NCT06899529招募中不适用
Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
Christian Ophthalmic Surgery Expedition Network1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
Patients undergoing surgery for complications related to diabetes will be recruited.
详细描述
Proliferative Diabetic Retinopathy patients undergoing pars plana vitrectomy will be randomized whether or not to receive intravitreal bevacizumab at the conclusion of the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and the specialist recording outcomes will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age is > 18
- •Subject consents to study participation and is capable of 6 months of follow-up.
- •The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
- •Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to Hand Motions in the study eye.
- •The subject is determined to need a PPV because of reduced BCSVA principally from a non-clearing vitreous hemorrhage, TRD, fibrous proliferation, or a combination of the three. When non-clearing vitreous hemorrhage is the principal reason for PPV, the hemorrhage must have been present by subjective history for at least 3 months. When TRD is the principal reason for PPV, the TRD must be threatening (within one disc diameter) or involving the fovea. When fibrovascular proliferation is the principal reason for PPV, it must be extensive (>3 clock hours) and threatening (within one disc diameter) or involving the fovea.
- •Only one eye per patient is eligible for the study.
排除标准
- •Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
- •Subject has a significant corneal opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
- •Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
- •Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
- •Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
研究组 & 干预措施
Control Group
No Intervention
Does NOT receive postoperative bevacizumab
Treatment Group
Active Comparator
Receives postoperative bevacizumab
干预措施: Bevacizumab (Procedure)
结局指标
主要结局
Primary Outcome
时间窗: 6 months
Postoperative vitreous hemorrhage rate
次要结局
未报告次要终点
研究者
研究点 (1)
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