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
  • End date
    Oct 25, 2022
  • participants needed
    330
  • sponsor
    Ionis Pharmaceuticals, Inc.
Updated on 29 November 2020
Investigator
Ionis Pharmaceuticals
Primary Contact
IONIS Investigative Site (6.7 mi away) Contact
+72 other location
vaccination
geographic atrophy
corrected visual acuity
mydriasis
atrophy
fundus autofluorescence imaging
pneumoniae
pupillary dilation
age-related macular degeneration
macular degeneration
fundus autofluorescence

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).

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, 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).

Details
Treatment Placebo, IONIS-FB-Lrx
Clinical Study IdentifierNCT03815825
SponsorIonis Pharmaceuticals, Inc.
Last Modified on29 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 50 yrs?
Gender: Male or Female
Do you have any of these conditions: Dry Macular Degeneration or Macular Degeneration or Geographic Atrophy or age-related macular degeneration?
Do you have any of these conditions: Macular Degeneration or Geographic Atrophy or Maculopathy or Dry Macular Degeneration or age-related macular degeneration?
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
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