25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China
NCT ID: NCT02328118
Last Updated: 2016-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2015-02-28
2017-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ranibizumab 0.5 mg
All subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection.
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.
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.
Triamcinolone Acetonide 4mg
All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Vitreous hemorrhage/Proliferation of retinal/Tractional detachment of retina
* Fasting blood-glucose no more than 8mmol/ml
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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The First People's Hospital of Xuzhou
OTHER
JUNYAN ZHANG
OTHER
Responsible Party
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JUNYAN ZHANG
Senior Consultant and Statistician
Principal Investigators
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SUYAN LI, doctor
Role: PRINCIPAL_INVESTIGATOR
Ophthalmology Department of the 1st People Hospital of Xuzhou
Locations
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The First People Hospital of Xuzhou
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PDR-RAN-LSY
Identifier Type: -
Identifier Source: org_study_id
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