Status:
TERMINATED
EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
Lead Sponsor:
Gyroscope Therapeutics Limited
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Dry Age-related Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief 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-rela...
Detailed Description
This was a Phase II, outcomes assessor-masked, multicentre, randomized study to assess the safety and efficacy of two doses of GT005 administered as a single-time subretinal injection in subjects with...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
April 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04437368
Start Date
April 26 2019
End Date
April 5 2024
Last Update
September 2 2025
Active Locations (55)
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1
Retinal Research Institute (retina consultants of AZ)
Phoenix, Arizona, United States, 85053
2
Retina Associates of Southern California
Huntington Beach, California, United States, 92647
3
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
4
Retina Consultants San Diego
Poway, California, United States, 92064