A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory 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
- 12
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
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
- •Provide signed written informed consent
- •Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration
- •Prior treatment in the study eye with any intravitreal anti-VEGF medication
- •At least one lesion in the study eye that meets minimal pathology criteria
- •Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye
- •Best corrected visual acuity of 20/200 or better in the fellow eye
- •Reasonably clear media and some fixation in the study eye
排除标准
- •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 or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
- •Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
- •Need for ocular surgery in the study eye during the course of the study
- •Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform required study assessments in either eye and/or confound study results
- •Allergy or hypersensitivity to study drug product, fluorescein dye or other study-related procedures and medications
- •Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
- •Participation in other investigational drug or device clinical trials within 30 days prior to randomization 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
Low Dose DE-122
Single intravitreal injection of DE-122 Low Dose Injectable Solution
干预措施: 0.5 mg of DE-122 (Drug)
Medium-Low Dose DE-122
Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution
干预措施: 1.0 mg of DE-122 (Drug)
Medium-High Dose DE-122
Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution
干预措施: 2.0 mg of DE-122 (Drug)
High Dose DE-122
Single intravitreal injection of DE-122 High Dose Injectable Solution
干预措施: 4.0 mg of DE-122 (Drug)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
时间窗: Baseline (Day1) and Day 90.
BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \[0, 97\] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision.
次要结局
- Change From Baseline in Central Subfield Thickness (CST) at Day 90.(Baseline (Day1) and Day 90.)