B/BE/25/BVW7 - Information sheet for the public (prepared by the notifier)Public information according to the provisions of Directive 2001/18/EC
Long title
A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBVRGX-314) in a Real-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)
Date receipt dossier
EU record number
B/BE/25/BVW7
EudraCT number
CT 2024-512298-28-00
Company / Sponsor
AbbVie Deutschland GmbH & Co. KG
Phase
IIIb
Treated organism
Humans
Indication category
Eye degenerative disease
Disease
Neovascular Age-Related Macular Degeneration (nAMD)
Therapeutic approach
Gene therapy
Genetic modification
Non-replicating recombinant vector derived from adeno-associated virus AAV8 carrying the human anti-vascular endothelial growth factor (VEGF) antigen-binding fragment.
Method of transfer of nucleic acid of interest
Non-replicating recombinant vector derived from adeno-associated virus AAV8
Administered biological material
Genetically modified virus
Route of administration
Subretinal
Locations in Belgium
UZ Ghent and UZ Leuven
Nr of subjects
Up to 561 patients overall and 4 patients in Belgium
Foreseen duration
From 05Feb2026 till 06Apr2033
Type of procedure
Contained use and Deliberate release
Current status
Authorized