EUCTR2019-001004-37-HU进行中（未招募）1 期
A 12-month, 2-arm, randomized, double-masked, multicenter Phase III study assessing the efficacy and safety of brolucizumab versus aflibercept in patients with visual impairment due to Diabetic Macular Edema (KINGFISHER)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 495
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
- •1- Signed informed consent must be obtained prior to participation in the study
- •2- Patients to be 18 years of age or over at baseline
- •3- Patients with type 1 or type 2 diabetes mellitus and HbA1c = 12% at screening
- •3- Patients with visual impairment due to DME with
- •-BCVA score between 73 and 23 letters, inclusive, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/40 to 20/320) at both screening and baseline.
- •-DME involving the center of the macula, with CSFT = 320 µm on SD-OCT at screening
- •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 371
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 124
排除标准
- •Ocular conditions
- •-High-risk proliferative diabetic retinopathy (PDR) in the study eye as per investigator assessment at both screening and baseline
- •-Concomitant conditions or ocular disorders in the study eye at screening or baseline which may, in the opinion of the investigator, confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period (eg, structural
- •damage of the fovea, vitreous hemorrhage, retinal detachment, vitreomacular traction, macular hole, retinal vein/arterial occlusion,
- •neovascularization of iris or choroidal neovascularization (CNV) of any cause).
- •-Any active intraocular or periocular infection or active intraocular inflammation in the either eye at screening or baseline.
- •-Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator’s judgment at
- •screening or baseline
- •-Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200 at screening (except when due to conditions whose surgery
- •may improve VA, eg, cataract)
- •Ocular treatments
- •-Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to
- •-Use of intraocular or periocular corticosteroids including dexamethasone intravitreal implant (Ozurdex) in the study eye during the 6-month period
- •prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline
- •-Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline
研究者
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