HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
a study on Macular Degeneration Geographic Atrophy
Summary
- Eligibility
- for people ages 55 years and up (full criteria)
- Location
- at UC Davis
- Dates
- study startedcompletion around
Description
Summary
The purpose of this clinical study is 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).
Official Title
HORIZON: A Phase II, Open-label, Outcomes-assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
Details
This is a Phase 2, open-label, outcomes-assessor masked, multicentre, randomised, controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.
The trial includes a screening period of up to 8 weeks and a 96-week study period.
Subjects will be randomised to one of two groups; GT005 or the untreated control group.
Keywords
Dry Age-related Macular Degeneration, Geographic atrophy, Retinal disease, Eye disease, Retinal degeneration, Macular atrophy, Macular Degeneration, GT005: Medium Dose, GT005: High Dose
Eligibility
You can join if…
Open to people ages 55 years and up
- Able and willing to give written informed consent
- Age ≥55 years
- 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
- In Stage 1: Meet one of the pre-specified AMD genetic subgroup criteria; b. In
Stage 2: Genotyping is not required for study eligibility
- 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 (not required for postmenopausal women) or provide documentation of being surgically sterilised
You CAN'T join if...
- 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
- 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
- Have received any investigational product 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
- Have received a gene or cell therapy at any time.
- Have a contraindication to the protocol specified corticosteroid regimen
- 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
- 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
Locations
- University of California (UC) Davis Medical Group Eye Center
Sacramento California 95817 United States - Retina Vitreous Associates Medical Group
Beverly Hills California 90211 United States - Retina Consultants of San Diego
Poway California 92064 United States - Retina Consultants of Orange County
Fullerton California 92835 United States - Byers Eye Institute at Stanford
Palo Alto California 94303 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Gyroscope Therapeutics Limited
- ID
- NCT04566445
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- About 255 people participating
- Last Updated