This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
975
Barnet Dulaney Perkins Eye Center-Ophthamalogy
Chandler, Arizona, United States
RECRUITINGBarnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
RECRUITINGAssociated Retina Consultants
Phoenix, Arizona, United States
RECRUITINGRetinal Research Institute
Phoenix, Arizona, United States
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF)
Time frame: To week 52
Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from baseline
Time frame: At week 52 and week 104
Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA)
Time frame: At week 52 and week 104
Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA)
Time frame: At week 52 and week 104
Change from baseline in quantitative Contrast Sensitivity Function (qCSF)
Time frame: At week 52 and week 104
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF
Time frame: To week 104
Concentrations of total pozelimab in serum
Time frame: Through week 52 and through week 104
Concentrations of total cemdisiran in plasma
Time frame: Through week 52 and through week 104
Change from baseline in concentration of total Complement component 5 (C5)
Time frame: Through week 52 and through week 104
Incidence of Antidrug antibody (ADA) to pozelimab
Time frame: Through week 52 and through week 104
Magnitude of ADA to pozelimab
Time frame: Through week 52 and through week 104
Incidence of ADA to cemdisiran
Time frame: Through week 52 and through week 104
Magnitude of ADA to cemdisiran
Time frame: Through week 52 and through week 104
Incidence of Neutralizing Antibody (NAb) to pozelimab
Time frame: Through week 52 and through week 104
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through week 52, 104, 140 and week 296
Severity of TEAEs
Time frame: Through week 52, 104, 140 and week 296
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States
RECRUITINGRetina Associates of Tuscan
Tucson, Arizona, United States
RECRUITINGRetina Partners of Northwest Arkansas, PLLC
Springdale, Arkansas, United States
RECRUITINGRetina Vitreous Associates Medical Group
Beverly Hills, California, United States
RECRUITINGRetina Specialists of Beverly Hills- Department of Ophthalmology
Beverly Hills, California, United States
RECRUITINGThe Retina Partners
Encino, California, United States
RECRUITING...and 206 more locations