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

Information source: The First People's Hospital of Xuzhou
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Proliferative Diabetic Retinopathy

Intervention: Ranibizumab (Drug); Triamcinolone Acetonide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: JUNYAN ZHANG

Official(s) and/or principal investigator(s):
SUYAN LI, MD, Principal Investigator, Affiliation: Ophthalmology Department of the 1st People Hospital of Xuzhou

Overall contact:
SUYAN LI, MD, Phone: +86-13852101175, Email: lisuyan1226@126.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: intraoperative bleeding

Secondary outcome:

composite outcomes including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy

the change of Best-corrected visual acuity

the change of inflammatory factors in vitreous body

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 a set.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

SUYAN LI, MD, Phone: +86-13852101175, Email: lisuyan1226@126.com

The First People Hospital of Xuzhou, Xuzhou, Jiangsu 221002, China; Recruiting
Suyan Li, Doctor, Phone: +86-13852101775, Email: lisuyan1226@126.com
Junyan Zhang, Bachelor, Phone: +86-13701739364, Email: richard.zhang@both-win.net
Additional Information

Starting date: June 2015
Last updated: June 5, 2015

Page last updated: August 23, 2015

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