ORACLE
Research type
Research Study
Full title
ORACLE: A long-term follow-up study to evaluate the safety and durability of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study.
IRAS ID
1007399
Contact name
Kate Parsley
Contact email
Sponsor organisation
Gyroscope Therapeutics Ltd.
Eudract number
2020-003987-22
Research summary
This is a prospective multi-centre, long-term, follow-up study for study participants who received a single dose of GT005 in a previous clinical trial (GT005-02 EXPLORE or GT003-05 HORIZON). No further investigational therapy will be administered during this clinical trial. Patients will be invited to participate in the GT-ORACLE study upon completion of their participation in one of the previous clinical trials named above.
The overall objectives of the study are to evaluate the long-term safety and durability of GT005 in participants with GA secondary to AMD who have been treated in an antecedent study.Following consent, patients be invited to attend the following study visits:
Visit 1 (will coincide with the final visit of antecedent study),
Visit 2 (2.4 years post-GT005 administration),
Visit 3 (3 years post-GT005 administration),
Telephone call 1 (3.5 years post- GT005 administration),
Visit 4 (4 years post-GT005 administration),
Telephone call 2 (4.5 years post-GT005 administration),
Visit 5 (5 years post-GT005 administration).
Timing of study visits is determined according to the date of GT005 administration in the previous study. Patients will be in the GT-ORACLE study for approximately 3 years.
During study visits, patient will undergo the following ophthalmic tests in both eyes: Standard Ophthalmic Examination, Visual Function Assessments (Best Corrected Visual Acuity with ETDRS, Low Luminance Visual Acuity with ETDRS for Low Luminance Difference, Functional Reading Independence Index), Colour Fundus Photography, Fundus Autofluorescence, Optical Coherence Tomography, Microperimetry, Best Corrected Visual Acuity and Low Luminance Deficit. Other study activities include AE/ SAE monitoring and review of participants' concomitant medications. Patients will be also asked to complete, or to provide responses to, study questionnaires on how their vision affects their everyday reading, health and ability to conduct their day-to-day activities.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0209
Date of REC Opinion
4 Sep 2023
REC opinion
Further Information Favourable Opinion