Proliferative Diabetic Retinopathy Clinical Trial
Official title:
25-Gauge Vitrectomy Combine With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in Chinese Patients
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
laid.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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