Long-term follow-up study of subretinally administered RGX-314 in participants with nAMD
Research type
Research Study
Full title
A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants with Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy
IRAS ID
1010627
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Clinicaltrials.gov Identifier
Research summary
RGX-314 is a gene therapy being developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterised by loss of vision due to new, leaky blood vessel formation in the retina, caused by the eye releasing a protein called vascular endothelial growth factor (VEGF). Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. The standard treatment for wet AMD is monthly or bi-monthly anti-VEGF injections into the back of the eye.
In the parent study (RGX-314-3101), participants were given a single injection of RGX-314. RGX-314 is being developed as a potential one-time treatment for wet AMD, and 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 purpose of this study is to continue following participants with wet AMD who previously received RGX-314. Participants will be followed for 5 years to look for any long-term safety concerns. There is no treatment provided as part of this study.
During the study participants will undergo eye assessments (which are also performed as part of regular vision care for wet AMD), and procedures (medication reviews, recording of new symptoms/medical problems, and vision questionnaires).
REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0047
Date of REC Opinion
21 Feb 2025
REC opinion
Further Information Favourable Opinion