drugset / Trial / NCT06022744
An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With nAMD
Not yet recruiting
12 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NaSingle-groupOpen-labelTreatment
Summary
To evaluate the safety and tolerability of intravitreal injection of LX109 in patients with nAMD.
Timeline
- Start
- 2023-09-01
- Primary completion
- 2025-09-30
- Completion
- 2027-09-30
Publications
- Background Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.
- Background Yang K, Liang YB, Gao LQ, Peng Y, Shen R, Duan XR, Friedman DS, Sun LP, Mitchell P, Wang NL, Wong TY, Wang JJ. Prevalence of age-related macular degeneration in a rural Chinese population: the Handan Eye Study. Ophthalmology. 2011 Jul;118(7):1395-401. doi: 10.1016/j.ophtha.2010.12.030. Epub 2011 Mar 27.
- Background Ye H, Zhang Q, Liu X, Cai X, Yu W, Yu S, Wang T, Lu W, Li X, Jin H, Hu Y, Kang X, Zhao P. Prevalence of age-related macular degeneration in an elderly urban chinese population in China: the Jiangning Eye Study. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6374-80. doi: 10.1167/iovs.14-14899.
- Background van Lookeren Campagne M, LeCouter J, Yaspan BL, Ye W. Mechanisms of age-related macular degeneration and therapeutic opportunities. J Pathol. 2014 Jan;232(2):151-64. doi: 10.1002/path.4266.
- Background Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. Lancet. 2018 Sep 29;392(10153):1147-1159. doi: 10.1016/S0140-6736(18)31550-2.
- Background Khandhadia S, Cherry J, Lotery AJ. Age-related macular degeneration. Adv Exp Med Biol. 2012;724:15-36. doi: 10.1007/978-1-4614-0653-2_2.
- Background Fleckenstein M, Keenan TDL, Guymer RH, Chakravarthy U, Schmitz-Valckenberg S, Klaver CC, Wong WT, Chew EY. Age-related macular degeneration. Nat Rev Dis Primers. 2021 May 6;7(1):31. doi: 10.1038/s41572-021-00265-2.
- Background Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5.
- Background Cabral T, Lima LH, Mello LGM, Polido J, Correa EP, Oshima A, Duong J, Serracarbassa P, Regatieri CV, Mahajan VB, Belfort R Jr. Bevacizumab Injection in Patients with Neovascular Age-Related Macular Degeneration Increases Angiogenic Biomarkers. Ophthalmol Retina. 2018 Jan;2(1):31-37. doi: 10.1016/j.oret.2017.04.004.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LX109 | Gene therapy (AAV / viral vector) | 7e+09 vg | Intravitreal |
| Subject | LX109 | Gene therapy (AAV / viral vector) | 3.5e+10 vg | Intravitreal |
Indications
No indication recorded.