia in the study eye.
- •Has uncontrolled glaucoma or a history of previous glaucoma filter surgery in either eye.
- •Is a contact lens wearer and is unable to discontinue their use in both eyes for the duration of the study.
- •Has a serious allergy to, or experienced a prior significant adverse reaction to fluorescein angiography (FA) or indocyanine green angiography (ICGA).
- •Has participated in any other clinical trial and/or has taken any investigational drug or product within 90 days prior to the study.
- •Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
MT-0814 Low dose
MT-0814 plus placebo
干预措施: MT-0814 (Drug)
MT-0814 Low dose
MT-0814 plus placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Placebo (Drug)
MT-0814 High dose
干预措施: MT-0814 (Drug)
结局指标
主要结局
Change in Best-corrected Visual Acuity (BCVA) : Study Eye
时间窗: Baseline and Week 12
Change from Baseline in BCVA. BCVA was measured using an eye chart and is reported as number of letters read correctly using Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (0 to 100 letters) in study eye. Lower number of letters read correctly, worse the vision. Study eye: eye that meets inclusion criteria. If both eyes meet all inclusion and exclusion criteria, the eye with the lower BCVA at Screening will be selected as the study eye. If both eyes meet all inclusion criteria and have identical BCVA at Screening, selection of the study eye will be at the investigator's discretion.
次要结局
- Change in Central Subfield Thickness (CSFT) : Study Eye(Baseline and Week 12)