Do you have dry, age-related macular degeneration (AMD)?
Consider enrolling in an interventional gene therapy study called HORIZON
a study on Macular Degeneration
Summary
- Eligibility
- for people ages 55 years and up (full criteria)
- Location
- at Sacramento, California and other locations
- Dates
- study startedestimated completion
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 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- Davis Medical Group Eye Center
accepting new patients
Sacramento California 95817 United States - Byers Eye Institute at Stanford
accepting new patients
Palo Alto California 94303 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Gyroscope Therapeutics Limited
- Links
- Sign up for this study
- ID
- NCT04566445
- Phase
- Phase 2 Macular Degeneration Research Study
- Study Type
- Interventional
- Participants
- Expecting 250 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.