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

Korábbi kezelés

• 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
• Have a contraindication to specified protocol corticosteroid regimen
• Have received any investigational and/or approved product(s) 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 in the study eye or systemically
• Have received a gene or cell therapy at any time

Más betegség

• Subjects who have a clinical diagnosis of Stargardt Disease or other retinal dystrophies, confirmed by the central reading centre
• Have history of vitrectomy, sub-macular surgery, or macular photocoagulation 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
• 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
• 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

Egyéb

• 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
• Axial myopia of greater than -8 dioptres in the study eye
• Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant

• 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
• Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
• Part 1 Only: Subjects carrying a CFI rare variant genotype (minor allele frequency of ≤1%) previously associated with low serum CFI or subjects carrying an unreported CFI rare variant genotype that have tested to have a low serum CFI
• 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. 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)