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

• ClinicalTrials.gov Identifier: NCT02447185
• Recruitment Status: Recruiting
• First Posted: May 18, 2015
• Last Update Posted: September 24, 2018
• 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: May 14, 2015
• First Posted Date: May 18, 2015
• Last Update Posted Date: September 24, 2018
• Study Start Date: June 2015
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 15, 2015): intraoperative bleeding [ Time Frame: during operation of 25-G Vitrectomy ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02447185 on ClinicalTrials.gov Archive Site

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

Descriptive Information

• Brief Title: 25-G Vitrectomy With Ranibizumab or Triamcinolone Acetonide on PDR in China-Randomized Clinical Trial
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• 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 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

• 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 *

• 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.
• 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. Review.
• 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. Review.
• 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.
• Jahn CE, Töpfner 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.
• 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. Review. Polish.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 15, 2015): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2020 (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

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: SUYAN LI, MD; +86-13852101175; lisuyan1226@126.com

Contact: XINTING WANG, Med Master; +86-15950664745; xintinghappy1017@sina.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02447185
• Other Study ID Numbers: PDR-RAN-RCT-LSY
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: JUNYAN ZHANG, The First People's Hospital of Xuzhou
• Study Sponsor: JUNYAN ZHANG
• Collaborators: The First People's Hospital of Xuzhou

Investigators

• 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