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 De

Study 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 De
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: 
17 Mar 2023
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

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