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Notification report


Full notification file


General information

Notification Number
B/ES/20/13

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
17/08/2020

Title of the Project
A Phase II, open-label, outcomes-assessor masked, multicentre, randomised, controlled 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 dry age related macular degeneration.

Proposed period of release:
01/12/2020 to 30/11/2022

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


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

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

If yes, notification number(s):
B/DE/20/PEI3944; B/ES/19/24; B/NL/19/024;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Parvoviridae
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