The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SPVN20 for the treatment of rod-cone dystrophy. The public consultation will take place from 19 May to 18 June 2025.
For each clinical trial application for the use of a genetically modified organism, the government organises a 30-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.
Rod-cone dystrophy is an eye disease, also known as retinitis pigmentosa, in patients with dormant cones. Dormant cones are living photoreceptor cells in the retina that can no longer respond to light because their light-sensitive segment has broken down. When these segments break down, it can lead to complete blindness.
In this clinical trial, SPVN20, a gene therapy that compensates for a genetic variant, will be administered. This involves inserting therapeutic human genes to repair or improve malfunctioning cells. The gene encoding the G protein-gated inwardly rectifying potassium (GIRK) channel is injected into the eye, with the expectation that the dormant cones will respond to light again.
The investigational medicinal product SPVN20 is administered by intravitreal injection, a routine procedure performed by ophthalmologists under local anaesthesia. This involves injecting an solution into the vitreous (the gel-like fluid in the eye) with a syringe and a thin sterile needle.
The aim of the trial is to assess the safety of SPVN20 in treating patients with no light perception due to rod-cone dystrophy. Specifically, it will evaluate whether SPVN20 causes side effects and determine which doses are safe for humans.
The clinical trial will take place at the University Hospital in Ghent.
How to give your opinion?
The public consultation runs from 19 May to 18 June 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.