At Gyroscope Therapeutics, our ultimate goal for our patients is Vision for Life
Our clinical development programme is built on the discoveries of our founders and research scientists related to the role of immune response in dry age-related macular degeneration (AMD).
We are working with some of the world’s leading gene therapy and retina experts to evaluate if our investigational gene therapy, GT005, can slow the progression of dry AMD that can lead to blindness. We are also conducting broad population-based studies to learn more about genetics and the progression of dry AMD.
GT005 is an investigational, adeno-associated virus-based (AAV) gene therapy, designed as a one-time treatment that is delivered under the retina and is intended to slow the progression of geographic atrophy (GA) secondary to AMD.
FOCUS is a Phase I/II clinical trial evaluating the safety and dose response of GT005 in people with GA secondary to AMD.
Status: Enrollment Complete
Learn More about FOCUS
FOCUS [NCT03846193] is an open-label Phase I/II clinical trial evaluating the safety and dose response of three doses of GT005 given as a single subretinal injection. FOCUS enrolled 56 people who have a clinical diagnosis of GA secondary to AMD who will be followed initially for 48 weeks.
The FOCUS study enrolled participants at a number of centres in the United Kingdom and United States. Locations can be found at ClinicalTrials.gov.
Who can participate?
FOCUS was open to adults aged 55 years and older with a diagnosis of GA in both eyes secondary to AMD. Specific eligibility criteria and exclusions can be found at ClinicalTrials.gov.
HORIZON is a Phase II clinical trial that is studying the safety and effectiveness of GT005 in people who have GA secondary to AMD.
Status: Enrollment Complete
Learn More about HORIZON
HORIZON [NCT04566445] is a randomised Phase II clinical trial evaluating the safety and effectiveness of two doses of GT005 administered as a one time single subretinal injection procedure.
HORIZON enrolled approximately 250 people who had a clinical diagnosis of GA, secondary to AMD. Participants in HORIZON were assigned to one of two treatment arms or the control arm of the trial for a 96 week follow up.
HORIZON enrolled participants at sites based in the United Kingdom, United States, mainland Europe and Australia. A current list of trial sites can be found at ClinicalTrials.gov.
Who participated?
HORIZON was open to adults aged 55 and older who have been diagnosed with GA secondary to AMD. Specific eligibility criteria and exclusions can be found at ClinicalTrials.gov.
EXPLORE is a Phase II clinical trial that is studying the safety and effectiveness of GT005 in people with GA secondary to AMD who have rare variants in their Complement Factor I (CFI) gene associated with low levels of the Factor I (FI) protein in their blood.
Status: Currently Enrolling
Learn More about EXPLORE
EXPLORE [NCT04437368] is a randomised Phase II clinical trial evaluating the safety and effectiveness of two doses of GT005 administered as a one-time subretinal injection procedure. EXPLORE is enrolling up to 75 people who have GA secondary to AMD who have rare variants in their CFI gene associated with low levels of the FI protein in their blood. Participants in EXPLORE may be assigned to one of two treatments arm or the control arm of the trial and will be followed for 96 weeks.
People being screened for the trial will be genotyped for CFI variants through a blood or saliva sample. If they do not have the specific variants being studied in EXPLORE, they may be eligible for participation in other GT005 trials.
EXPLORE is enrolling participants at sites based in the United Kingdom, United States, mainland Europe and Australia. A current list of trial sites can be found at ClinicalTrials.gov.
Who can participate?
EXPLORE is open to adults aged 55 and older who have been diagnosed with GA secondary to AMD, have rare variants in their CFI gene associated with low levels of the FI protein in their blood. Specific eligibility criteria and exclusions can be found at ClinicalTrials.gov.
To request more information about participating in one of our clinical trials contact us here.
TELESCOPE is a genetic screening study designed to identify people with GA, secondary to AMD. In the study, a person’s genetic profile is determined through a process called ‘genotyping’ using saliva samples provided by the trial participants.
Status: Enrollment is now completed in the main study and substudy
Learn More about TELESCOPE
Genotyping is a process whereby a person’s DNA is evaluated using biological tests to determine differences in their genetic makeup, when compared to other individuals. A certain genetic makeup might indicate predisposition to a disease like dry AMD.
The results of the saliva test may qualify participants for enrollment into one of Gyroscope’s ongoing trials evaluating a gene therapy for GA.
Who can participate?
TELESCOPE eligibility included those with GA due to AMD in one or both eyes, have no history or evidence of bilateral wet AMD in both eyes and are 55 years old or older.
Enrollment for the TELESCOPE is now completed in the United States, Australia, Spain, Ireland and the UK.
SCOPE is an observational study that evaluates how certain genes may lead to the development of AMD and how it naturally progresses. This type of study is “observational” because no treatments are tested, and findings will be used to help inform trials and develop new medicines for dry AMD.
Status: Enrollment Complete
Learn More about SCOPE
SCOPE [NCT03894020] is an observational study that is evaluating how dry AMD progresses in people with certain genetic profiles. Candidates are screened through a process called genotyping using saliva samples provided by the potential candidates. Genotyping is a process where a person’s DNA is evaluated using biological tests to determine differences in a person’s genetic code that might indicate a predisposition to a disease like dry AMD.
Study participants may be followed for up to 96 weeks, or may be invited to participate in one of Gyroscope’s clinical trials evaluating its investigational gene therapy, GT005, if eligible.
By genotyping people with this diagnosis, we will generate a valuable dataset to inform genetic, biomarker, and progression data for future development.
The SCOPE study enrolled participants at a number of major retinal health centres in the United Kingdom, United States, mainland Europe and Australia. A full list of locations and status can be found at ClinicalTrials.gov.
ORACLE is a long-term follow-up study for people previously treated with investigational gene therapy GT005 in either EXPLORE or HORIZON.
Status: Enrollment is by invitation only
Learn More about ORACLE
ORACLE [NCT03894020] is a long-term follow-up study evaluating the safety and durability of GT005 in participants with Geographic Atrophy (GA) secondary to AMD who have been treated in the previous Gyroscope Phase II clinical studies (EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445).
No further investigational product will be administered within this study, and all participants will be invited to enter ORACLE upon their completion of EXPLORE or HORIZON. This study will consist of visits over a three-year period (a total follow-up period of five-years post-GT005 administration).
Who can participate?
The ORACLE study is open to adults aged 55 and older who have been diagnosed with GA secondary to AMD and that have previously participated in EXPLORE or HORIZON. Specific eligibility criteria and exclusions can be found at ClinicalTrials.gov.
