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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.
The screening period was 28 days. The classification of CNV will be determined by Fundus Fluorescein Angiography ( FFA ) at the study centers. Subjects will receive intravitreal injections of TAB014 Monoclonal Antibody Injection in one eye ( the study eye ). Subjects will only receive single intravitreal dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.25mg(0.05ml) single-dose | Experimental | Eight subjects will be treated with TAB014 1.25mg(0.05ml) single-dose |
|
| 2.00mg(0.08ml) single-dose | Experimental | Eight subjects will be treated with TAB014 2.00mg(0.08ml) single-dose |
|
| 2.50mg(0.10ml) single-dose | Experimental | Eight subjects will be treated with TAB014 2.50mg(0.10ml) single-dose |
|
| 1.25mg(0.05ml) multiple-dose | Experimental | Eight subjects will be treated with TAB014 1.25mg(0.05ml) multiple-dose after 1.25mg(0.05ml) single-dose |
|
| 2.00mg(0.08ml) multiple-dose | Experimental | Eight subjects will be treated with TAB014 2.00mg(0.08ml) multiple-dose after 2.00mg(0.08ml) single-dose |
|
| 2.50mg(0.10ml) multiple-dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAB014 | Drug | TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity associated with TAB014 treatment (possibly, probably, or definitively) occurs within 28 days after a single dose of TAB014. | Describe the impairment of vision by examination. | Within 12 weeks after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity and adverse reaction | To Assess the dose-limiting toxicity and adverse reaction of TAB014 Monoclonal Antibody Injection. | Within 12 weeks after administration |
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Inclusion Criteria:
Exclusion Criteria:
1. Prior and concomitant therapy
2. lesion features:
1) Subjects with ongoing any concomitant eye disease(i.e cataracts or diabetic retinopathy) by the investigator's judgment:
Vision loss caused by these diseases to cause interference with medical or operation intervention during 3 months study.
Best corrected visual acuity (BCVA) loss at least of 2 lines Snellen equivalents (ETDRS 10 letters) at 3 months, if don't treat the disease.
2) Subjects who are active endophthalmitis(with micro level or above). 3) Subjects with ongoing internal vitreous hemorrhage. 4) Subjects with Rhegmatogenous retinal detachment or history of macular holes stage 3/4.
5) Subjects with history of idiopathic uveitis or autoimmune uveitis in either eye 6) Subjects with ongoing infectious conjunctivitis, infectious keratitis, infectious scleral or endophthalmitis in either eye.
7) Subjects that have undergone previous intraocular surgery (including cataract surgery ) within the last 3 months before the screening.
8) Subjects who are uncontrolled glaucoma(defined as intraocular pressure [IOP] 30 mmHg, even when treated with anti-glaucoma drugs).
9) Subjects with history of glaucoma filtration surgery. 4. concomitant system disease:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| youxin chen, PHD | Contact | 010-69156699 | chenyouxinpumch@163.com | |
| yan sun, master | Contact | 010-69158355 | xieheyaoli@163.com |
| Name | Affiliation | Role |
|---|---|---|
| youxin chen, PHD | Peking Union Medical College Hospital of Chinese Academy of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital of Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18843500 | Result | 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. | |
| 19680279 | Result | 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. |
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Eight subjects will be treated with TAB014 2.50mg(0.10ml) multiple-dose after 2.50mg(0.10ml) single-dose
|
|
| 21623685 | Result | 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. |
| 23638418 | Result | 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. |
| 25142373 | Result | 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. |
| 16508423 | Result | 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. |
| 17031287 | Result | 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. |
| 16508424 | Result | 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. |
| 17698196 | Result | 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. |