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| Name | Class |
|---|---|
| The First People's Hospital of Xuzhou | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5 mg | Experimental | All subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection. |
|
| Triamcinolone Acetonide 4mg | Experimental | All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy | 12 months after the last subject accepts vitrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| the change of Best-corrected visual acuity | the change of best-corrected visual acuity at month 12 after vitrectomy | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SUYAN LI, Doctor | Contact | +86-13852101175 | lisuyan1226@126.com | |
| JUNYAN ZHANG, bachelor | Contact | +86-13701739364 | richard.zhang@both-win.net |
| Name | Affiliation | Role |
|---|---|---|
| SUYAN LI, doctor | Ophthalmology Department of the 1st People Hospital of Xuzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People Hospital of Xuzhou | Recruiting | Xuzhou | Jiangsu | 221002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20332654 | Background | 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. | |
| 22737351 | Background | 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. |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Triamcinolone Acetonide | Drug | 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. |
|
|
| 7 days after injection |
| 22848140 | Background | 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. |
| 17804919 | Background | 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. |
| 24339677 | Background | 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. |
| 24379924 | Background | 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. |
| 21860693 | Background | 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. |
| 22737347 | Background | Bainbridge J. Refractory diabetic macular edema. J Ophthalmic Vis Res. 2010 Jul;5(3):143-4. No abstract available. |
| 15564755 | Background | 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. |
| 20572497 | Background | 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. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |