Calendario›RGNX›RGX-314
RGX-314
Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial
Ensayo de REGENXBIO Inc. en Neovascular Age-related Macular Degeneration · Wet Age-related Macular Degeneration (del registro, en inglés).
Más ensayos de: Degeneración macular asociada a la edad neovascular.
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 42
- Centros
- 8
- Fin del objetivo primario
- nov 2019
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2017.
Qué mide
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)) (26 weeks (24 weeks following RGX-314 administration)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroExcessive vascular endothelial growth factor (VEGF) plays a key part in promoting neovascularization and edema in neovascular (wet) age-related macular degeneration (nAMD). VEGF inhibitors (anti-VEGF), including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron), have been shown to be safe and effective for treating nAMD and have demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via intravitreal injection and can be a significant burden to the patients. RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment burden of currently available therapies while maintaining vision with a favorable benefit:risk profile.
Más ensayos de RGNX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| RGX-121 | Fase 2/3 | En marcha, sin reclutar | nov 2023 (real) |
| AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD | no aplica | En marcha, sin reclutar | jun 2026 (real) |
| RGX-202 | Fase 2/3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Long Term Follow-Up for RGX-111 | no aplica | Reclutando por invitación | sep 2027 (prevista) |
| RGX-121-3102 | Fase 3 | En marcha, sin reclutar | abr 2028 (prevista) |
| Long-term Follow-Up for RGX-121 | no aplica | En marcha, sin reclutar | oct 2028 (prevista) |
Todos los de RGNX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03066258), actualizada en may 2023.