A Randomized Controlled Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The number of fundus neovascularization seen in FFA.
研究概览
简要总结
The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.
Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points.
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
- Single (Outcomes Assessor)
盲法说明
Participants and operating surgeons were not masked to the assigned surgical interval. Intraoperative fluorescein angiography recordings were anonymized and coded before assessment, and outcome assessors grading the images were masked to treatment allocation.
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
- •PDR is diagnosed in people 18 years of age or older with type 1 or type 2 diabetes，
- •Hemoglobin A1c (HbA1c) ≤10%
- •Persistent vitreous hemorrhage for more than one month or recurrent vitreous hemorrhage (within six months)
- •Did not undergo retintis photocoagulation (PRP)
- •Vitreous hemorrhage disease course within six months
排除标准
- •Patients who have had previous vitreoretinal surgery
- •Intravitreal drug injection within 3 months
- •Eye diseases other than PDR that may hinder vision improvement, such as optic atrophy or macular hole
- •Thromboembolic events (including cerebrovascular or myocardial infarction) or clotting system disorders or receiving anticoagulation or antiplatelet therapy
- •B-ultrasound or indirect fundus microscopy showing retina detachment (pull or hole origin)
- •Vitrectomy, FFA contraindicated patients, patients with severe abnormality of cardiopulmonary, liver and kidney function
研究组 & 干预措施
3-Day Conbercept-to-Vitrectomy Interval
Participants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 3 days before pars plana vitrectomy.
干预措施: Time (Other)
7-Day Conbercept-to-Vitrectomy Interval
Participants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 7 days before pars plana vitrectomy.
干预措施: Time (Other)
14-Day Conbercept-to-Vitrectomy Interval
Participants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 14 days before pars plana vitrectomy.
干预措施: Time (Other)
结局指标
主要结局
The number of fundus neovascularization seen in FFA.
时间窗: Observed during operation
Fundus neovascularization
The area of fundus neovascularization seen in FFA (using PD size as measurement).
时间窗: Observed during operation
Fundus neovascularization
The intensity of neovascularization fluorescein leakage
时间窗: Observed during operation
2- and 5-minute images were taken to assess the intensity of neovascularization fluorescein leakage through FFA.Fluorescein leakage intensity classification and leakage score (judged by postoperative video or jigsaw puzzle) : no leakage is 0; The suspected leakage was level 1. It is clear that the expansion range of leakage point is less than 1PD, which is grade 2. It is clear that leakage greater than or equal to 1PD is grade 3; Leakage integral is the sum of leakage number x leakage strength classification.
Number of Active Retinal Neovascularization Tufts Assessed by Intraoperative Fluorescein Angiography
时间窗: Intraoperatively, 1 to 3 minutes after fluorescein injection
Number of active retinal neovascularization tufts identified on intraoperative fluorescein angiography images.
Size of Active Retinal Neovascularization Assessed by Intraoperative Fluorescein Angiography
时间窗: Intraoperatively, 1 to 3 minutes after fluorescein injection
Neovascularization size was quantified by measuring the maximal linear diameter and normalizing it to the vertical optic disc diameter, expressed in papillary diameters (PD).
次要结局
未报告次要终点
研究者
Jie Li
Principal Investigator
Sichuan Provincial People's Hospital