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Gene Therapy

GT005 for 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 weeks
Awards & highlights

Study Summary

This trial will test a new treatment for macular atrophy, a condition that leads to blindness.

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.Check my eligibility
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.See study design
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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~240 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 240 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of ocular and non-ocular Treatment Emergent AEs (TEAEs) and Treatment-Emergent Serious AEs (TESAEs) Severe Adverse Events (TEAE/TESAE)
Secondary outcome measures
Geographic Atrophy
Incidence of device-related AEs and SAEs (US only)
Long-term safety of GT005 at 3 doses
+4 more

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

Find a Location

Who is running the clinical trial?

Gyroscope Therapeutics LimitedLead Sponsor
4 Previous Clinical Trials
661 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,294 Total Patients Enrolled
Chief Medical OfficerStudy DirectorNovartis Pharmaceuticals
122 Previous Clinical Trials
21,468 Total Patients Enrolled

Media Library

Age-Related Macular Degeneration Research Study Groups: GT005 Dose 3 with Orbit Subretinal Delivery Sysem, GT005 Dose 1, 2 or 3, GT005 Dose 3 with Orbit Subretinal Delivery System, GT005 Dose 2 with Orbit Subretinal Delivery System, GT005 Dose 3, GT005 Dose 1, GT005 Dose 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this medical experiment striving to accomplish?

"The primary endpoint of this 48-week trial is to evaluate the occurrence and intensity of Treatment Emergent Adverse Events /Treatment Emergent Severe Adverse Events (TEAE/TESAE). Secondary metrics comprise Visual Acuity change from baseline as assessed by Early Treatment Diabetic Retinopathy Study chart, alteration in Drusen Volume measured in mm3, and proportion of successful delivery of Balanced Salt Solution or BSS PLUS into the subretinal space (only for US participants)."

Answered by AI

In what quantity of medical facilities is this research endeavor being conducted?

"This investigation is currently recruiting at 8 different sites, including those located in Indianapolis, Cincinnati and Chesterfield. It may be convenient to select the nearest location so as to reduce your transit needs if you take part in this trial."

Answered by AI

Is there any availability for participants in this investigation?

"In accordance with the information on clinicaltrials.gov, this trial has ceased recruiting candidates. Initially posted on December 17th 2018 and last updated October 10th 2022, it is no longer taking part in patient recruitment; however, there are currently 495 other medical trials actively seeking participants."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
Florida
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Sierra Eye Associates
Cincinnati Eye Institute
How many prior treatments have patients received?
1
3+
Recent research and studies
Gene TherapyJournal
Functional Expression of Complement Factor I Following Aav-mediated Gene Delivery in the Retina of Mice and Human Cells
Dreismann, Anna K., Michelle E. McClements, Alun R. Barnard, Elise Orhan, Jane P. Hughes, Peter J. Lachmann, and Robert E. MacLaren. 2021. “Functional Expression of Complement Factor I Following Aav-mediated Gene Delivery in the Retina of Mice and Human Cells”. Gene Therapy. Springer Science and Business Media LLC. doi:10.1038/s41434-021-00239-9.
clinicaltrials.govStudy
FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
2018. "FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03846193.
All > Age Related Macular Degeneration > Geographic Atrophy
~2 spots leftby Jun 2024
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