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)

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.

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