This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA). The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood and the fluid in the eye at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Administered per the protocol
Colorado Retina Associates
Lakewood, Colorado, United States
RECRUITINGOphthalmic Consultants of Boston
East Weymouth, Massachusetts, United States
RECRUITINGAustin Retina Associates
Austin, Texas, United States
RECRUITINGRetina Foundation of the Southwest
Dallas, Texas, United States
RECRUITINGRetina Consultants Texas
The Woodlands, Texas, United States
RECRUITINGArensia Exploratory Medicine at the Research Institute of Clinical Medicine
Tbilisi, Georgia
RECRUITINGEmanuelli Research and Development Center
Arecibo, Puerto Rico
RECRUITINGARENSIA Clinics SRL
Bucharest, Romania
RECRUITINGArensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, Romania
RECRUITINGOccurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye
Part A
Time frame: Through week 8
Occurrence of ocular TEAEs in the study eye
Part B
Time frame: Through week 16
Occurrence of systemic TEAEs
Part A
Time frame: Through week 8
Occurrence of systemic TEAEs
Part B
Time frame: Through week 16
Concentrations of pozelimab in serum
Part A
Time frame: Through week 8
Concentrations of pozelimab in serum
Part B
Time frame: Through week 16
Occurrence of Anti-Drug Antibody (ADA) to pozelimab
Part A
Time frame: Through week 8
Magnitude of ADA to pozelimab
Part A
Time frame: Through week 8
Occurrence of ADA to pozelimab
Part B
Time frame: Through week 16
Magnitude of ADA to pozelimab
Part B
Time frame: Through week 16
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