NCT03466099已完成2 期
A Randomized Sham-controlled Double-masked Phase 2a Study of the Efficacy, Safety and Tolerability of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema Who Have Had Prior Anti-vascular Endothelial Growth Factor Treatment
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
- 129
- 试验地点
- 2
- 主要终点
- BCVA
研究概览
简要总结
This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. The patients will be randomized to receive either a high dose, a low dose or a sham control treatment. The study will evaluate whether the new treatment improves vision and whether it changes the underlying course of the disease in the eye.
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
- •Confirmed diagnosis of Type I or Type II diabetes mellitus (DM).
- •BCVA of ≥19 letters (~20/400) and ≤73 letters (~20/40) in the study eye and ≥34 letters(~20/200 or better) in the fellow eye.
- •Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm in men
- •Subjects first anti-VEGF injection in the study eye occurred ≤36 months.
- •Subjects have received at least 3 anti-vascular endothelial growth factor (VEGF) injections in the study eye within a 6-month period.
- •The last anti-VEGF injection in the study eye is ≥ 8 weeks.
排除标准
- •Evidence of ocular pathology (e.g. visually significant cataract) that impacts subject's vision in the study eye from any cause other than DME.
- •Evidence/presence of amblyopia, vitreomacular traction, epiretinal membrane, foveal atrophy, or foveal ischemia, or any other condition in the macula that is thought to impair the subject's vision (other than DME).
- •Prior treatment with panretinal photocoagulation or focal grid macular photocoagulation in the study eye within the previous 3 months.
- •Prior treatment with intravitreal (IVT) steroid in the study eye (in the previous 3 months for triamcinolone, previous 6 months for Ozurdex and at any time for Iluvien).
- •Prior treatment with topical NSAIDs or topical steroids in the study eye within 1 month.
- •Prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within 3 months.
- •Prior vitrectomy in the study eye.
- •Prior intraocular surgery in the study eye except for cataract surgery. Cataract surgery within the previous 6 months in the study eye is excluded.
- •Intraocular pressure (IOP) of >22 mmHg in the study eye or use of >2 antiglaucoma agents (combination agents count as 2 agents) in the study eye.
- •Evidence of infectious dacrocystitis, significant blepharitis, active conjunctivitis, infectious keratitis, or scleritis in either eye, or any other condition that might affect the safety of the IVT injection.
- •Current active proliferative diabetic retinopathy (PDR), active anterior segment neovascularization (ASNV), active retinal neovascularization, or the presence of vitreous hemorrhage in the study eye.
- •Poorly controlled DM.
- •Uncontrolled hypertension
- •Prior treatment with ocriplasminin the study eye within 3 months
研究组 & 干预措施
KVD001 Injection (high dose)
Experimental
干预措施: KVD001 Injection (Drug)
KVD001 Injection (low dose)
Experimental
干预措施: KVD001 Injection (Drug)
Sham Procedure
Sham Comparator
干预措施: Sham Procedure (Other)
结局指标
主要结局
BCVA
时间窗: 16 weeks
Change from Baseline in Best Corrected Visual Acuity (BCVA)
次要结局
- DRSS(16 weeks)
- CST(16 weeks)
研究者
研究点 (2)
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