25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China: a Randomized, Single Blind Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- intraoperative bleeding
研究概览
简要总结
Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.
详细描述
Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic patients. The operation indication includes non-absorbed vitreous haemorrhage, dense bleeding in front of the macular, proliferative vitreoretinopathy traction macular, tractional retinal detachment combined break, severe progressive fiber vascular proliferation and vitreous haemorrhage combined with early iris neovascularization.
Due to VEGF levels rise in vitreous cavity of PDR patients, some inflammatory cytokines involved in, make easy bleeding during surgery and heavier inflammatory reaction postoperation,thus affecting the curative effect of the operation.
Ranibizumab as angiogenesis inhibitors, has widely applied in the treatment of age-related macular degeneration, won the recognition of ophthalmologists.
Some scholars try to expand the application in diabetic macular edema, also obtained the good curative effect.Some scholars also applied the angiogenesis inhibitors to the diabetes retinopathy before surgery in the hope to reduce the occurrence of intraoperative bleeding.Compared with bevacizumab, the short half-life of lucentis, and thus reduce the inhibition of VEGF system risk.
In this project, the investigators will inject lucentis into vitreous cavity before surgery of PDR, and observe the effect and complications of the operation, compared with triamcinolone acetonide group(the control group); At the same time the cytokines level of VEGF, pigment epithelium-derived factor (PEDF), epidermal growth factor (EGF), Transforming Growth Factor-beta (TGF-beta), interleukin 6 (IL - 6) and interleukin 8 (IL - 8) will be detected before and after pretreatment with lucentis or triamcinolone acetonide, and the cytokines concentration change will be compared between two groups, the mechanism of PDR will be further clarified and theoretical basis for looking for treatment strategies will be a set.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II diabetes mellitus with Diabetic Retinopathy
- •Vitreous hemorrhage/Proliferation of retinal/Tractional detachment of retina
排除标准
- •Fasting blood-glucose more than 8mmol/ml
- •Subjects who have operation on vitreous before
- •Accompany with other ophthalmology diseases except cataract
- •History of vitrectomy surgery in the study eye
- •Previous subfoveal focal laser photocoagulation in the study eye
- •Previous participation in a clinical trial (for either eye)
- •Previous subfoveal focal laser photocoagulation in the study eye
- •Other diseases cannot afford Vitrectomy
研究组 & 干预措施
Ranibizumab
A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection.
During operation all subjects in this group will be injected Triamcinolone Acetonide 4 mg/0.1ml.
All subjects in this group will get Ranibizumab 0.2 mg/0.02 ml intravitreal injection just after the operation.
干预措施: Ranibizumab (Drug)
Ranibizumab
A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection.
During operation all subjects in this group will be injected Triamcinolone Acetonide 4 mg/0.1ml.
All subjects in this group will get Ranibizumab 0.2 mg/0.02 ml intravitreal injection just after the operation.
干预措施: Triamcinolone Acetonide (Drug)
Triamcinolone Acetonide
A week before 25-gauge vitrectomy, all subjects in Triamcinolone Acetonide group will receive Triamcinolone Acetonide 4mg/0.1 ml intravitreal injection.
During operation all subjects in this group will be injected Triamcinolone Acetonide 4 mg/0.1ml.
All subjects in this group will get Triamcinolone Acetonide 1mg/0.025 ml intravitreal injection just after the operation.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
intraoperative bleeding
时间窗: during operation of 25-G Vitrectomy
次要结局
- composite outcomes including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy(12 months after the last subject accepts vitrectomy)
- the change of inflammatory factors in vitreous body(7 days after the first injection)
- the change of Best-corrected visual acuity(the change of best-corrected visual acuity at month 12 after vitrectomy)
研究者
JUNYAN ZHANG
Senior Consultant and Statistician
The First People's Hospital of Xuzhou