25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China
Keywords
Abstract
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 laid.
Dates
| Last Verified: | 07/31/2016 |
| First Submitted: | 12/19/2014 |
| Estimated Enrollment Submitted: | 12/25/2014 |
| First Posted: | 12/30/2014 |
| Last Update Submitted: | 08/22/2016 |
| Last Update Posted: | 08/24/2016 |
| Actual Study Start Date: | 01/31/2015 |
| Estimated Primary Completion Date: | 02/28/2017 |
| Estimated Study Completion Date: | 04/30/2017 |
Condition or disease
Intervention/treatment
Drug: Ranibizumab 0.5 mg
Drug: Triamcinolone Acetonide
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Ranibizumab 0.5 mg All subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection. | Drug: Ranibizumab 0.5 mg A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection. All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation. |
| Experimental: Triamcinolone Acetonide 4mg All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Type II diabetes mellitus with Diabetic Retinopathy - Vitreous hemorrhage/Proliferation of retinal/Tractional detachment of retina - Fasting blood-glucose no more than 8mmol/ml Exclusion Criteria: - 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 |
Outcome
Primary Outcome Measures
1. composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy [12 months after the last subject accepts vitrectomy]
Secondary Outcome Measures
1. the change of Best-corrected visual acuity [the change of best-corrected visual acuity at month 12 after vitrectomy]
2. the change of inflammatory factors in vitreous body [7 days after injection]
