Clinical trial NCT02328118: 25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China
Official title: 25-Gauge Vitrectomy Combine With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in Chinese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Proliferative Diabetic Retinopathy
Keywords: Lucentis
Ranibizumab
Triamcinolone Acetonide
Vitrectomy
PDR
Lead sponsor: The First People's Hospital of Xuzhou
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Xuzhou
First posted: 2014-12-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy
timeFrame: 12 months after the last subject accepts vitrectomy
Secondary outcomes:
measure: the change of Best-corrected visual acuity
timeFrame: the change of best-corrected visual acuity at month 12 after vitrectomy
measure: the change of inflammatory factors in vitreous body
timeFrame: 7 days after injection
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The First People Hospital of Xuzhou
state: Jiangsu
Study officials:
affiliation: Ophthalmology Department of the 1st People Hospital of Xuzhou
name: SUYAN LI, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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