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

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ranibizumab
Triamcinolone Acetonide
Sponsored by
JUNYAN ZHANG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Lucentis, Ranibizumab, Triamcinolone Acetonide, Vitrectomy, PDR

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First People Hospital of XuzhouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ranibizumab 0.5 mg

Triamcinolone Acetonide 4mg

Arm Description

All subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection.

All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the change of Best-corrected visual acuity
the change of inflammatory factors in vitreous body
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

Full Information

First Posted
December 20, 2014
Last Updated
August 23, 2016
Sponsor
JUNYAN ZHANG
Collaborators
The First People's Hospital of Xuzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02328118
Brief Title
25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China
Acronym
RaTAPDR
Official Title
25-Gauge Vitrectomy Combine With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in Chinese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JUNYAN ZHANG
Collaborators
The First People's Hospital of Xuzhou

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Lucentis, Ranibizumab, Triamcinolone Acetonide, Vitrectomy, PDR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab 0.5 mg
Arm Type
Experimental
Arm Description
All subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection.
Arm Title
Triamcinolone Acetonide 4mg
Arm Type
Experimental
Arm Description
All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis, rhuFab V2
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Vitreal S, Cinonide, Tricort 40, Kenalog
Intervention Description
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.
Primary Outcome Measure Information:
Title
composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy
Time Frame
12 months after the last subject accepts vitrectomy
Secondary Outcome Measure Information:
Title
the change of Best-corrected visual acuity
Time Frame
the change of best-corrected visual acuity at month 12 after vitrectomy
Title
the change of inflammatory factors in vitreous body
Description
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
Time Frame
7 days after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SUYAN LI, Doctor
Phone
+86-13852101175
Email
lisuyan1226@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
JUNYAN ZHANG, bachelor
Phone
+86-13701739364
Email
richard.zhang@both-win.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SUYAN LI, doctor
Organizational Affiliation
Ophthalmology Department of the 1st People Hospital of Xuzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First People Hospital of Xuzhou
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suyan Li, Doctor
Phone
+86-13852101775
Email
lisuyan1226@126.com
First Name & Middle Initial & Last Name & Degree
Junyan Zhang, Bachelor
Phone
+86-13701739364
Email
richard.zhang@both-win.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20332654
Citation
Guthoff R, Riederle H, Meinhardt B, Goebel W. Subclinical choroidal detachment at sclerotomy sites after 23-gauge vitrectomy: analysis by anterior segment optical coherence tomography. Ophthalmologica. 2010;224(5):301-7. doi: 10.1159/000298750. Epub 2010 Mar 23.
Results Reference
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PubMed Identifier
22737351
Citation
Dehghan MH, Salehipour M, Naghib J, Babaeian M, Karimi S, Yaseri M. Pars plana vitrectomy with internal limiting membrane peeling for refractory diffuse diabetic macular edema. J Ophthalmic Vis Res. 2010 Jul;5(3):162-7.
Results Reference
background
PubMed Identifier
22848140
Citation
Cho M, D'Amico DJ. Transconjunctival 25-gauge pars plana vitrectomy and internal limiting membrane peeling for chronic macular edema. Clin Ophthalmol. 2012;6:981-9. doi: 10.2147/OPTH.S33391. Epub 2012 Jul 6.
Results Reference
background
PubMed Identifier
17804919
Citation
Song SJ, Sohn JH, Park KH. Evaluation of the efficacy of vitrectomy for persistent diabetic macular edema and associated factors predicting outcome. Korean J Ophthalmol. 2007 Sep;21(3):146-50. doi: 10.3341/kjo.2007.21.3.146.
Results Reference
background
PubMed Identifier
24339677
Citation
Gupta V, Arevalo JF. Surgical management of diabetic retinopathy. Middle East Afr J Ophthalmol. 2013 Oct-Dec;20(4):283-92. doi: 10.4103/0974-9233.120003.
Results Reference
background
PubMed Identifier
24379924
Citation
Shamsi HN, Masaud JS, Ghazi NG. Diabetic macular edema: New promising therapies. World J Diabetes. 2013 Dec 15;4(6):324-38. doi: 10.4239/wjd.v4.i6.324.
Results Reference
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PubMed Identifier
21860693
Citation
Romero-Aroca P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes. 2011 Jun 15;2(6):98-104. doi: 10.4239/wjd.v2.i6.98.
Results Reference
background
PubMed Identifier
22737347
Citation
Bainbridge J. Refractory diabetic macular edema. J Ophthalmic Vis Res. 2010 Jul;5(3):143-4. No abstract available.
Results Reference
background
PubMed Identifier
15564755
Citation
Jahn CE, Topfner von Schutz K, Richter J, Boller J, Kron M. Improvement of visual acuity in eyes with diabetic macular edema after treatment with pars plana vitrectomy. Ophthalmologica. 2004 Nov-Dec;218(6):378-84. doi: 10.1159/000080940.
Results Reference
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PubMed Identifier
20572497
Citation
Robaszkiewicz J, Chmielewska K, Wierzbowska J, Figurska M, Frontczak-Baniewicz M, Stankiewicz A. [Combined surgical and pharmacological treatment of diabetic maculopathy]. Klin Oczna. 2010;112(1-3):19-23. Polish.
Results Reference
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25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China

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