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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection. All subjects in Ranibizumab group will get Ranibizumab 0.2 mg/0.02 ml intravitreal injection just after the operation.
A week before 25-gauge vitrectomy, all subjects in TA group will receive Triamcinolone Acetonide 4mg/0.1ml intravitreal injection. During operation all subjects in Ranibizumab group and in TA group will be injected Triamcinolone Acetonide 4 mg/0.1ml. All subjects in TA group will get Triamcinolone Acetonide 1mg/0.025 ml intravitreal injection just after the operation.
The First People Hospital of Xuzhou
Xuzhou, Jiangsu, China
RECRUITINGintraoperative bleeding
Time frame: during operation of 25-G Vitrectomy
composite outcomes including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy
Time frame: 12 months after the last subject accepts vitrectomy
the change of Best-corrected visual acuity
Time frame: the change of best-corrected visual acuity at month 12 after vitrectomy
the change of inflammatory factors in vitreous body
Time frame: 7 days after the first injection
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