FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD

Stopped early · Phase 1/Phase 2

Conditions studied: Dry Age-related Macular Degeneration, Macular Degeneration, Retinal Disease, Eye Diseases, Retinal Degeneration, Geographic Atrophy, Macular Atrophy

In brief

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).

Key facts

Study ID: NCT03846193
Run by: Gyroscope Therapeutics Limited
People needed: 56
Starts: 2018-12-17
Expected to finish: 2024-06-25
Last updated by the study team: 2026-01-28

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Midwest Eye Institute — Indianapolis, Indiana, United States
Wolfe Eye Clinic — West Des Moines, Iowa, United States
Ophthalamic Consultants of Boston (OCB) — Boston, Massachusetts, United States
Pepose Vision Institute — Chesterfield, Missouri, United States
Sierra Eye Associates — Reno, Nevada, United States
Cincinnati Eye Institute — Cincinnati, Ohio, United States
Mid-Atlantic Retina — Philadelphia, Pennsylvania, United States
Bristol Eye Hospital — Bristol, United Kingdom
Retina Clinic London — London, United Kingdom
Moorfields Eye Hospital — London, United Kingdom
Manchester Eye Hospital — Manchester, United Kingdom
Oxford University Hospital — Oxford, United Kingdom
Sunderland Eye Infirmary — Sunderland, United Kingdom

Full record on ClinicalTrials.gov

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