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-Relate

Study 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-Relate
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: 
10 oct 2025
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: 
Under evaluation

Information for the public