CTRI/2020/09/028038已完成3 期
A 96-week, two-arm, randomized, single-masked, multi-center, phase III study assessing the efficacy and safety of brolucizumab 6mg compared to panretinal photocoagulation laser in patiemts with proliferative diabetic retinopathy
Novartis Healthcare Pvt Ltd6 个研究点 分布在 1 个国家目标入组 706 人开始时间: 2020年12月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 706
- 试验地点
- 6
- 主要终点
- To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from BAseline in visual acuity at week 54
研究概览
简要总结
To evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Patients olde than or equal to 18 years of age at screening.
- •Participant cooperation sufficient for adequate fundus photographs and retinal images.
- •Patients diagnosed with type 1 or 2 DM and HbA1c more than or equal to 12 percent at screening.
- •Any medication administered for the management od DM should be stable within 3 months prior to randomization and is expected to remain stable during the course of the study, as medically acceptable.
- •PDR as assesses by the investigator using standard or wide-field CFP and FA with no evidence of previous PRP, and that requires treatment with either anti-VEGF or PRP in the opinion of the investigator.
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
To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from BAseline in visual acuity at week 54
时间窗: week 54
次要结局
- To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at week 54(Proportion of subjects with no PDR at week 54)
- To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to week 54(Proportion of subjects with center-involved DME up to week 54)
- To compare the effect of brolucizumab relative to PRP with respect to visual acuity(Area under the curve in change from BAseline in BCVA up to week 54 and week 96)
研究者
研究点 (6)
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