B/BE/23/BVW2 - Information sheet for the public (prepared by the notifier)Public information according to the provisions of Directive 2001/18/EC
Long title
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887(AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Date receipt dossier
EU record number
B/BE/23/BVW2
EudraCT number
2022-500746-16-00
Company / Sponsor
Janssen-Cilag International NV
Phase
IIb
Treated organism
Humans
Indication category
Eye degenerative disease
Disease
Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Therapeutic approach
Gene therapy
Genetic modification
Non-replicating recombinant vector derived from adeno-associated virus AAV2 carrying the soluble human CD59 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, UZ Leuven Gasthuisberg, CHU Liège, ZNA Middelheim (Antwerpen), Ziekenhuis Oost-Limburg (Genk)
Nr of subjects
Up to 300 patients overall and 10 patients in Belgium
Foreseen duration
Between August 2023 – February 2025
Type of procedure
Contained use and Deliberate release
Current status
Authorized