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Gene Therapy
GT005 for Dry Age-Related Macular Degeneration
Phase 1 & 2
Waitlist Available
Research Sponsored by Gyroscope Therapeutics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye (except if the subject is monocular)
Cohorts 1 to 3: the GA lesion in the treatment eye must reside completely within the FAF fundus image
Must not have
Have clinically significant cataract that may require surgery during the study period in the study eye
Have received any investigational product for the treatment of GA within the past 6 months or 5 half-lives (whichever is longer), other than nutritional supplements such as the Age-Related Eye Disease Study (AREDS) formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tested an eye injection treatment called GT005 for people with vision loss from Macular Atrophy due to AMD. The goal was to improve or maintain their vision. The trial was stopped because the treatment was not effective, but it was not due to safety issues.
Who is the study for?
This trial is for adults aged 55+ with Dry Age-Related Macular Degeneration (AMD) causing macular atrophy. Participants must have specific sizes of GA lesions in their eyes and meet certain vision acuity requirements. Women capable of childbearing need a negative pregnancy test, and all participants should be able to attend study visits.
What is being tested?
The FOCUS trial is testing GT005, delivered using the Orbit Subretinal Delivery System, on people with Dry AMD to see if it's safe and effective in treating macular atrophy. It's an open-label Phase I/II multicentre study where everyone receives the treatment.
What are the potential side effects?
Potential side effects are not specified but may include typical risks associated with eye injections such as discomfort, redness, infection risk or changes in vision. As this is a first-in-human study for GT005, close monitoring will occur for any unexpected side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with GA due to AMD in one eye and AMD in the other.
Select...
My eye condition is fully visible in a specific eye test image.
Select...
I can attend all required study visits and complete the procedures.
Select...
I am 55 years old or older.
Select...
I have AMD in both eyes, confirmed by color photos.
Select...
My eye condition affects an area between 1.25mm2 and 17.5mm2.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I might need cataract surgery in the eye being studied during the trial.
Select...
I haven't taken experimental treatments for GA, except for AREDS, in the last 6 months.
Select...
I have undergone gene or cell therapy.
Select...
My eye condition is due to diabetes and is moderate to severe.
Select...
I have had eye surgery or treatment for my retina in the study eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 240 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~240 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of ocular and non-ocular Treatment Emergent AEs (TEAEs) and Treatment-Emergent Serious AEs (TESAEs) Severe Adverse Events (TEAE/TESAE)
Secondary study objectives
Geographic Atrophy
Incidence of device-related AEs and SAEs (US only)
Long-term safety of GT005 at 3 doses
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: GT005 Dose 3 with Orbit Subretinal Delivery SystemExperimental Treatment2 Interventions
A single dose of GT005 will be administered with subretinal injection via suprachoroidal cannulation approach
Group II: GT005 Dose 3 with Orbit Subretinal Delivery SysemExperimental Treatment1 Intervention
A single dose of GT005 will be administered with subretinal injection via suprachoroidal cannulation approach
Group III: GT005 Dose 3Experimental Treatment1 Intervention
A single dose of GT005 will be administered via subretinal injection
Group IV: GT005 Dose 2 with Orbit Subretinal Delivery SystemExperimental Treatment2 Interventions
A single dose of GT005 will be administered with subretinal injection via suprachoroidal cannulation approach
Group V: GT005 Dose 2Experimental Treatment1 Intervention
A single dose of GT005 will be administered via subretinal injection
Group VI: GT005 Dose 1, 2 or 3Experimental Treatment1 Intervention
A single dose of GT005 will be administered via subretinal injection. This dose will be determined by dose levels determined to be tolerable in Arms 1,2 and 3
Group VII: GT005 Dose 1Experimental Treatment1 Intervention
A single dose of GT005 will be administered via subretinal injection
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) injections, which reduce abnormal blood vessel growth and leakage in the retina, and photodynamic therapy, which uses light-activated drugs to destroy abnormal blood vessels. Gene therapy, such as the GT005 trial, aims to modify or correct genetic factors contributing to Macular Atrophy in AMD by delivering therapeutic genes to retinal cells.
This approach can potentially provide a long-term solution by addressing the underlying genetic causes of the disease, offering hope for more sustained and effective treatment outcomes for AMD patients.
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Who is running the clinical trial?
Gyroscope Therapeutics LimitedLead Sponsor
4 Previous Clinical Trials
661 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,913 Previous Clinical Trials
4,253,107 Total Patients Enrolled
Chief Medical OfficerStudy DirectorNovartis Pharmaceuticals
126 Previous Clinical Trials
21,995 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: GT005 Dose 3 with Orbit Subretinal Delivery Sysem
- Group 2: GT005 Dose 1, 2 or 3
- Group 3: GT005 Dose 3 with Orbit Subretinal Delivery System
- Group 4: GT005 Dose 2 with Orbit Subretinal Delivery System
- Group 5: GT005 Dose 3
- Group 6: GT005 Dose 1
- Group 7: GT005 Dose 2
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