A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT)
AbbVie Deutschland GmbH & Co. KG
Age-related macular degeneration (AMD) affects the macula, which is needed for sharp, clear vision.
There are 2 types of AMD: wet and dry.
“Wet” AMD is less common, it is more severe.
In wet AMD, new, abnormal blood vessels form and cause fluid to build up in the retinal tissue. This is caused by the eye releasing a protein called vascular endothelial growth factor (VEGF). These new blood vessels and fluid cause damage to the macula that can be slow, but it can also result in rapid vision loss. The fluid in the retina can damage and eventually irreversibly destroy the cells of the eye responsible for vision. Therefore, early treatment of wet AMD is important, and limiting the effects of VEGF can improve the symptoms of wet AMD.
This study will use an investigational drug called ABBV-RGX-314 (also known as RGX 314) which is being developed for the treatment of AMD, as well as other retinal diseases. ABBV-RGX-314 contains a gene that tells the cells to make a protein that blocks VEGF in the eye and stops fluid from building up, which may help recover lost vision and stop new vision loss.
The standard treatment for wet AMD is monthly or bi-monthly injections into the back of the eye. ABBV-RGX-314 is being studied for its potential to have one single injection that could allow the eye to make its own supply of anti-VEGF continually. This may decrease the need for future treatment for wet AMD and help stop further vision loss.
It is planned to enroll approximately 660 participants globally across 160 sites.
Participants will be on the study for between 60 to 114 weeks.
AbbVie Deutschland GmbH & Co is the Sponsor of this study.
North East - York Research Ethics Committee
Date of REC Opinion
27 Oct 2023
Further Information Favourable Opinion