Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02447185
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : September 24, 2018
Sponsor:
Collaborator:
The First People's Hospital of Xuzhou
Information provided by (Responsible Party):
JUNYAN ZHANG, The First People's Hospital of Xuzhou

Tracking Information
First Submitted Date  ICMJE May 14, 2015
First Posted Date  ICMJE May 18, 2015
Last Update Posted Date September 24, 2018
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
intraoperative bleeding [ Time Frame: during operation of 25-G Vitrectomy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02447185 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
  • composite outcomes including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy [ Time Frame: 12 months after the last subject accepts vitrectomy ]
  • the change of Best-corrected visual acuity [ Time Frame: the change of best-corrected visual acuity at month 12 after vitrectomy ]
  • the change of inflammatory factors in vitreous body [ Time Frame: 7 days after the first injection ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 25-G Vitrectomy With Ranibizumab or Triamcinolone Acetonide on PDR in China-Randomized Clinical Trial
Official Title  ICMJE 25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China: a Randomized, Single Blind Trial
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 a set.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Proliferative Diabetic Retinopathy
Intervention  ICMJE
  • Drug: Ranibizumab

    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.

    Other Names:
    • rhuFab V2
    • Lucentis
  • Drug: Triamcinolone Acetonide

    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.

    Other Names:
    • Vitreal S
    • Cinonide
    • Tricort 40
    • Kenalog
Study Arms  ICMJE
  • Experimental: Ranibizumab

    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.

    Interventions:
    • Drug: Ranibizumab
    • Drug: Triamcinolone Acetonide
  • Active Comparator: Triamcinolone Acetonide

    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.

    Intervention: Drug: Triamcinolone Acetonide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: SUYAN LI, MD +86-13852101175 lisuyan1226@126.com
Contact: XINTING WANG, Med Master +86-15950664745 xintinghappy1017@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02447185
Other Study ID Numbers  ICMJE PDR-RAN-RCT-LSY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party JUNYAN ZHANG, The First People's Hospital of Xuzhou
Study Sponsor  ICMJE JUNYAN ZHANG
Collaborators  ICMJE The First People's Hospital of Xuzhou
Investigators  ICMJE
Principal Investigator: SUYAN LI, MD Ophthalmology Department of the 1st People Hospital of Xuzhou
PRS Account The First People's Hospital of Xuzhou
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP