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)
NCT03815825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 332
Last updated 2025-03-07
Summary
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).
Conditions
- Macular Degeneration
- Geographic Atrophy
Interventions
- DRUG
-
IONIS-FB-LRx
IONIS-FB-LRx at multiple ascending doses, administered subcutaneously every 4 weeks
- DRUG
-
Placebo matching solution, administered subcutaneously every 4 weeks
Sponsors & Collaborators
-
Ionis Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-04
- Primary Completion
- 2024-04-18
- Completion
- 2024-06-12
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Canada
- Czechia
- Netherlands
- New Zealand
- Poland
- Spain
Study Locations
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