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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China: a Randomized, Single Blind Trial

Conditions
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Proliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: Ranibizumab
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab<br>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. | Drug: Ranibizumab<br>* 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.<br>* Other names: Lucentis;Drug: Triamcinolone Acetonide<br>* 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.<br>* Other names: Kenalog;|
| Active Comparator: Triamcinolone Acetonide<br>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. | Drug: Triamcinolone Acetonide<br>* 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.<br>* Other names: Kenalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative bleeding |  | during operation of 25-G Vitrectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite outcomes including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy |  | 12 months after the last subject accepts vitrectomy | 
| the change of Best-corrected visual acuity |  | the change of best-corrected visual acuity at month 12 after vitrectomy | 
| the change of inflammatory factors in vitreous body |  | 7 days after the first injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDR, Lucentis, Ranibizumab, Triamcinolone Acetonide, Vitrectomy, 25-Gauge Vitrectomy