25-G Vitrectomy With Ranibizumab or Triamcinolone Acetonide on PDR in China-Randomized Clinical Trial

  • STATUS
    Recruiting
  • End date
    Dec 22, 2021
  • participants needed
    200
  • sponsor
    JUNYAN ZHANG
Updated on 22 January 2021
diabetes
vegf
type 2 diabetes mellitus
bevacizumab
adjuvant therapy
vascular endothelial growth factor
ranibizumab
retinopathy
detachment
vitrectomy
visual loss
vitreous hemorrhage

Summary

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.

Description

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.

Details
Condition Proliferative Diabetic Retinopathy
Treatment triamcinolone acetonide, ranibizumab
Clinical Study IdentifierNCT02447185
SponsorJUNYAN ZHANG
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Proliferative Diabetic Retinopathy?
Do you have any of these conditions: Do you have Proliferative Diabetic Retinopathy??
Type II diabetes mellitus with Diabetic Retinopathy
Vitreous hemorrhage/Proliferation of retinal/Tractional detachment of retina

Exclusion Criteria

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
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