EUCTR2017-003960-11-SK进行中（未招募）1 期
A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema (KITE)
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
- 356
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.Patients must give written informed consent before any study related assessments are performed
- •2.Patients =18 years of age at baseline
- •3.Patients with type 1 or type 2 diabetes mellitus and HbA1c of =10% at screening
- •4.Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study
- •5.Visual impairment due to DME with:
- •BCVA score between 78 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320), at screening and baseline
- •DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of =320 µm on SD-OCT at screening
- •If both eyes are eligible, the eye with the worse visual acuity will be selected for study eye. However, the investigator may select the eye with better visual acuity, based on medical reasons or local ethical requirements.
- •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 267
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 89
排除标准
- •1.Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye
- •2.Active proliferative diabetic retinopathy in the study eye as per the investigator
- •3.Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
- •4.Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline
- •5.Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
- •6.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
- •7.Neovascularization of the iris in the study eye at screening or baseline
- •8.Evidence of vitreomacular traction in the study eye at screening or baseline which, in the opinion of the investigator, affect visual acuity
研究者
相似试验
进行中（未招募）
1 期
Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edemadiabetic macular edemaMedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853EUCTR2017-003960-11-DEovartis Pharma AG356
进行中（未招募）
1 期
Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular EdemaEUCTR2017-003960-11-LVovartis Pharma AG356
进行中（未招募）
1 期
Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edemadiabetic macular edemaMedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853EUCTR2017-003960-11-BEovartis Pharma AG356
进行中（未招募）
1 期
Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edemadiabetic macular edemaMedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853EUCTR2017-003960-11-DKovartis Pharma AG356
进行中（未招募）
1 期
Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edemadiabetic macular edemaMedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853EUCTR2017-003960-11-SEovartis Pharma AG356