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

• ClinicalTrials.gov Identifier: NCT02328118
• Recruitment Status: Unknown
• First Posted: December 31, 2014
• Last Update Posted: August 25, 2016
• Sponsor: JUNYAN ZHANG
• 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: December 20, 2014
• First Posted Date: December 31, 2014
• Last Update Posted Date: August 25, 2016
• Study Start Date: February 2015
• Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 26, 2014): composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy [ Time Frame: 12 months after the last subject accepts vitrectomy ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 26, 2014)

• 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 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China
• Official Title: 25-Gauge Vitrectomy Combine With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in Chinese Patients
• 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.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Proliferative Diabetic Retinopathy

Intervention

• 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:

  • Vitreal S
  • Cinonide
  • Tricort 40
  • Kenalog

Study Arms

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

  • Drug: Ranibizumab
  • Drug: Triamcinolone Acetonide
• Experimental: Triamcinolone Acetonide 4mg
  All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
  Intervention: Drug: Triamcinolone Acetonide

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Bainbridge J. Refractory diabetic macular edema. J Ophthalmic Vis Res. 2010 Jul;5(3):143-4. No abstract available.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 26, 2014): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2017
• Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02328118
• Other Study ID Numbers: PDR-RAN-LSY
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: JUNYAN ZHANG, The First People's Hospital of Xuzhou
• Original Responsible Party: Same as current
• Current Study Sponsor: JUNYAN ZHANG
• Original Study Sponsor: Same as current
• Collaborators: The First People's Hospital of Xuzhou

Investigators

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

• PRS Account: The First People's Hospital of Xuzhou
• Verification Date: August 2016