Geographic Atrophy Secondary to Age-Related Macular Degeneration
Conditions
Brief summary
Growth rate (slope) of total GA lesion area (mm^2 /year) measured by Fundus Autofluorescence (FAF)
Detailed description
Loss of Best Corrected Visual Acuity (BCVA) ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS), Change in Low-contrast quantitative Visual Acuity (LC-qVA), Change in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA), Change in quantitative Contrast Sensitivity Function (qCSF), Growth rate (slope) of total GA lesion area (mm^2 /year) measured by FAF, Concentrations of total pozelimab in serum, Concentrations of total cemdisiran in plasma, Change in concentration of total Complement component 5 (C5), Incidence of Antidrug antibody (ADA) to pozelimab, Magnitude of ADA to pozelimab, Incidence of ADA to cemdisiran, Magnitude of ADA to cemdisiran, Incidence of Neutralizing antibody (NAb) to pozelimab, Occurrence of Treatment-emergent adverse events (TEAEs), Severity of TEAEs
Interventions
DRUGCemdisiran
DRUGPlacebo for pozelimab will be provided in an aqueous buffered solution and supplied by the sponsor.
DRUGPlacebo for cemdisiran is 0.9% saline and will be supplied by the sponsor.
DRUGPozelimab
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth rate (slope) of total GA lesion area (mm^2 /year) measured by Fundus Autofluorescence (FAF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Loss of Best Corrected Visual Acuity (BCVA) ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS), Change in Low-contrast quantitative Visual Acuity (LC-qVA), Change in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA), Change in quantitative Contrast Sensitivity Function (qCSF), Growth rate (slope) of total GA lesion area (mm^2 /year) measured by FAF, Concentrations of total pozelimab in serum, Concentrations of total cemdisiran in plasma, Change in concentration of total Complement component 5 (C5), Incidence of Antidrug antibody (ADA) to pozelimab, Magnitude of ADA to pozelimab, Incidence of ADA to cemdisiran, Magnitude of ADA to cemdisiran, Incidence of Neutralizing antibody (NAb) to pozelimab, Occurrence of Treatment-emergent adverse events (TEAEs), Severity of TEAEs | — |
Countries
Austria, France, Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed