HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
- Conditions
- Dry Age-related Macular Degeneration
- Registration Number
- NCT04566445
- Lead Sponsor
- Gyroscope Therapeutics Limited
- Brief 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 255
- Able and willing to give written informed consent
- Age ≥55 years
- a. 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
- a. 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
- a. 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Progression of geographic atrophy 72 weeks The change from baseline to Week 72 in GA area as measured by fundus autofluorescence (FAF)
- Secondary Outcome Measures
Name Time Method Progression of geographic atrophy 96 weeks The change from baseline through Week 96 in GA area as measured by fundus autofluorescence (FAF)
Evaluation of the effect of GT005 on retinal anatomical measures 96 weeks Change in retinal morphology on multimodal imaging
Evaluation of the effect of GT005 on functional measures 96 weeks Change in low luminance difference (LLD) via the ETDRS chart
Evaluation of the effect of GT005 on visual function 96 weeks Change in functional reading independence (FRI) index
Evaluation of the safety and tolerability of GT005 96 weeks Frequency of treatment emergent adverse events (AEs)
Evaluation of the effect of GT005 on patient-reported outcomes 96 weeks Change in quality of life measured on the Visual Function Questionnaire-25 (VFQ-25)
Trial Locations
- Locations (62)
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Byers Eye Institute at Stanford
🇺🇸Palo Alto, California, United States
Retina Consultants of San Diego
🇺🇸Poway, California, United States
University of California (UC) Davis Medical Group Eye Center
🇺🇸Sacramento, California, United States
Rand Eye Institute
🇺🇸Deerfield Beach, Florida, United States
Southwest Retina Research Center
🇺🇸Durango, Colorado, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
VitreoRetinal Associates, P.A.
🇺🇸Gainesville, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Georgia Retina PC
🇺🇸Marietta, Georgia, United States
University Retina Macula Associates PC
🇺🇸Lemont, Illinois, United States
Retina Associates, LLC
🇺🇸Shawnee Mission, Kansas, United States
Midwest Eye Institute Northside
🇺🇸Indianapolis, Indiana, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Retina Associates of Michigan
🇺🇸Grand Blanc, Michigan, United States
Ophthalamic Consultants of Boston (OCB)
🇺🇸Boston, Massachusetts, United States
Associated Retinal Consultants PC
🇺🇸Royal Oak, Michigan, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Duke Eye Center
🇺🇸Durham, North Carolina, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Oregon Retina
🇺🇸Eugene, Oregon, United States
Mid Atlantic Retina - Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Erie Retinal Surgery ,INC
🇺🇸Erie, Pennsylvania, United States
Southeastern Retina Associates, PC
🇺🇸Knoxville, Tennessee, United States
Austin Research Center for Retina, PLLC
🇺🇸Austin, Texas, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Retina Consultants of Houston-TMC
🇺🇸Bellaire, Texas, United States
Texas Retina Associates (Dallas)
🇺🇸Dallas, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Department of Ophthalmology UW Medicine
🇺🇸Seattle, Washington, United States
Retina Center Northwest
🇺🇸Silverdale, Washington, United States
CHU Dijon - Hopital Mitterrand
🇫🇷Dijon, France
Centre Paradis Monticelli
🇫🇷Marseille, France
Sydney Hospital and Sydney Eye Hospital
🇦🇺Sydney, New South Wales, Australia
CHU de Nantes - Hôtel-Dieu
🇫🇷Nantes, France
Internationale Innovative Ophthalmochirurgie
🇩🇪Düsseldorf, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Lübeck
🇩🇪Lübeck, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Instituto de microcirugía ocular
🇪🇸Barcelona, Spain
Clinica Baviera
🇪🇸Madrid, Spain
Clinica Universidad de Navarra - Pamplona
🇪🇸Pamplona, Spain
Moorfields Eye Hospital - NHS Foundation Trust
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Retina Clinic London
🇬🇧London, United Kingdom
Sunderland Eye Infirmary
🇬🇧Sunderland, United Kingdom
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Illinois Retina Associates
🇺🇸Chicago, Illinois, United States
Oftalmika Spolka z ograniczona odpowiedzialnoscia
🇵🇱Bydgoszcz, Poland
The University of Melbourne - The Centre for Eye Research Australia (CERA)
🇦🇺Melbourne E., Victoria, Australia
Retinal Research Institute (retina consultants of AZ)
🇺🇸Phoenix, Arizona, United States
Casey Eye Institute - OHSU
🇺🇸Portland, Oregon, United States