HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

Stopped early · Phase 2

Conditions studied: Dry Age-related Macular Degeneration

In brief

The purpose of this clinical study was to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

Key facts

Study ID

NCT04566445

Run by

Gyroscope Therapeutics Limited

People needed

255

Starts

2020-09-28

Expected to finish

2024-06-10

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 written informed consent
• Age ≥55 years
• a. 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; b. In Stage 2: Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, that is non-foveal, as determined by the central reading centre, or has a CFI rare variant genotype and meets inclusion criteria 3a, and a diagnosis of AMD in the contralateral eye (except if monocular)
• GA lesion(s) within an acceptable size on FAF, in the study eye
• The GA lesion in the study eye must reside completely within the FAF image
• Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye
• Have a BCVA of ≥24 letters (6/95 or 20/320 Snellen acuity equivalent), using ETDRS charts, in the study eye
• a. In Stage 1: Meet one of the pre-specified AMD genetic subgroup criteria; b. In Stage 2: Genotyping is not required for study eligibility
• Able to attend all study visits and complete the study procedures
• Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation (not required for postmenopausal women) or provide documentation of being surgically sterilised

You may not qualify if…

• a. In Stage 1: Carriers of excluded genetic variants; b. In Stage 2: Subjects are excluded if they have a clinical diagnosis of Stargardt Disease or other retinal dystrophies
• Have a history, or evidence, of CNV in the study eye
• Presence of moderate/severe or worse non-proliferative, diabetic retinopathy 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 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, uncontrolled intraocular pressure (IOP), despite use of two or more topical agents; or a history of glaucoma-filtering or valve surgery
• 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 protocol specified 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

Where it is running

• Retina Vitreous Associates Medical Group — Beverly Hills, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Byers Eye Institute at Stanford — Palo Alto, California, United States
• Retina Consultants of San Diego — Poway, California, United States
• University of California (UC) Davis Medical Group Eye Center — Sacramento, California, United States
• Southwest Retina Research Center — Durango, Colorado, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• VitreoRetinal Associates, P.A. — Gainesville, Florida, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina PC — Marietta, Georgia, United States
• Illinois Retina Associates — Chicago, Illinois, United States
• University Retina Macula Associates PC — Lemont, Illinois, United States
• Midwest Eye Institute Northside — Indianapolis, Indiana, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Retina Associates, LLC — Shawnee Mission, Kansas, United States
• The Retina Care Center — Baltimore, Maryland, United States
• Ophthalamic Consultants of Boston (OCB) — Boston, Massachusetts, United States
• Retina Associates of Michigan — Grand Blanc, Michigan, United States
• Associated Retinal Consultants PC — Royal Oak, Michigan, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Columbia University Medical Center — New York, New York, United States
• Retinal Research Institute (retina consultants of AZ) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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