An Open-label, Multicenter, Two Part, Ascending Dose Followed by a Controlled Trial to Assess the Safety and Efficacy of a Subretinal Administration of AAVB-039 in Participants with Stargardt Disease (STGD1) (CELESTE)

Study title: 
An Open-label, Multicenter, Two Part, Ascending Dose Followed by a Controlled Trial to Assess the Safety and Efficacy of a Subretinal Administration of AAVB-039 in Participants with Stargardt Disease (STGD1) (CELESTE)
Long title: 
An Open-label, Multicenter, Two Part, Ascending Dose Followed by a Controlled Trial to Assess the Safety and Efficacy of a Subretinal Administration of AAVB-039 in Participants with Stargardt Disease (STGD1) (CELESTE)
Date receipt dossier: 
23 feb 2026
EU record number: 
B/BE/26/BVW2
EudraCT number: 
2025-522207-15-01
Company / Sponsor: 
AAVantgarde Bio UK Ltd.
Phase: 
I/II
Treated organism: 
Humans
Indication category: 
Eye degenerative disease
Disease: 
Stargardt Disease (STGD1)
Therapeutic approach: 
Gene therapy
Genetic modification: 
Non-replicating recombinant dual vector derived from adeno-associated virus AAV8 carrying functional copies of the ABCA4 gene.
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 Gent
Nr of subjects: 
Up to 15 patients overall and 3 patients in Belgium
Foreseen duration: 
From 19 May 2026 till 29 Oct 2027
Type of procedure: 
Contained use and Deliberate release
Current status: 
Assessed

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