Age-related Macular Degeneration // Clinical Trials // Kimberly Stepien // Past // Jun 12 2019
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).
Sponsor: Ionis Pharmaceuticals, Inc.
Principal Investigator: Kimberly Stepien, MD
Study Coordinator: Kris Dietzman
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, double-masked, randomized, stratified, placebo-controlled study conducted at multiple centers. It is an adaptive design in which three dose levels will be evaluated in a subset of patients (Stage 1) and, following an interim analysis, the number of patients in two of the dose cohorts will be expanded (Stage 2).
Diagnosis and Key Eligibility Criteria:
Age >/= 50 years at time of signing Informed Consent Form
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
Duration of Study: 18 months
For more information, contact Kris Dietzman 608-263-9035.