Evaluate the effect of IONIS-FB-LRx on the rate of change of the area of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) measured by fundus autofluorescence (FAF).
The study will assess the rate of change of the area of GA secondary to AMD by measuring FAF in up to 330 participants with GA due to AMD being treated with IONIS-FB-LRx. The study is a Phase 2, double-masked, randomized, stratified, placebo-controlled study conducted at multiple centers. It is an adaptive design in which three dose levels will be evaluated in a subset of participants (Stage 1) and, following an interim analysis, the number of participants in two of the dose cohorts will be expanded (Stage 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
332
IONIS-FB-LRx at multiple ascending doses, administered subcutaneously every 4 weeks
Placebo matching solution, administered subcutaneously every 4 weeks
Rate of Change from Baseline in the Geographic Atrophy (GA) Area at Week 49, as Assessed by Retinal Imaging
Time frame: Week 49
Absolute change in the GA area from Baseline as measured by Fundus Autofluorescence (FAF)
Time frame: Baseline and up to Week 57
Percentage Change from Baseline in Levels of Factor B (FB) in Plasma
Time frame: Baseline and up to Week 49
Percentage Change from Baseline in Levels of Serum AH50 Activity
Time frame: Baseline and up to Week 49
Absolute Change from Baseline in Low Luminance Visual Acuity (LLVA)
Time frame: Baseline and up to Week 49
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IONIS Investigative Site
Phoenix, Arizona, United States
IONIS Investigative Site
Phoenix, Arizona, United States
IONIS Investigative Site
Phoenix, Arizona, United States
IONIS Investigative Site
Sun City, Arizona, United States
IONIS Investigative Site
Beverly Hills, California, United States
IONIS Investigative Site
Huntington Beach, California, United States
IONIS Investigative Site
La Jolla, California, United States
IONIS Investigative Site
Long Beach, California, United States
IONIS Investigative Site
Poway, California, United States
IONIS Investigative Site
San Francisco, California, United States
...and 78 more locations