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)
Macular Degeneration, Geographic Atrophy
About this trial
This is an interventional treatment trial for Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- IONIS Investigative Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
IONIS-FB-LRx
Placebo
Stage 1 participants will receive IONIS-FB-LRx randomized to 1 of 3 dose levels, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 will expand 2 of the dosing cohorts in a new randomized group of participants based on the Stage 1 interim analysis. Participants will be randomized to 1 of 2 of the expanded cohorts, administered subcutaneously every 4 weeks, completing the treatment period at Week 45.
Stage 1 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45.