Study Summary
This trial is testing an injection to see if it can improve vision in people with AMD.
Eligible Conditions
- Age-Related Macular Degeneration (AMD)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 6 Secondary · Reporting Duration: 72 weeks and 96 weeks
Week 96
Progression of geographic atrophy
96 weeks
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
Evaluation of the effect of GT005 on visual function
Evaluation of the safety and tolerability of GT005
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
3 Treatment Groups
Untreated control
1 of 3
GT005 Low Dose
1 of 3
GT005 High Dose
1 of 3
Active Control
Experimental Treatment
75 Total Participants · 3 Treatment Groups
Primary Treatment: GT005; Low Dose · No Placebo Group · Phase 2
GT005 Low Dose
Drug
Experimental Group · 1 Intervention: GT005; Low Dose · Intervention Types: DrugGT005 High Dose
Drug
Experimental Group · 1 Intervention: GT005; High Dose · Intervention Types: DrugUntreated controlNoIntervention Group · 1 Intervention: Untreated control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks and 96 weeks
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,718 Previous Clinical Trials
3,525,312 Total Patients Enrolled
Gyroscope Therapeutics LimitedLead Sponsor
4 Previous Clinical Trials
594 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:This person is able and willing to give written consent that they are aware of the risks and benefits involved in the study.
The person has AMD in one eye and the other eye has a different, unrelated medical condition.
, at baseline
There were no GA lesions within an acceptable size on FAF, in the study eye, at baseline.
The subject has a vision of 6/95 or better when using ETDRS charts in the study eye.
Can attend all study visits and complete the study procedures.
Women who might become pregnant must have a negative pregnancy test two weeks before they are randomized, though this is not required for postmenopausal or surgically sterile women.
People who are 55 years or older.
The GA lesion(s) in the study eye must be within the FAF image.
Up to 25% of study participants are allowed to have a CNV in the other eye.
in the population
Having a rare genetic variant of the CFI gene, which is defined as having a minor allele frequency of less than 1% in the population.
Who else is applying?
What state do they live in?
| Hawaii | 50.0% |
| Florida | 50.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Byers Eye Institute at Stanford | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
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Conditions
Cancer Related
Treatments