Status:
TERMINATED
FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
Lead Sponsor:
Gyroscope Therapeutics Limited
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Dry Age-related Macular Degeneration
Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
PHASE1
PHASE2
Brief Summary
This was an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to Age-related macular degeneration (AMD).
Detailed Description
This was an open label first-in-human Phase I/II multicenter study to evaluate the safety, dose response and efficacy of GT005 in participants with Geographic atrophy (GA) due to Age-related macular d...
Eligibility Criteria
Inclusion
- Able and willing to give consent to study participation
- 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 6: GA lesion(s) total size in the study eye must be ≥1.25mm2 and ≤17.5mm2.
- Cohort 7: GA lesion(s) total size in the study eye must be ≥1.25mm2
- GA lesion(s) in the study eye must reside completely within the FAF fundus image
- Cohorts 1 to 3: BCVA of ≤50 letters (6/36 Snellen acuity equivalent or worse) using ETDRS charts in the study eye Cohorts 4 to 7: BCVA of ≥24 letters (6/95 and 20/320 Snellen acuity equivalent or better) using ETDRS charts in the study eye
- Aged ≥55 years
- Able to attend all study visits and complete the study procedures
- Women of child-bearing potential need to have a negative urine pregnancy test within two weeks prior to receiving the drug. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilised (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy)
Exclusion
- Have evidence or history of Choroidal Neovascularisation (CNV) in the study eye. Subjects are permitted to have CNV in the fellow eye defined as either:
- Non-exudative/sub-clinical fellow eye CNV identified at screening, or
- Known history of fellow eye CNV with either ≥2 years since diagnosis or with no active treatment required in 6 months prior to screening
- Presence of moderate/severe non-proliferative diabetic retinopathy or worse in the study eye
- Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
- History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminum garnet capsulotomy is permitted if performed \>10 weeks prior to Visit 1
- Have clinically significant cataract that may require surgery during the study period in the study eye
- Presence of moderate to severe glaucomatous optic neuropathy in the study eye; uncontrolled IOP despite the use of more than two topical agents; a history of glaucoma-filtering or valve surgery is also excluded
- Axial myopia of greater than -8 diopters 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
- Have received a gene or cell therapy at any time
- Have a contraindication to the specified protocol corticosteroid regimen
- Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
- Active malignancy within the past 12 months, except for: Appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) ≥12 months
- Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study
- Cohorts 5 to 7 only: presence of metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, and other implanted electrodes or stimulators
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03846193
Start Date
December 17 2018
End Date
June 25 2024
Last Update
August 24 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
2
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
3
Ophthalamic Consultants of Boston (OCB)
Boston, Massachusetts, United States, 02114
4
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017