The purpose of this study is to assess the Safety and Efficacy of IONIS-FB-Lrx for up to 120 patients with Geographic Atrophy secondary to Age Related Macular Degeneration
This study will assess changes in complement factor B over a 69-week treatment period in a patient population 55 and older with well-demarcated Geographic Atrophy secondary to Age Related Macular Degeneration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Single Dose of IONIS-FB-Lrx administered once weekly for weeks 1-3, and every other week or less frequently until week 70
Calculated volume to match active comparator. Administered subcutaneously weekly for weeks 1-3, and every other week or less frequently until week 70
Efficacy of IONIS-FB-Lrx
The Efficacy of IONIS-FB-Lrx will be measured by the percent change in plasma complement factor B level
Time frame: Up to 74 weeks
Incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx
The safety and tolerability of IONIS-FB-Lrx will be assessed by determining the incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx
Time frame: Up to 86 weeks
Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B
Proportion of patients in each treatment group achieving a \>50% reduction of plasma complement factor B from Baseline to Post-Treatment
Time frame: Up to 74 weeks
Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD
Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD as measured by Fundus Autofluorescence from Baseline to Post-Treatment
Time frame: Up to 74 weeks
Effect of factor B reduction on other components of the complement pathways in AMD patients
Effect of factor B reduction on other components of the complement pathways such as AH50, CH50 and Bb in AMD patients from Baseline to Post-Treatment
Time frame: Up to 74 weeks
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IONIS Investigative Site
Phoenix, Arizona, United States
IONIS Investigational Site
Beverly Hills, California, United States
IONIS Investigative Site
Encino, California, United States
IONIS Investigative Site
Irvine, California, United States
IONIS Investigational Site
Mountain View, California, United States
IONIS Investigational Site
Santa Barbara, California, United States
IONIS Investigative Site
Clearwater, Florida, United States
IONIS Investigational Site
Tampa, Florida, United States
IONIS Investigational Site
Augusta, Georgia, United States
IONIS Investigational Site
Leawood, Kansas, United States
...and 27 more locations