Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Phase II, outcomes, assessor-masked multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related to macular degeneration

Proposed period of release:
01/03/2020 to 31/07/2021

Name of the Institute(s) or Company(ies)
Gyroscope Therapeutics Limited, ;

3. Is the same GMO release planned elsewhere in the Community?
Germany; France; United Kingdom; Netherlands;

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependovirus
Species: AAV-derived replication-deficient viral vector

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2DependoparvovirusAdeno-associated Virus--Serotype 2

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known