The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine surabgene lomparvovec (ABBV-RGX-314) for the treatment of neovascular age-related macular degeneration. The public consultation will take place from 15 October to 14 November 2025.
For each clinical trial application for the use of a genetically modified organism, the government organises a thirty-day public consultation, in accordance with the Royal Decree of 21 February 2005. As a citizen, you can give your opinion on this clinical trial application with a genetically modified medicine.
Neovascular age-related macular degeneration (nAMD) is the abnormal growth of new blood vessels in the retina located at the back of the eye. These new blood vessels can damage the macula which is the part of the retina that enables sharp, clear vision. This damage can block vision in the centre of the eye and cause permanent vision loss. The current treatment for nAMD includes a group of medicines called anti-vascular endothelial growth factor (anti-VEGF) which need many injections and many trips to the doctor’s office.
In this clinical trial, the investigated medicine surabgene lomparvovec (ABBV-RGX-314) will be administered through a single subretinal injection compared to intravitreal injections of ranibizumab, an anti-VEGF treatment already authorised in European Union for nAMD patients. ABBV-RGX-314 is a gene therapy that allows production of an anti-VEGF protein to slow the growth of new blood vessels that impair vision. It works in a similar way as current anti-VEGFs but has the potential to have a more lasting effect than current treatments.
The aim of this trial is to assess the safety and long-term efficacity of surabgene lomparvovec (ABBV-RGX-314) in patients 50 years of age and older, diagnosed with nAMD.
The clinical trial will take place at the University Hospital in Leuven and at the University Hospital in Ghent.
How to give your opinion?
The public consultation runs from 15 October to 14 November 2025 inclusive. You can access the various data in the application file, as well as an online form to send your comments or ask your questions.
General information on GMO - public consultation.