Last updated on January 2020

GOLDEN STUDY: A Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRx in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)


Brief description of study

The purpose of the study is to 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).

Detailed Study Description

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 patients (Stage 1) and, following an interim analysis, the number of patients in two of the dose cohorts will be expanded (Stage 2).

Clinical Study Identifier: NCT03815825

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IONIS Investigative Site

East Melbourne, Australia
1.07miles
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IONIS Investigative Site

Parkville, Australia
2.84miles
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IONIS Investigative Site

Malvern, Australia
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IONIS Investigative Site

Glen Iris, Australia
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IONIS Investigative Site

Essendon, Australia
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