Open-Label Study of the Safety and Efficacy of Suprachoroidal CLS-TA Alone or in Combination With Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
研究概览
简要总结
This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.
详细描述
This is a Phase 1/2, multicenter, open-label study in subject with DME associated with diabetes mellitus.
Subjects will be screened and if eligible, will be assigned to study arm at the Baseline Visit (Visit 1, Day 0).
Following the Baseline Visit, subjects will participate in six monthly follow-up visits (Visit 2-7; Weeks 4-24) for safety and efficacy assessments and to determine whether additional therapy is needed based upon pre-defined criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Men or women ≥ 18 years of age with type 1 or type 2 diabetes mellitus
- •DME with central involvement (>320 microns in the central subfield on SD-OCT) in the study eye
- •ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye
排除标准
- •Evidence of DME due to any other cause other than diabetes mellitus in the study eye
- •PRP or focal laser photocoagulation in the study eye within 90 days of screening
- •Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye
- •History of any previous ophthalmic surgeries in the study eye within 90 days of screening
- •High risk PDR in the study eye, for whom enrollment into the study, in the principal investigator's opinion would put the eye at undue risk for vision loss
- •Any previous treatment in the study eye with ILUVIEN implant
- •Previous treatment for DME in the study eye (TX naive arm only); treatment in the study eye for DME greater than 1 year prior to screening can be considered as treatment naive, at the investigator's discretion
- •Subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only)
- •Subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only)
研究组 & 干预措施
TX Naïve Arm
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
干预措施: SC CLS-TA (Drug)
TX Naïve Arm
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
干预措施: IVT Aflibercept (Drug)
Previous TX Arm
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
干预措施: SC CLS-TA (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
时间窗: Over 6 months of follow-up
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
次要结局
- CLS-TA Injections(2 to 6 months following initial treatment with study drug)
- Mean Change From Baseline in Intraocular Pressure(Baseline and 6 months)
- Mean Change From Baseline in Central Subfield Thickness(Baseline and 6 months)
- Best Corrected Visual Acuity(Baseline and 6 months)