drugset / Trial / NCT01024998
Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This Phase 1 clinical research study will examine the safety and tolerability of an experimental gene transfer agent, AAV2-sFLT01, in patients with Neovascular Age-Related Macular Degeneration (AMD).
Timeline
- Start
- 2010-01-11
- Primary completion
- 2014-07
- Completion
- 2018-07
Publications
- Wazan LE, Widhibrata A, Liu GS. Soluble FLT-1 in angiogenesis: pathophysiological roles and therapeutic implications. Angiogenesis. 2024 Nov;27(4):641-661. doi: 10.1007/s10456-024-09942-8. Epub 2024 Aug 29.
- Heier JS, Kherani S, Desai S, Dugel P, Kaushal S, Cheng SH, Delacono C, Purvis A, Richards S, Le-Halpere A, Connelly J, Wadsworth SC, Varona R, Buggage R, Scaria A, Campochiaro PA. Intravitreous injection of AAV2-sFLT01 in patients with advanced neovascular age-related macular degeneration: a phase 1, open-label trial. Lancet. 2017 Jul 1;390(10089):50-61. doi: 10.1016/S0140-6736(17)30979-0. Epub 2017 May 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AAV2-sFLT01 | Gene therapy (AAV / viral vector) | 2e+08 vg | Intravitreal |
| Subject | AAV2-sFLT01 | Gene therapy (AAV / viral vector) | 2e+09 vg | Intravitreal |
| Subject | AAV2-sFLT01 | Gene therapy (AAV / viral vector) | 6e+09 vg | Intravitreal |
| Subject | AAV2-sFLT01 | Gene therapy (AAV / viral vector) | 2e+10 vg | Intravitreal |