The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.
This is a Phase 1, multicenter, open-label, single-dose, dose-escalation study in subjects with GA secondary to dry AMD to investigate the safety, tolerability, pharmacodynamics (PD), and immunogenicity of IVT injections of GEM103 to a single eye. The study is designed to identify the MTD for IVT administration of GEM103. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of DLTs. Three escalating dose cohorts are planned. Subjects will undergo clinical and ophthalmic assessments for inclusion eligibility into the study. Enrolled subjects will receive GEM103 and be followed for safety, PK, clinical, and biomarker evaluations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
GEM103
Associated Retina Consultants
Phoenix, Arizona, United States
Retinal Consultants of Arizona
Phoenix, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Retina Vitreous Associates
Beverly Hills, California, United States
California Retina Consultants
Oxnard, California, United States
California Retina Consultants
Santa Barbara, California, United States
California Retina Consultants
Santa Maria, California, United States
Southeast Retina Center
Augusta, Georgia, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
...and 2 more locations
Incidence and severity of AEs/SAEs following drug administration
Time frame: Up to 8 Weeks
GEM103 concentrations in ocular fluids
Time frame: Up to 8 Weeks
Changes in complement factor levels compared to baseline after drug administration
Time frame: Up to 8 Weeks
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