ORACLE: A long-term follow-up study to evaluate the safety of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study. (ORACLE)

Research summary

GT005, a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding for human complement factor I, is currently being developed as a potential gene therapy for GA secondary to AMD. Current regulatory guidelines [EMA 2009; EMA 2018; FDA 2020] recommend that participants enrolled in gene therapy clinical trials with viral vectors that are non-replicating, non-integrating, and have no known potential for latency and re-activation should be followed for approximately 5 years post-treatment. The aim of this study (GT-ORACLE) is to evaluate the long-term safety and durability of GT005 for up to 5 years post-treatment. All participants treated with GT005 in the GT005-02 (EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445) study will be invited to enrol in this long-term, follow-up study.

Principal Investigator

Mr Kanmin Xue

Contact us

Email: ERGO@ouh.nhs.uk

IRAS number

1007399