The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicinal product JNJ-81201887 (AAVCAGsCD59) for the treatment of geographic atrophy secondary to age-related macular degeneration. The public consultation runs from 22 March 2023 to 21 April 2023.
For each clinical trial application for the use of a genetically modified organisms, 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 medicinal product.
This clinical trial will investigate the safety and efficacy of JNJ-81201887 (AAVCAGsCD59) for the treatment of patients, 60 years of age or older, with geographic atrophy secondary to age-related macular degeneration (AMD). Geographic atrophy secondary to AMD can lead to severe vision loss and blindness and is currently untreatable. Globally, AMD is thought to be the cause of approximately 9 % of all blindness.
This trial is expected to include 300 patients, including ten patients in Belgium. The medicinal product JNJ-81201887 (AAVCAGsCD59) will be administered to the patients by intravitreal injection (an injection into the vitreous body between the lens and retina of the eye).
The clinical trial will take place between August 2023 and February 2025 at the University Hospital in Ghent, the University Hospital in Leuven, the Centre Hospitalier Universitaire in Liège, the ZNA Middelheim in Antwerp and the Hospital Oost-Limburg in Genk.
How to give your opinion?
The public consultation runs until 21 April 2023 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.