EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (NCT04437368) | Clinical Trial Compass
TerminatedPhase 2
EXPLORE: 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 States98 participantsStarted 2019-04-26
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
✓. 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)
✓. Have GA lesion(s) total size between or equal to 1.25mm2 to 17.5mm2 in the study eye
✓. The GA lesion(s) 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, 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
Exclusion criteria
✕. Subjects who have a clinical diagnosis of Stargardt Disease or other retinal dystrophies, confirmed by the central reading centre
✕. 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
What they're measuring
1
The Change From Baseline to Week 48 in Geographic Atrophy (GA) - Part 1
✕. History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminium 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 two or more topical agents; a history of glaucoma-filtering or valve surgery is also excluded
✕. Axial myopia of greater than -8 dioptres in the study eye