Phase 1b/2a Open Label, Multiple-Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pilot Efficacy, Pharmacokinetics and Pharmacodynamic Effects of 28 Day Repeat Subcutaneous Doses of AKB-9778 in Subjects With Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Incidence and severity of adverse events (AEs).
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with diabetic macular edema (DME).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following is an abbreviated list of inclusion criteria:
- •Adults between 18 to 80 years of age, inclusive
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •Decrease in vision determined to be primarily the result of DME in the study eye
- •Definite Retinal thickening due to diffuse DME involving the center of the macula in the study eye
- •Mean central subfield thickness of at least 325 µm by OCT in the study eye
- •Early Treatment Diabetic Retinopathy Study (ETDRS) letter score BCVA ≤ 70 (20/40) in the study eye
排除标准
- •The following is an abbreviated list of exclusion criteria:
- •Hemoglobin A1C (HbA1C) ≥ 11.5%
- •History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):
- •Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening
- •Prior pars plana vitrectomy within 12 weeks prior to Screening
- •Any ocular surgery within 12 weeks prior to Screening
- •YAG capsulotomy within 7 days prior to Screening
- •Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Screening or prior treatment with intravitreal anti-VEGF treatment within 1 month of Screening
研究组 & 干预措施
AKB-9778
Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days.
干预措施: Subcutaneous AKB-9778 (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs).
时间窗: 28 days
Change from baseline in physical exams.
时间窗: 28 days
Change from baseline in vital signs.
时间窗: 28 days
Change from baseline in electrocardiograms (ECGs).
时间窗: 28 days
Change from baseline in opthalmic exams.
时间窗: 28 days
Change from baseline in clinical laboratory assay results.
时间窗: 28 days
Blood chemistry, hematology and urinalysis.
次要结局
- Pharmacokinetics of AKB-9778(Day 1 and Day 14)
- Change from baseline in optical tomography (OCT)-measured retinal thickness.(28 days)
- Change from baseline in best corrected visual acuity (BCVA).(28 days)