FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administere… (NCT03846193) | Clinical Trial Compass
TerminatedPhase 1/2
FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
Stopped: The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.
United States56 participantsStarted 2018-12-17
Plain-language 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).
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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 criteria
✕. 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
What they're measuring
1
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
Timeframe: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
2
Summary of Non-Ocular Treatment Emergent Adverse Events
Timeframe: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3
Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred
Timeframe: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
✕. 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