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Ionis GOLDEN Study - Geographic Atrophy AMD

A Phase 2, Randomized Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Study Description:

Condition or Disease

Intervention / Treatment

Phase

Sponsor

Status

Geographic Atrophy

IONIS-FB-LRx

Other: Sham

Phase 2

IONIS

Currently Enrolling


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).

Eligibility Criteria:

  • Ages Eligible:  50 Years and Older
  • Sexes Eligible:  All

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.

Contact:
Middleburg Heights Office - Susan Rath 440-663-0022    •  
  srath@retina-assoc.com

To learn more:
https://clinicaltrials.gov/ct2/show/NCT03815825