JPRN-jRCT2031230400招募中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
Takigawa Sotaro0 个研究点目标入组 117 人开始时间: 2023年10月16日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 117
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Voluntary written informed consent to participate in the study
- •-BCVA ETDRS letter score of 73 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening
- •-500 micrometre >= CST >= 325 micrometre in the study eye at screening
- •-HbA1c <= 11 percent 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
- •-Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids
- •-Previous intraocular device implantation except PC-IOL
- •-Previous laser (any type) to the macular area
- •-Previous panretinal photocoagulation treatment
- •-Previous treatment with any IVT anti-VEGF drugs
- •-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
研究者
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