drugset / Trial / NCT02447185
25-G Vitrectomy With Ranibizumab or Triamcinolone Acetonide on PDR in China-Randomized Clinical Trial
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2015-06
- Primary completion
- 2020-12
- Completion
- 2021-12
Publications
- Results 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 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 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 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 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 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 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 Bainbridge J. Refractory diabetic macular edema. J Ophthalmic Vis Res. 2010 Jul;5(3):143-4. No abstract available.
- Results 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 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.2 mg | Intravitreal |
| Subject | Triamcinolone Acetonide | Other / unclassified | 1 mg | Intravitreal |