A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Pharmacokinetics and Bioactivity of a Single Intravitreal Injection of DE-120 Injectable Solution for the Treatment of Late Stage Exudative Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 10
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, bioactivity and pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in subjects with late stage exudative age-related macular degeneration.
详细描述
This is an open-label, dose-escalating, sequential-cohort study of DE-120 injectable solution administered in 9, and up to 12, subjects with late stage exudative age-related macular degeneration.
Three cohorts of 3 subjects will receive a single intravitreal injection in the study eye. Subjects in Cohort 1 will receive a single intravitreal injection of Low Dose DE-120 injectable solution in the study eye and will be evaluated through Visit 5 (Month 1). If the Low Dose is considered to be safe, the next higher dose will be administered to Cohort 2.
The same enrollment and safety review procedures will be followed for Cohort 2 (Medium Dose DE-120) and Cohort 3 (High Dose DE-120).
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and provide signed written informed consent
- •Diagnosis of chronic subretinal or intraretinal fluid secondary to exudative age-related macular degeneration in the study eye
- •At least one lesion in the study eye that meets minimal pathology criteria
- •Visual acuity of ≤ 55 ETDRS letter (20/80 Snellen equivalent) or worse in the study eye, excluding No Light Perception
- •Reasonably clear media and some fixation in the study eye
排除标准
- •Visual acuity of No Light Perception
- •Aphakic or has an anterior chamber intraocular lens in the study eye.
- •Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1
- •Uncontrolled glaucoma, chronic hypotony or vitrectomy in the study eye
- •Evidence of any other ocular disease other than late stage exudative age related macular degeneration in the study eye that may confound the outcome of the study .
- •Proscribed ocular surgery in the study eye either prior to or during the course of the trial
- •Presence or history of certain ocular or periocular pathology or conditions that could limit ability to perform required study assessments in either eye and/or confound study results
- •Systemic treatment with anti-VEGF agents (e.g., bevacizumab) is prohibited at any time during the study
- •Allergy or hypersensitivity to study drug product, fluorescein dye, or other study related procedures/medications.
- •Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for a clinical trial
- •Participation in other investigational drug or device clinical trials within 30 days prior to Screening or planning to participate in other investigational drug or device clinical trials for the duration of the study
- •Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
- •Unable to comply with study procedures or follow-up visits
研究组 & 干预措施
High Dose DE-120
Single 20 µL intravitreal injection of High Dose DE-120 injectable solution
干预措施: DE-120 (Drug)
Low Dose DE-120
Single 20 µL intravitreal injection of Low Dose DE-120 injectable solution
干预措施: DE-120 (Drug)
Medium Dose DE-120
Single 20 µL intravitreal injection of Medium Dose DE-120 injectable solution
干预措施: DE-120 (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: Each visit from Day 1 to Study Exit (Month 24)
Adverse events will be assessed at each visit to assess safety
Change from Baseline in macular volume
时间窗: Each visit from Day 1 through Study Exit (Month 24)
Macular volume will be measured using spectral domain optical coherence tomography (SD-OCT)
Change from Baseline in central subfield thickness (CST)
时间窗: Each visit from Day 1 through Study Exit (Month 24)
CST will be measured using spectral domain optical coherence tomography (SD-OCT)
Drug concentration in plasma over time after a single injection of DE-120
时间窗: Most visits from Day 1 through Study Exit (Month 24)
Pharmacokinetic assessments will include area under the plasma concentration time curve (AUC), peak plasma concentration (Cmax), time to peak plasma concentration (tmax) and elimination half life (t1/2)
次要结局
- Change from Baseline in ocular signs and symptoms(Each visit from Day 1 through Study Exit (Month 24))