EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (EXPLORE)
Dry Age-related Macular Degeneration
About this trial
This is an interventional treatment trial for Dry Age-related Macular Degeneration focused on measuring Geographic atrophy, Retinal disease, Eye disease, Retinal degeneration, Macular atrophy, Dry age-related macular degeneration
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
Sites / Locations
- Retinal Research Institute (retina consultants of AZ)
- Retina Associates of Southern California
- Byers Eye Institute at Stanford
- Retina Consultants San Diego
- VitreoRetinal Associates, P.A.
- Bascom Palmer Eye Institute
- Retina Vitreous Associates of Florida
- Southeast Retina Center
- University Retina Macula Associates PC
- Midwest Eye Institute Northside
- Wolfe Eye Clinic
- The Retina Care Center
- Ophthalmic Consultants of Boston (OCB)
- VitreoRetinal Surgery, PLLC
- Sierra Eye Associates
- Vision Research Center Eye Associates of New Mexico
- Columbia University Medical Center
- Retina Associates of Western New York
- Cincinnati Eye Institute
- Cleveland Clinic
- Oregon Retina
- Casey Eye Institute
- Erie Retinal Surgery, INC
- Mid Atlantic Retina
- Southeastern Retina Associates, PC
- Charles Retina Institute
- Austin Research Center for Retina, PLLC
- Retina Consultants of Houston-TMC
- Texas Retina Associates
- Retinal Consultants of San Antonio
- Department of Ophthalmology UW Medicine
- West Virginia University
- The University of Melbourne - The Centre for Eye Research Australia (CERA)
- Sydney Hospital and Sydney Eye Hospital
- Centre Paradis Monticelli
- CHU Hôpital F. Mitterrand
- CHU de Nantes - Hôtel-Dieu
- Universitaetsklinikum Schleswig-Holstein Campus Lübeck
- Universitaetsklinikum Bonn
- Internationale Innovative Ophthalmochirurgie
- St. Franziskus-Hospital
- Universitatsklinikum Tübingen
- Stichting Radboud Universitair Medisch Centrum
- Oftalmika Spolka z ograniczona odpowiedzialnoscia
- Hospital Universitari General de Catalunya
- Clinica Universidad de Navarra - Pamplona
- Hospital La Arruzafa
- Clinica Baviera
- Clinica Oftalvist Valencia
- Bristol Eye Hospital
- St.Paul's Eye Unit
- Moorfields Eye Hospital - NHS Foundation Trust
- The Retina Clinic London
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sunderland Eye Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
No Intervention
Experimental
No Intervention
Part 1 - GT005 Low Dose
Part 1 - GT005 High Dose
Part 1 - Untreated control
Part 2 - GT005 Low Dose
Part 2 - Untreated control
Approximately 25 subjects are planned, with subjects randomised to GT005 Low Dose.
Approximately 25 subjects are planned, with subjects randomised to GT005 High Dose.
Approximately 25 subjects are planned, with subjects randomised to untreated control.
Approximately 116 subjects are planned, with subjects randomised to Part 2 - GT005 Low Dose.
Approximately 54 subjects are planned, with subjects randomised to untreated control.