B/BE/25/BVW4 - Information sheet for the public (prepared by the notifier)Public information according to the provisions of Directive 2001/18/EC
Long title
An Open-Label Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravitreal Injection of SPVN20 Gene Therapy in Subjects with No Light Perception Due to End-Stage Rod-Cone Dystrophy, and Who Retain Dormant Foveal Cone Photoreceptors (NYRVANA)
Date receipt dossier
EU record number
B/BE/25/BVW4
EudraCT number
2025-520665-47-00
Company / Sponsor
SparingVision
Phase
I
Treated organism
Humans
Indication category
Eye degenerative disease
Disease
End-stage rod-cone dystrophy
Therapeutic approach
Immunotherapy
Genetic modification
Non-replicating recombinant vector derived from adeno-associated virus AAV2 carrying the G protein-gated inwardly rectifying potassium (GIRK) channel 1, mutated for an F137S amino-acid substitution (GIRK1(F137S)) gene
Method of transfer of nucleic acid of interest
Non-replicating recombinant vector derived from adeno-associated virus AAV2
Administered biological material
Genetically modified virus
Route of administration
Intravitreal
Locations in Belgium
UZ Gent
Nr of subjects
Up to 9 patients overall and 4 patients in Belgium
Foreseen duration
From July 2025 to July 2031 in Belgium
Type of procedure
Contained use and Deliberate release
Current status
Authorized