NCT01042678终止1 期
A Phase I/II, Open-label, Single Ascending Dose Study Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of Intravitreal MP0112 in Patients With Diabetic Macular Edema (DME)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 years or older
- •Macular edema due to diabetic retinopathy
- •Best-corrected visual acuity in the study eye of 20/40 to 20/400
- •Central subfield thickness ≥ 250 microns by OCT
- •Females of childbearing potential must have a negative serum pregnancy test at Screening
- •Male subjects must or be: 1) surgically sterilized for at least 6 months, or 2) use an appropriate method of barrier contraception (e.g., condoms with spermicide) and advise any sexual partner of child-bearing potential that she must also use a reliable method of contraception (e.g., hormonal contraceptive, intrauterine device, diaphragm with spermicide) during the study and for 30 days from study drug administration.
- •Ability to understand the nature of the study and give written informed consent
- •Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
排除标准
- •Any indication of irreversible vision loss such as significant atrophy, scarring, fibrosis, or hyperpigmentation in the fovea
- •Presence of significant ocular abnormalities in the study eye that prevent retinal assessment, including media opacities, cataract, or inadequate papillary dilation
- •Presence of vision loss from another ocular disease other than DME
- •History of any intraocular surgery within 3 months of Baseline
- •History of intraocular injection of anti-VEGF agent or steroids within 3 months of Baseline
- •History of laser photocoagulation for macular edema within 4 months prior to Baseline
- •Uncontrolled hypertension > 140 systolic or > 95 diastolic
- •HbA1C ≥ 12%
- •Creatinine: > 1.5 x upper limit of normal (ULN)
- •Alanine transaminase (ALT), aspartate transaminase (AST), and gamma-glutamyl transferase (GGT): > ULN
- •White blood cells (WBC), hematocrit, and platelets: < lower limit of normal (LLN)
- •Heart rate < 60 beats per minute (bpm) or history of clinically significant bradycardia
- •History of human immunodeficiency virus (HIV), chronic hepatitis B, or chronic hepatitis C infections
- •Subjects with infections requiring hospitalization and/or antibiotic treatment 14 days prior to Baseline
- •Subjects with any medical condition that in the judgment of the investigator could poise unacceptable risk to the subject or compromise interpretation of the data to be collected
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: 16 weeks
Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
次要结局
- Serum Levels of MP0112(16 Weeks)
- Best-Corrected Visual Acuity (BCVA)(Baseline, Week 16)
- Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)(Baseline, Week 16)
- Aqueous Humor Levels of MP0112(1 Week)
- Number of Participants With Positive Binding Anti-MP0112 Antibodies(12 weeks)
研究者
研究点 (8)
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