Randomized, Double Masked, Controlled Study Comparing the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 29
- 主要终点
- Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
研究概览
简要总结
The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.
详细描述
This is a Phase 2, multicenter, randomized, double-masked, controlled, parallel-group study of 6 months duration in treatment-naïve subjects with DME. This study is projected to enroll approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups.
The study design includes up to 8 clinic visits over approximately 24 weeks. Subjects will attend visits for Screening (Visit 1, Days -30 to 0); Randomization and Baseline (Visit 2, Day 0 before dosing); Dosing and Evaluation (Visit 2 after dosing to Visit 5, Day 0 through Week 12); As-needed (PRN) Dosing and Follow up (Visit 6 through Visit 7, Week 16 through Week 20), and End of Study (Visit 8, Week 24).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of type 1 or type 2 DM
- •DME with central involvement (> 300 µm in the central subfield on spectral-domain optical coherence tomography [SD-OCT], in the study eye
- •ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
- •Naïve to local pharmacologic treatment for DME in the study eye
排除标准
- •IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication
- •Any previous treatment in the study eye with an ocular corticosteroid implant
- •Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
- •History of glaucoma or optic nerve head change consistent with glaucoma damage
- •History of glaucoma surgery
- •History of clinically significant IOP elevation in response to corticosteroid treatment ("steroid responder")
研究组 & 干预措施
Active
Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
干预措施: IVT aflibercept (Drug)
Active
Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
干预措施: SC CLS-TA (Drug)
Control
Treatment will consist of IVT aflibercept injection followed by a sham SC procedure
干预措施: IVT aflibercept (Drug)
Control
Treatment will consist of IVT aflibercept injection followed by a sham SC procedure
干预措施: Sham SC (Drug)
结局指标
主要结局
Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
时间窗: Baseline, 6 months
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
次要结局
- Mean Change From Baseline in Central Subfield Thickness(Baseline, 6 months)