Clinical Trials

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, one-time adeno-associated virus-based (AAV) gene therapy that is delivered under the retina and is intended to slow the progression of geographic atrophy (GA) secondary to dry AMD.

To request more information about participating in one of our clinical trials contact us here.

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: Currently Enrolling

Learn More about SCOPE

SCOPE [NCT03894020is 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.

Our goal is to genotype more than 6,000 people with a diagnosis of GA secondary to dry AMD and enrol approximately 350 people into SCOPE. 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 is enrolling participants at a number of major retinal health centres in the United Kingdom, United States, Spain, France, Germany, the Netherlands and Australia. A full list of locations and status can be found at ClinicalTrials.gov.

 Who can participate?

SCOPE is open to adults 18 years and older with a diagnosis of GA in one or both eyes secondary to dry AMD. 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.

FOCUS is a Phase I/II clinical trial evaluating the safety and dose response of GT005 in people with GA secondary to dry AMD.

Status: Currently Enrolling

Learn More about FOCUS

FOCUS [NCT03846193is 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 is enrolling approximately 45 people who have a clinical diagnosis of GA secondary to dry AMD who will be followed initially for 48 weeks.

The FOCUS study is enrolling participants at a number of centres in the United Kingdom and United States. Locations can be found at ClinicalTrials.gov.

Who can participate?
FOCUS is open to adults aged 55 years and older with a diagnosis of GA in both eyes secondary to dry AMD. 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.

EXPLORE is a Phase II clinical trial that is studying the safety and effectiveness of GT005 in people with GA secondary to dry AMD who have rare variants in their Complement Factor I (CFI) gene and who have low levels of the CFI 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 single subretinal injection. EXPLORE is enrolling approximately 75 people who have GA secondary to dry AMD who have rare variants in their Complement Factor I (CFI) gene and low levels of the CFI 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 48 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, 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 dry AMD, have rare variants in their CFI gene and have low levels of the CFI 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.

HORIZON is a Phase II clinical trial that is studying the safety and effectiveness of GT005 in people who have GA secondary to dry AMD. HORIZON is evaluating GT005 in a broader group of people with dry AMD than EXPLORE.

Status: Currently Enrolling

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 single subretinal injection. HORIZON is enrolling 180 people who have GA secondary to dry AMD. Participants in HORIZON may be assigned to one of two treatment arms or the control arm of the trial and will be followed for 48 weeks.

People being screened for the trial will be genotyped through a blood or saliva sample as part of Gyroscope’s overall genotyping initiative.

HORIZON is enrolling participants at sites based in the United Kingdom, United States, Europe and Australia. A current list of trial sties can be found at ClinicalTrials.gov.

Who can participate?

HORIZON is open to adults aged 55 and older who have been diagnosed with GA secondary to dry AMD. 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.

Gyroscope Therapeutics policy on expanded access to investigational therapies

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If you or a family member and would like more information about our clinical trials, and to see if you meet the criteria to participate, please contact us here.

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