HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (NCT04566445) | Clinical Trial Compass
TerminatedPhase 2
HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
Stopped: Terminated for interim analysis demonstrating futility (trial highly unlikely to meet efficacy outcome). The trial is not ending early because of medical problems or concerns.
United States255 participantsStarted 2020-09-28
Plain-language summary
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).
Who can participate
Age range55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
The Change From Baseline to Week 72 in Geographic Atrophy (GA)
. 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