Status:
COMPLETED
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)
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Macular Degeneration
Geographic Atrophy
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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).
Detailed 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, doubl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT03815825
Start Date
March 4 2019
End Date
June 12 2024
Last Update
March 7 2025
Active Locations (88)
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1
IONIS Investigative Site
Phoenix, Arizona, United States, 85020
2
IONIS Investigative Site
Phoenix, Arizona, United States, 85021
3
IONIS Investigative Site
Phoenix, Arizona, United States, 85053
4
IONIS Investigative Site
Sun City, Arizona, United States, 85351