25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China (RaTAPDR)

August 23, 2016 updated by: JUNYAN ZHANG

25-Gauge Vitrectomy Combine With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in Chinese Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221002
        • Recruiting
        • The First People Hospital of Xuzhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab 0.5 mg
All subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection.
Drug: Ranibizumab
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.
Other Names:
  • Lucentis
  • rhuFab V2
Drug: Triamcinolone Acetonide
A week before 25-gauge vitrectomy, all subjects in Triamcinolone Acetone group will receive Triamcinolone Acetone 4mg/0.1 ml intravitreal injection. All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
Other Names:
  • Kenalog
  • Vitreal S
  • Cinonide
  • Tricort 40
Experimental: Triamcinolone Acetonide 4mg
All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
Drug: Triamcinolone Acetonide
A week before 25-gauge vitrectomy, all subjects in Triamcinolone Acetone group will receive Triamcinolone Acetone 4mg/0.1 ml intravitreal injection. All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
Other Names:
  • Kenalog
  • Vitreal S
  • Cinonide
  • Tricort 40

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy
Time Frame: 12 months after the last subject accepts vitrectomy
12 months after the last subject accepts vitrectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of Best-corrected visual acuity
Time Frame: the change of best-corrected visual acuity at month 12 after vitrectomy
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 injection
Compare the change of inflammatory factors in vitreous chamber between two groups. These inflammatory factors including VEGF/PEDF,EGF/TGF-beta, IL-6 and IL-8. This is only focus before vitrectomy
7 days after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JUNYAN ZHANG

Collaborators

The First People's Hospital of Xuzhou

Investigators

  • Principal Investigator: SUYAN LI, doctor, Ophthalmology Department of the 1st People Hospital of Xuzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

December 20, 2014

First Submitted That Met QC Criteria

December 26, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDR-RAN-LSY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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