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Gene Therapy
GT005: High Dose for Age-Related Macular Degeneration
Phase 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
In Stage 1: 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
Age ≥55 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
Study Summary
This trial will test if GT005 is safe and effective for people with geographic atrophy due to AMD.
Who is the study for?
This trial is for people aged 55 or older with a specific eye condition called geographic atrophy (GA) due to age-related macular degeneration (AMD). Participants must have GA in one eye and AMD in the other, if not monocular. They should be able to attend all visits, consent to procedures, and women of childbearing potential need a negative pregnancy test or proof of sterilization. Exclusions include significant cataracts, certain genetic variants, prior gene therapy, extreme nearsightedness, recent investigational drug use for GA.Check my eligibility
What is being tested?
The HORIZON study tests two different doses of GT005 given as a single injection into the retina to see how safe and effective they are against GA secondary to AMD. The participants will receive either a high dose or medium dose randomly.See study design
What are the potential side effects?
While specific side effects aren't listed here, common risks from similar eye injections can include inflammation inside the eye, increased pressure within the eyeball that could lead to glaucoma-like symptoms, bleeding in the retina area where injected; infection risk; possible vision changes like blurriness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with advanced AMD in both eyes, with GA in one eye.
Select...
I am 55 years old or older.
Select...
My AMD falls into one of the specific genetic groups.
Select...
My eye has GA lesions within the acceptable size range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Evaluation of the effect of GT005 on functional measures
Evaluation of the effect of GT005 on patient-reported outcomes
Evaluation of the effect of GT005 on retinal anatomical measures
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: GT005 Medium DoseExperimental Treatment1 Intervention
Approximately 83 subjects are planned, with subjects randomised to GT005 Medium Dose.
Group II: GT005 High DoseExperimental Treatment1 Intervention
Approximately 83 subjects are planned, with subjects randomised to GT005 High Dose.
Group III: Untreated controlActive Control1 Intervention
Approximately 83 subjects are planned, with subjects randomised to untreated control.
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,095 Total Patients Enrolled
Gyroscope Therapeutics LimitedLead Sponsor
4 Previous Clinical Trials
462 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend all required study visits and complete the procedures.I have severe glaucoma not controlled by medication, or I've had surgery for it.The problem area in your eye that we are studying must be fully visible in the images we take.I have undergone gene or cell therapy.I have had eye surgery or treatment for my retina in the study eye.I have a specific type of advanced age-related eye disease in both eyes, as confirmed by my doctor.I had eye surgery in the affected eye within the last 3 months.I haven't had active cancer in the last year, except for certain treated cancers.My eye condition is due to diabetes and is moderate to severe.I do not have Stargardt Disease or any other retinal dystrophy.I do not have any major eye or other health issues that could affect my study participation.I don't need genetic testing to join Stage 2 of the study.I am not pregnant or have been surgically sterilized.I have been diagnosed with advanced AMD in both eyes, with GA in one eye.I am 55 years old or older.My AMD falls into one of the specific genetic groups.I might need cataract surgery in the study eye during the trial.I do not carry genetic variants that are excluded in Stage 1.I haven't taken experimental treatments for GA, except for AREDS, in the last 6 months.My eye has GA lesions within the acceptable size range.
Research Study Groups:
This trial has the following groups:- Group 1: GT005 Medium Dose
- Group 2: GT005 High Dose
- Group 3: Untreated control
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies in this study for participants?
"Yes, the listing on clinicaltrials.gov is current and affirms that this research endeavour is accepting applicants as of now. It was first posted September 28th 2020 and revised August 1st 2022; the trial needs approximately 250 enrollees across 45 sites."
Answered by AI
Has GT005: High Dose obtained FDA authorization?
"With evidence of safety in the Phase 2 trial, GT005: High Dose received a score of 2. There is yet to be data affirming effectiveness at this stage."
Answered by AI
What is the cap on participant numbers for this experiment?
"Yes, the research hosted on clinicaltrials.gov demonstrates that this trial is recruiting candidates as of August 1st 2022; it was first posted to the platform on September 28th 2020. A total of 250 individuals are required for enrolment at 45 different medical sites."
Answered by AI
How many separate facilities are overseeing this venture?
"This medical research is recruiting trial participants at SE Retina Associates in Knoxville, Tennessee, Northern California Retina Vitreous Associates in Mountain View, California and Retina Center Northwest in Silverdale Washington - along with 45 other locations."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Florida
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?
Retina Consultants of Orange County
Why did patients apply to this trial?
Hi staff, My name is Cesar I was born with RP, I wasn’t to be part of this Clinical Trail to help my self and other people that are struggling.
PatientReceived 1 prior treatment
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