NCT06116916进行中（未招募）2 期
A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients 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
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 87
- 主要终点
- Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
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
- •Voluntary written informed consent to participate in the study
- •In Korea, participants must be 19 years or older to be enrolled
- •BCVA ETDRS letter score of 78 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening
- •500 μm ≥ CST ≥ 325 μm in the study eye at screening
- •HbA1c ≤ 11% at screening
排除标准
- •Any signs of proliferative diabetic retinopathy in the study eye
- •History of rubeosis in the study eye
- •Uncontrolled glaucoma in the study eye
- •Aphakia or pseudophakia with AC-IOL in the study eye
- •Active intraocular inflammation in the study eye
- •Any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye
- •History of rhegmatogenous retinal detachment in the study eye
- •Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- •History of the following therapies in the study eye
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for DME
- •Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids
- •Previous intraocular device implantation except PC-IOL
- •Laser (any type) to the macular area within 12 weeks prior to Day 1
- •Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1
- •Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars
- •Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day
- •Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with DME within 3 years prior to Day 1
- •Previous use of Ozurdex® or Iluvien® implant
- •Any current or history of endophthalmitis in either eye
- •History of idiopathic or autoimmune-associated uveitis in either eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
研究组 & 干预措施
Arm A
Experimental
KHK4951 High dose
干预措施: KHK4951 (Drug)
Arm A
Experimental
KHK4951 High dose
干预措施: Aflibercept Injection (Drug)
Arm B
Experimental
KHK4951 Middle dose
干预措施: KHK4951 (Drug)
Arm B
Experimental
KHK4951 Middle dose
干预措施: Aflibercept Injection (Drug)
Arm C
Experimental
KHK4951 Low dose
干预措施: KHK4951 (Drug)
Arm C
Experimental
KHK4951 Low dose
干预措施: Aflibercept Injection (Drug)
结局指标
主要结局
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
时间窗: For 36 weeks until the end of the trial
次要结局
- The number of aflibercept IVT(For 36 weeks until the end of the trial)
- Change from baseline in leakage as measured by FA(36 Weeks)
- Change from baseline in SHRM as measured by SD-OCT(36 Weeks)
- Change from baseline in retinal morphology as measured by SD-OCT(36 Weeks)
研究者
研究点 (87)
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