drugset / Trial / NCT00767949
Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-related Macular Degeneration
NaSingle-groupOpen-labelTreatment
Summary
Age-related macular degeneration (AMD) is a disease that, in time, destroys the macula, which is the central part of the retina that gives sharp central vision. The primary purpose of this study is to assess the safety of iSONEP which is a humanized monoclonal antibody against a bioactive lipid, sphingosine 1-phosphate (S1P).
Timeline
- Start
- 2008-10
- Primary completion
- 2010-07
- Completion
- 2012-08
Publications
- Background Visentin B, Vekich JA, Sibbald BJ, Cavalli AL, Moreno KM, Matteo RG, Garland WA, Lu Y, Yu S, Hall HS, Kundra V, Mills GB, Sabbadini RA. Validation of an anti-sphingosine-1-phosphate antibody as a potential therapeutic in reducing growth, invasion, and angiogenesis in multiple tumor lineages. Cancer Cell. 2006 Mar;9(3):225-38. doi: 10.1016/j.ccr.2006.02.023.
- Background Caballero S, Swaney J, Moreno K, Afzal A, Kielczewski J, Stoller G, Cavalli A, Garland W, Hansen G, Sabbadini R, Grant MB. Anti-sphingosine-1-phosphate monoclonal antibodies inhibit angiogenesis and sub-retinal fibrosis in a murine model of laser-induced choroidal neovascularization. Exp Eye Res. 2009 Mar;88(3):367-77. doi: 10.1016/j.exer.2008.07.012. Epub 2008 Aug 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sonepcizumab | Monoclonal antibody | 0.2 mg | Intravitreal |
| Subject | sonepcizumab | Monoclonal antibody | 0.6 mg | Intravitreal |
| Subject | sonepcizumab | Monoclonal antibody | 1 mg | Intravitreal |
| Subject | sonepcizumab | Monoclonal antibody | 1.4 mg | Intravitreal |
| Subject | sonepcizumab | Monoclonal antibody | 1.8 mg | Intravitreal |