PMS Registry
Company Name
Novartis
Protocol Number
CLTW888A12401
Title of Study
A Post-Authorization, Multicenter, Multinational, Longitudinal, Observational Safety Registry Study for Patients Treated with Voretigene Neparvovec
Primary Objective
The objective of this registry-based study is to collect long-term safety information (i.e., for 5 years after treatment) associated with voretigene neparvovec (vector and/or transgene), its subretinal injection procedure, the concomitant use of corticosteroids, or a combination of these procedures and products.
Number of Sites
1
Period of Study
From:01/Mar/2024 to:30/Jun/2030
Number of Patients
40人
IRB Approval Date
Publication Plan / Date
NA