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NCT03815825 Clinical Trial

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 Clinical Trial

Official title:
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 (AMD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03815825
Other study ID # ISIS 696844-CS5
Secondary ID 2020-005174-94
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 4, 2019
Est. completion date June 2024

Study information
Verified date May 2024
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 participants (Stage 1) and, following an interim analysis, the number of participants in two of the dose cohorts will be expanded (Stage 2).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 332
Est. completion date June 2024
Est. primary completion date April 18, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IONIS-FB-LRx
IONIS-FB-LRx at multiple ascending doses, administered subcutaneously every 4 weeks
• Placebo
Placebo matching solution, administered subcutaneously every 4 weeks

Locations
Country Name City State
Australia IONIS Investigative Site Adelaide South Australia
Australia IONIS Investigative Site Albury New South Wales
Australia IONIS Investigative Site East Melbourne Victoria
Australia IONIS Investigative Site Essendon Victoria
Australia IONIS Investigative Site Glen Iris Victoria
Australia IONIS Investigative Site Hurstville New South Wales
Australia IONIS Investigative Site Malvern Victoria
Australia IONIS Investigative Site Parkville Victoria
Australia IONIS Investigative Site Parramatta New South Wales
Australia IONIS Investigative Site Perth Western Australia
Australia IONIS Investigative Site Sydney New South Wales
Austria IONIS Investigative Site Klagenfurt
Austria IONIS Investigative Site Linz Oberösterreich
Austria IONIS Investigative Site Vienna
Austria IONIS Investigative Site Vienna
Canada IONIS Investigative Site London Ontario
Canada IONIS Investigative Site Ottawa Ontario
Canada IONIS Investigative Site Ottawa Ontario
Canada IONIS Investigative Site Québec Quebec
Czechia IONIS Investigative Site Prague
Netherlands IONIS Investigative Site Nijmegen Gelderland
Netherlands IONIS Investigative Site Rotterdam
New Zealand IONIS Investigative Site Christchurch
Poland IONIS Investigative Site Bydgoszcz
Poland IONIS Investigative Site Katowice Silesian
Spain IONIS Investigative Site Barcelona
Spain IONIS Investigative Site Barcelona
Spain IONIS Investigative Site Burjassot Valencia
Spain IONIS Investigative Site Majadahonda Madrid
Spain IONIS Investigative Site Pamplona Navarra
Spain IONIS Investigative Site Terrassa Barcelona
Spain IONIS Investigative Site Valladolid
Spain IONIS Investigative Site Zaragoza
United States IONIS Investigative Site Abilene Texas
United States IONIS Investigative Site Albuquerque New Mexico
United States IONIS Investigative Site Arlington Texas
United States IONIS Investigative Site Asheville North Carolina
United States IONIS Investigative Site Augusta Georgia
United States IONIS Investigative Site Austin Texas
United States IONIS Investigative Site Baltimore Maryland
United States IONIS Investigative Site Baltimore Maryland
United States IONIS Investigative Site Bellaire Texas
United States IONIS Investigative Site Beverly Hills California
United States IONIS Investigative Site Clearwater Florida
United States IONIS Investigative Site Cleveland Ohio
United States IONIS Investigative Site Cleveland Ohio
United States IONIS Investigative Site Cleveland Ohio
United States IONIS Investigative Site Colorado Springs Colorado
United States IONIS Investigative Site Dallas Texas
United States IONIS Investigative Site Fort Myers Florida
United States IONIS Investigative Site Greenville South Carolina
United States IONIS Investigative Site Hagerstown Maryland
United States IONIS Investigative Site Hickory North Carolina
United States IONIS Investigative Site Huntington Beach California
United States IONIS Investigative Site La Jolla California
United States IONIS Investigative Site Ladson South Carolina
United States IONIS Investigative Site Lake Worth Florida
United States IONIS Investigative Site Lakeland Florida
United States IONIS Investigative Site Leawood Kansas
United States IONIS Investigative Site Lemont Illinois
United States IONIS Investigative Site Long Beach California
United States IONIS Investigative Site Lynchburg Virginia
United States IONIS Investigative Site McAllen Texas
United States IONIS Investigative Site Melbourne Florida
United States IONIS Investigative Site Nashville Tennessee
United States IONIS Investigative Site Philadelphia Pennsylvania
United States IONIS Investigative Site Phoenix Arizona
United States IONIS Investigative Site Phoenix Arizona
United States IONIS Investigative Site Phoenix Arizona
United States IONIS Investigative Site Pittsburgh Pennsylvania
United States IONIS Investigative Site Poway California
United States IONIS Investigative Site Richmond Virginia
United States IONIS Investigative Site Salt Lake City Utah
United States IONIS Investigative Site San Antonio Texas
United States IONIS Investigative Site San Francisco California
United States IONIS Investigative Site Silverdale Washington
United States IONIS Investigative Site Southaven Mississippi
United States IONIS Investigative Site Southlake Texas
United States IONIS Investigative Site Springfield Illinois
United States IONIS Investigative Site Stuart Florida
United States IONIS Investigative Site Sun City Arizona
United States IONIS Investigative Site Tampa Florida
United States IONIS Investigative Site The Woodlands Texas
United States IONIS Investigative Site Tulsa Oklahoma
United States IONIS Investigative Site West Mifflin Pennsylvania
United States IONIS Investigative Site Willow Park Texas
United States IONIS Investigative Site Winston-Salem North Carolina
United States IONIS Investigative Site Winter Haven Florida

Sponsors (1)
Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czechia,  Netherlands,  New Zealand,  Poland,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Change from Baseline in the Geographic Atrophy (GA) Area at Week 49, as Assessed by Retinal Imaging Week 49
Secondary Absolute change in the GA area from Baseline as measured by Fundus Autofluorescence (FAF) Baseline and up to Week 57
Secondary Percentage Change from Baseline in Levels of Factor B (FB) in Plasma Baseline and up to Week 49
Secondary Percentage Change from Baseline in Levels of Serum AH50 Activity Baseline and up to Week 49
Secondary Absolute Change from Baseline in Low Luminance Visual Acuity (LLVA) Baseline and up to Week 49
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