drugset / Trial / NCT03675880
TAB014(Drug Code) in Wet( Neovascular)Age-related Macular Degeneration(AMD) Subjects
RandomizedParallel-groupOpen-labelTreatment
Summary
Subjects with secondary wet age-related macular degeneration(AMD) or recurrent subfoveal choroidal neovascularization (CNV) in only one study eye will be enrolled into the study.
Timeline
- Start
- 2018-06-15
- Primary completion
- 2019-02-15
- Completion
- 2019-04-30
Publications
- Results Schouten JS, La Heij EC, Webers CA, Lundqvist IJ, Hendrikse F. A systematic review on the effect of bevacizumab in exudative age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2009 Jan;247(1):1-11. doi: 10.1007/s00417-008-0952-y. Epub 2008 Oct 9.
- Results Jyothi S, Chowdhury H, Elagouz M, Sivaprasad S. Intravitreal bevacizumab (Avastin) for age-related macular degeneration: a critical analysis of literature. Eye (Lond). 2010 May;24(5):816-24. doi: 10.1038/eye.2009.219. Epub 2009 Aug 14.
- Results Mitchell P. A systematic review of the efficacy and safety outcomes of anti-VEGF agents used for treating neovascular age-related macular degeneration: comparison of ranibizumab and bevacizumab. Curr Med Res Opin. 2011 Jul;27(7):1465-75. doi: 10.1185/03007995.2011.585394. Epub 2011 May 31.
- Results Li J, Zhang H, Sun P, Gu F, Liu ZL. Bevacizumab vs ranibizumab for neovascular age-related macular degeneration in Chinese patients. Int J Ophthalmol. 2013 Apr 18;6(2):169-73. doi: 10.3980/j.issn.2222-3959.2013.02.12. Print 2013.
- Results Kodjikian L, Decullier E, Souied EH, Girmens JF, Durand EE, Chapuis FR, Huot L. Bevacizumab and ranibizumab for neovascular age-related macular degeneration: an updated meta-analysis of randomised clinical trials. Graefes Arch Clin Exp Ophthalmol. 2014 Oct;252(10):1529-37. doi: 10.1007/s00417-014-2764-6. Epub 2014 Aug 22.
- Results Manzano RP, Peyman GA, Khan P, Kivilcim M. Testing intravitreal toxicity of bevacizumab (Avastin). Retina. 2006 Mar;26(3):257-61. doi: 10.1097/00006982-200603000-00001.
- Results Feiner L, Barr EE, Shui YB, Holekamp NM, Brantley MA Jr. Safety of intravitreal injection of bevacizumab in rabbit eyes. Retina. 2006 Oct;26(8):882-8. doi: 10.1097/01.iae.0000230717.85319.f5.
- Results Shahar J, Avery RL, Heilweil G, Barak A, Zemel E, Lewis GP, Johnson PT, Fisher SK, Perlman I, Loewenstein A. Electrophysiologic and retinal penetration studies following intravitreal injection of bevacizumab (Avastin). Retina. 2006 Mar;26(3):262-9. doi: 10.1097/00006982-200603000-00002.
- Results Diabetic Retinopathy Clinical Research Network; Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK, Elman MJ, Friedman SM, Greven CM, Maturi RK, Pieramici DJ, Shami M, Singerman LJ, Stockdale CR. A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology. 2007 Oct;114(10):1860-7. doi: 10.1016/j.ophtha.2007.05.062. Epub 2007 Aug 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TAB014 | Monoclonal antibody | 1.25 mg | Intravitreal |
| Subject | TAB014 | Monoclonal antibody | 2 mg | Intravitreal |
| Subject | TAB014 | Monoclonal antibody | 2.5 mg | Intravitreal |
Indications
No indication recorded.