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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Macular Degeneration, Geographic Atrophy

In brief

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).

Key facts

Study ID

NCT03815825

Run by

Ionis Pharmaceuticals, Inc.

People needed

332

Starts

2019-03-04

Expected to finish

2024-06-12

Last updated by the study team

2025-03-07

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
• Vaccination against Neisseria meningitidis and Streptococcus pneumoniae received at least 2 weeks prior to first dose of investigational product
• Well-demarcated geographic atrophy (GA) due to AMD
• Best-corrected visual acuity (BCVA) letter score of 35 letters (approx. 20/200 Snellen equivalent) or better on the ETDRS chart
• Must have clear ocular media and adequate pupillary dilation in the study eye to permit high-quality fundus imaging

You may not qualify if…

• Clinically-significant abnormalities in medical history
• A lack of full recovery from any infection for at least 14 days prior to the Study Drug administration
• Chronic treatment with steroids, including topically or intravitreally administered
• History or presence of diabetic retinopathy or diabetic macular edema (DME)
• History or presence of a disease other than AMD that could affect vision or safety assessments
• Prior treatment with another investigational drug, biological agent, or device
• Other protocol-specified inclusion/exclusion criteria may apply

Where it is running

• 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
• IONIS Investigative Site — Colorado Springs, Colorado, United States
• IONIS Investigative Site — Clearwater, Florida, United States
• IONIS Investigative Site — Fort Myers, Florida, United States
• IONIS Investigative Site — Lake Worth, Florida, United States
• IONIS Investigative Site — Lakeland, Florida, United States
• IONIS Investigative Site — Melbourne, Florida, United States
• IONIS Investigative Site — Stuart, Florida, United States
• IONIS Investigative Site — Tampa, Florida, United States
• IONIS Investigative Site — Winter Haven, Florida, United States
• IONIS Investigative Site — Augusta, Georgia, United States
• IONIS Investigative Site — Lemont, Illinois, United States
• IONIS Investigative Site — Springfield, Illinois, United States
• IONIS Investigative Site — Leawood, Kansas, United States
• IONIS Investigative Site — Baltimore, Maryland, United States
• IONIS Investigative Site — Baltimore, Maryland, United States
• IONIS Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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