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 mrt 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
Information for the public
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Public information according to the provisions of Directive 2001/18/EC
Information related to the decision procedure
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15 June 2023 - The Biosafety Advisory Council issues a positive advice (with conditions) for this deliberate release
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10 July 2023: The Federal Ministers give a final decision (positive with conditions) for this trial