EUCTR2018-000031-28-ES进行中（未招募）1 期
A randomized, active-controlled, patient and investigator-masked, multiple dose proof-of-concept study of intravitreal LKA651 in patients with diabetic macular edema
ovartis Farmacéutica, S.A.0 个研究点目标入组 91 人开始时间: 2018年10月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients age 18 to 90 years of age inclusive
- •Diagnosis of type I or type II diabetes mellitus.
- •The Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be =34 letters or better (approximate Snellen equivalent of 20/200) at screening
- •Presence of DME in the study eye, with decrease in vision due to foveal thickening of central macular thickness = 275 µm in the central subfield, as assessed on spectral-domain ocular coherence tomography (SD-OCT) and confirmed by the central reading center
- •Sufficiently clear ocular media and adequate pupil dilation in the study eye to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •Patient with history of IVT anti-vascular endothelial growth factor (VEGF) treatment, macular laser photocoagulation, or intravitreal or topical steroid treatment in the study eye. History of topical steroid >6 months from study start for treatment of non-DME condition is allowed. History of focal laser treatment outside 1000 µm of the fovea in the study eye is permitted. History or concurrent treatment with these medications/procedures in the non-study eye is permitted.
- •Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage. Proliferative diabetic retinopathy in the study eye for which only focal, peripheral retinal areas were treated with photocoagulation with fewer than 30 laser burns performed at least 6 months preceding Day 1 is permitted.
- •Patients, with type 1 or type 2 diabetes who have a hemoglobin A1C = 12% at screening.
- •Any progressive disease of the retina in the study eye (e.g. uveitis, rod-cone dystrophy) or optic nerve (e.g. glaucoma) other than those listed in the inclusion criteria.
- •Area of retinal ischemia (as measured by the foveal avascular zone) = 1000 µm. Any other retinal ischemia not involving the foveal center but located = 1000 µm from the center of the macula of the study eye as assessed by fluorescein angiography (FA) at screening.
- •Active intraocular inflammation (graded as trace or above) in either eye or active intraocular infection in the study eye.
- •Current diagnosis of or laboratory evidence for anemia, defined as a hemoglobin <11 g/dL for women and <12 g/dL for men.
研究者
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