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

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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

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.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: Ranibizumab Drug: Triamcinolone Acetonide Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China: a Randomized, Single Blind Trial
Study Start Date : June 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
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.

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

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.

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




Primary Outcome Measures :
  1. intraoperative bleeding [ Time Frame: during operation of 25-G Vitrectomy ]

Secondary Outcome Measures :
  1. composite outcomes including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy [ Time Frame: 12 months after the last subject accepts vitrectomy ]
  2. the change of Best-corrected visual acuity [ Time Frame: the change of best-corrected visual acuity at month 12 after vitrectomy ]
  3. the change of inflammatory factors in vitreous body [ Time Frame: 7 days after the first injection ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447185


Contacts
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Contact: SUYAN LI, MD +86-13852101175 lisuyan1226@126.com
Contact: XINTING WANG, Med Master +86-15950664745 xintinghappy1017@sina.com

Locations
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China, Jiangsu
The First People Hospital of Xuzhou Recruiting
Xuzhou, Jiangsu, China, 221002
Contact: Suyan Li, Doctor    +86-13852101775    lisuyan1226@126.com   
Contact: Junyan Zhang, Bachelor    +86-13701739364    richard.zhang@both-win.net   
Sponsors and Collaborators
JUNYAN ZHANG
The First People's Hospital of Xuzhou
Investigators
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Principal Investigator: SUYAN LI, MD Ophthalmology Department of the 1st People Hospital of Xuzhou

Publications of Results:

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Responsible Party: JUNYAN ZHANG, Senior Consultant and Statistician, The First People's Hospital of Xuzhou
ClinicalTrials.gov Identifier: NCT02447185     History of Changes
Other Study ID Numbers: PDR-RAN-RCT-LSY
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by JUNYAN ZHANG, The First People's Hospital of Xuzhou:
Lucentis
Ranibizumab
Triamcinolone Acetonide
Vitrectomy
PDR
25-Gauge Vitrectomy
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action