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Virus Therapy
GT005; Low Dose for Age-Related Macular Degeneration (EXPLORE Trial)
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
Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of <1%
GA lesion(s) within an acceptable size on FAF, in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
EXPLORE Trial Summary
This trial is testing an injection to see if it can improve vision in people with AMD.
Who is the study for?
This trial is for people aged 55 or older with a specific eye condition called geographic atrophy due to age-related macular degeneration. Participants must have decent vision in the study eye and be able to attend all visits. Women who can have children need a recent negative pregnancy test, unless they are postmenopausal or surgically sterilized.Check my eligibility
What is being tested?
The EXPLORE study tests two different doses of GT005 given as one injection under the retina to see if it's safe and works well for treating geographic atrophy secondary to age-related macular degeneration.See study design
What are the potential side effects?
Potential side effects from GT005 could include typical risks associated with subretinal injections such as discomfort, redness, bleeding, infection risk increase, retinal detachment, or inflammation inside the eye.
EXPLORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a rare genetic variant in the CFI gene.
Select...
My eye has GA lesions within a certain size range.
Select...
I can attend all required study visits and complete the procedures.
Select...
I am 55 years old or older.
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I have been diagnosed with GA due to AMD in one eye and AMD in the other.
EXPLORE Trial 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 moreEXPLORE Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 - GT005 Low DoseExperimental Treatment1 Intervention
Approximately 116 subjects are planned, with subjects randomised to Part 2 - GT005 Low Dose.
Group II: Part 1 - GT005 Low DoseExperimental Treatment1 Intervention
Approximately 25 subjects are planned, with subjects randomised to GT005 Low Dose.
Group III: Part 1 - GT005 High DoseExperimental Treatment1 Intervention
Approximately 25 subjects are planned, with subjects randomised to GT005 High Dose.
Group IV: Part 2 - Untreated controlActive Control1 Intervention
Approximately 54 subjects are planned, with subjects randomised to untreated control.
Group V: Part 1 - Untreated controlActive Control1 Intervention
Approximately 25 subjects are planned, with subjects randomised to untreated control.
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Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,252 Total Patients Enrolled
Gyroscope Therapeutics LimitedLead Sponsor
4 Previous Clinical Trials
619 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone gene or cell therapy.It is allowed for up to 25% of the participants to have a condition called CNV in their other eye.You have a medical or mental condition that the doctor thinks could be risky or affect the study results.My eye condition is due to diabetes and is moderate to severe.The area of concern in your eye must be fully visible in the images taken during the study.I have a rare genetic variant in the CFI gene.I might need cataract surgery in the eye being studied during the trial.I have severe glaucoma, high eye pressure despite medication, or had glaucoma surgery.My eye has GA lesions within a certain size range.I haven't had active cancer in the last year, except for certain treated cancers.I have not had eye surgery in the affected eye within the last 3 months.The subject has a vision of 6/95 or better when using ETDRS charts in the study eye.I can attend all required study visits and complete the procedures.I am not pregnant and have taken a test to confirm this within the last 2 weeks.I am 55 years old or older.I have had eye surgery or treatment for my retina in the study eye.I have been diagnosed with GA due to AMD in one eye and AMD in the other.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 - Untreated control
- Group 2: Part 1 - GT005 Low Dose
- Group 3: Part 2 - GT005 Low Dose
- Group 4: Part 1 - GT005 High Dose
- Group 5: Part 1 - Untreated control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Has GT005; Low Dose been approved by the FDA?
"There is a moderate amount of evidence suggesting the safety of GT005; Low Dose, so it was given an evaluation score of 2. However, no clinical data currently supports its efficacy."
Answered by AI
Are there any openings for volunteers in the current clinical trial?
"Affirmative. The information on clinicaltrials.gov denotes that this study is currently recruiting patients, having first been posted on July 14th 2020 and most recently updated December 1st 2021. 75 individuals must be recruited from 18 distinct sites."
Answered by AI
Are there numerous locales in the US at which this experiment is taking place?
"Patients are being recruited at Harkness Eye Institute, Charles Retina Institute and Cincinnati Eye Institute as well as 15 other clinical sites around the United States."
Answered by AI
How many volunteers have enrolled in the current research?
"Indeed, the data on clinicaltrials.gov verifies that this medical trial is presently enrolling patients. This research project was initially made public on July 14th 2020 and had its information updated most recently in December 1st 2021. The team behind it aims to recruit 75 individuals across 18 different sites."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Hawaii
How old are they?
65+
What site did they apply to?
Byers Eye Institute at Stanford
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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