This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
RO730359 will be administered as a single intravitreal injection.
Northern California Retina Vitreous Associates
Mountain View, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
California Retina Consultants - Santa Maria
Santa Maria, California, United States
Colorado Retina Associates, PC
Denver, Colorado, United States
Florida Eye Associates
Melbourne, Florida, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Associated Retinal Consultants PC
Royal Oak, Michigan, United States
Sierra Eye Associates
Reno, Nevada, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Tennessee Retina PC.
Nashville, Tennessee, United States
...and 2 more locations
Percentage of Participants With Ocular Adverse Events
Time frame: Up to 12 weeks
Percentage of Participants With Systemic Adverse Events
Time frame: Up to 12 weeks
Percentage of Participants With Dose-limiting Adverse Events (DLAEs),
Time frame: Up to 12 weeks
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 12 weeks
Percentage of Participants With Adverse Events Leading to Study Discontinuation
Time frame: Up to 12 weeks
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to 12 weeks
Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Time frame: Baseline, Week 12
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