Study Description
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).
Interventions
GT005; High Dose
GT005; Low Dose
Eligibility Criteria
Inclusion Criteria:
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
GA lesion(s) within an acceptable size on FAF, 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
Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of <1%
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 women who are postmenopausal or surgically sterilised)
Exclusion Criteria:
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.
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 intraocular pressure (IOP) despite the use of more than two topical agents, or a history of glaucoma-filtering or valve surgery
Axial myopia of greater than -8 diopters 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 the specified protocol corticosteroid regimen
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
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
Study Location
The University of Melbourne - The Centre for Eye Research Australia (CERA)
Recruiting
Melbourne E.,Victoria,Australia
Sydney Hospital and Sydney Eye Hospital
Recruiting
Sydney,2000,Australia
CHU Hôpital F. Mitterrand
Recruiting
Dijon,Bourgogne-Franche-Comté,21079,France
Centre Paradis Monticelli
Recruiting
Marseille,Alpes-Cote d'Azur,13008,France
CHU de Nantes - Hôtel-Dieu
Recruiting
Nantes,Pays De La Loire,44000,France
Makula-Netzhaut-Zentrum
Recruiting
Düsseldorf,40549,Germany
Universitaetsklinikum Schleswig-Holstein Campus Lübeck
Recruiting
Lübeck,Schleswig-Holstein,23538,Germany
Universitatsklinikum Tübingen
Recruiting
Tübingen,72076,Germany
Hospital Universitari General de Catalunya
Recruiting
Sant Cugat Del Vallès,Barcelona,08195,Spain
Clinica Universidad de Navarra - Pamplona
Recruiting
Pamplona,Navarra,31008,Spain
VISSUM Mirasierra
Recruiting
Madrid,Comunidad De Madrid,28035,Spain
Sunderland Eye Infirmary
Recruiting
Sunderland,SR2 9HP,United Kingdom
Retina Consultants San Diego
Recruiting
Poway,California,92064,United States
Wolfe Eye Clinic
Recruiting
West Des Moines,Iowa,50266,United States
The Retina Care Center
Recruiting
Baltimore,Maryland,21209,United States
Retina Vitreous Associates of Florida
Recruiting
Saint Petersburg,Florida,33711,United States
Bascom Palmer Eye Institute
Recruiting
Miami,Florida,33136,United States
Cincinnati Eye Institute
Recruiting
Cincinnati,Ohio,45242,United States
Sierra Eye Associates
Recruiting
Reno,Nevada,89502,United States
Byers Eye Institute at Stanford
Recruiting
Palo Alto,California,94303,United States
Mid Atlantic Retina
Recruiting
Philadelphia,Pennsylvania,19107,United States
Cleveland Clinic
Recruiting
Cleveland,Ohio,44195,United States
Southeast Retina Center
Recruiting
Augusta,Georgia,30909,United States
Casey Eye Institute
Recruiting
Portland,Oregon,97239,United States
Midwest Eye Institute Northside
Recruiting
Indianapolis,Indiana,46290,United States
Ophthalmic Consultants of Boston (OCB)
Recruiting
Boston,Massachusetts,02114,United States
Department of Ophthalmology UW Medicine
Recruiting
Seattle,Washington,98104-2499,United States
Charles Retina Institute
Recruiting
Memphis,Tennessee,38138,United States
Retina Associates of Western New York
Recruiting
Rochester,New York,14620,United States
West Virginia University
Recruiting
Morgantown,West Virginia,26506,United States
Harkness Eye Institute
Recruiting
New York,New York,10032,United States
Texas Retina Associates
Recruiting
Dallas,Texas,75231,United States
Worldwide Contacts
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