jRCT2031200194进行中（未招募）不适用
A 96-week, two-arm, randomized, single-masked, multicenter, phase III study assessing the efficacy and safety of brolucizumab 6 mg compared to panretinal photocoagulation laser in patients with proliferative diabetic retinopathy
Novartis Pharma. K.K.0 个研究点目标入组 50 人开始时间: 2021年1月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 主要终点
- Change from Baseline in BCVA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Signed informed consent must be obtained prior to participation
- •Able to complete adequate fundus photographs and retinal images
- •Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
- •DM treatment stable for at least 3 months
- •PDR diagnosis with no previous PRP treatment in the study eye
排除标准
- •Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
- •Presence of diabetic macular edema in the study eye Active infection or inflammation in the study eye
- •Uncontrolled glaucoma (IOP greater than 25 mmHg)
- •Intravitreal anti-VEGF treatment within 6 months
- •Treatment with intraocular corticosteroids
- •End stage renal disease requiring dialysis or kidney transplant
- •Uncontrolled blood pressure
- •Systemic anti-VEGF therapy at any time Other protocol-defined inclusion/exclusion criteria may apply"
结局指标
主要结局
Change from Baseline in BCVA
时间窗: Week 54
to demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity
次要结局
未报告次要终点
研究者
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