NCT02302079已完成2 期
A Phase 2, Double-Masked, Randomized, Active Controlled Study to Evaluate the Efficacy and Safety of ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 21
- 主要终点
- Percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence tomography (SD-OCT) at Month 3
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with diabetic macular edema (DME). This study will evaluate the percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% at Screening
- •Subject has definite retinal thickening due to diffuse diabetic macular edema (DME) involving the central macula based on evaluating investigator's clinical evaluation and demonstrated by spectral domain-optical coherence tomography (SD-OCT)
- •Subject has central subfield thickness (CST) of at least 375 μm by SD-OCT with presence of intraretinal and/or subretinal fluid at screening visit and at the randomization visit
- •Subject has early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit
排除标准
- •Subject's study eye has macular edema considered to be due to a cause other than DME
- •Subject's study eye has a decrease in BCVA due to causes other than DME that is likely to be decreasing BCVA by 3 lines or more
- •Subject's study eye has significant macular ischemia as shown on angiography
- •Subject's study eye has any other ocular disease that may cause substantial reduction in BCVA
- •Subject has active peri-ocular or ocular infection
- •Subject's study eye has a history of non-infectious uveitis
- •Subject's study eye has high myopia (-8 diopter or more correction)
- •Subject's study eye has a history of prior pars plana vitrectomy
- •Subject's study eye has a history of any ocular surgery within 3 months prior to Day 1
- •Subject's study eye has a history of YAG capsulotomy within 3 months prior to Day 1
- •Subject's study eye has a history of panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study through the Week 12 visit
- •Subject's study eye has a history of prior IVT, subtenon, or periocular, non-sustained release, steroid therapy within 3 months prior to Day 1
- •Subject's study eye has a history of intravitreal sustained release dexamethasone therapy within 6 months prior to Day
- •Subject's study eye has a history of intravitreal sustained release fluocinolone within 3 years prior to Day
- •Subject's study eye has a history of prior treatment for DME with IVT anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1
- •Subject has a history of prior treatment with any other (than previously listed) approved treatment which is not labeled for DME within 1 year prior to Day 1
- •Subject's study eye has high-risk proliferative diabetic retinopathy (PDR)
- •Subject has uncontrolled glaucoma
- •Subject has media clarity, papillary constriction (i.e., senile miosis), or subject lacks cooperation that would interfere with any study procedures, evaluations or interpretation of data
研究组 & 干预措施
ASP8232 + sham intravitreal (IVT) injections
Experimental
ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
干预措施: ASP8232 (Drug)
ASP8232 + sham intravitreal (IVT) injections
Experimental
ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
干预措施: Sham intravitreal (IVT) injection (Other)
ASP8232 + ranibizumab intravitreal (IVT) injections
Experimental
ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
干预措施: ASP8232 (Drug)
ASP8232 + ranibizumab intravitreal (IVT) injections
Experimental
ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
干预措施: ranibizumab (Drug)
Placebo + ranibizumab intravitreal (IVT) injections
Active Comparator
Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
干预措施: ranibizumab (Drug)
Placebo + ranibizumab intravitreal (IVT) injections
Active Comparator
Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence tomography (SD-OCT) at Month 3
时间窗: Baseline and Month 3
次要结局
- Absolute and percent change from baseline in excess CST in the study eye as assessed by SD-OCT at Months 1 and 2(Baseline and Months 1, 2)
- Change from baseline in early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) score in the study eye at Month 3(Baseline and Month 3)
- Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3(Baseline and Month 3)
研究者
研究点 (21)
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