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NCT03815825CompletedPhase 2

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)

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)

Source: ClinicalTrials.gov · Last updated 7 Mar 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
332 (actual)
First submitted
22 Jan 2019
Start date
4 Mar 2019
Primary completion date
18 Apr 2024
Lead sponsor
Ionis Pharmaceuticals, Inc.
NCT number
NCT03815825
EudraCT number
2020-005174-94

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 332
  • From 4 Mar 2019 to the primary completion date, 18 Apr 2024
  • 80 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Prior treatment with another investigational drug, biological agent, or device

Other illness

  • History or presence of a disease other than AMD that could affect vision or safety assessments

Other

  • Clinically-significant abnormalities in medical history
  • History or presence of diabetic retinopathy or diabetic macular edema (DME)
  • Other protocol-specified inclusion/exclusion criteria may apply

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (80)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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KlagenfurtAustriaUnknown status
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LinzAustriaUnknown status
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ViennaAustriaUnknown status
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AdelaideAustraliaUnknown status
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AlburyAustraliaUnknown status
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East MelbourneAustraliaUnknown status
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EssendonAustraliaUnknown status
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Glen IrisAustraliaUnknown status
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HurstvilleAustraliaUnknown status
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MalvernAustraliaUnknown status
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ParkvilleAustraliaUnknown status
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ParramattaAustraliaUnknown status
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PerthAustraliaUnknown status
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SydneyAustraliaUnknown status
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LondonCanadaUnknown status
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OttawaCanadaUnknown status
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QuébecCanadaUnknown status
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PragueCzechiaUnknown status
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BarcelonaSpainUnknown status
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BurjassotSpainUnknown status
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MajadahondaSpainUnknown status
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PamplonaSpainUnknown status
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TerrassaSpainUnknown status
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ValladolidSpainUnknown status
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ZaragozaSpainUnknown status
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NijmegenNetherlandsUnknown status
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RotterdamNetherlandsUnknown status
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ChristchurchNew ZealandUnknown status
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BydgoszczPolandUnknown status
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KatowicePolandUnknown status
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AbileneUnited StatesUnknown status
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AlbuquerqueUnited StatesUnknown status
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ArlingtonUnited StatesUnknown status
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AshevilleUnited StatesUnknown status
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AugustaUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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BellaireUnited StatesUnknown status
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Beverly HillsUnited StatesUnknown status
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ClearwaterUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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Colorado SpringsUnited StatesUnknown status
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DallasUnited StatesUnknown status
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Fort MyersUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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HagerstownUnited StatesUnknown status
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HickoryUnited StatesUnknown status
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Huntington BeachUnited StatesUnknown status
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LadsonUnited StatesUnknown status
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La JollaUnited StatesUnknown status
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LakelandUnited StatesUnknown status
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Lake WorthUnited StatesUnknown status
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LeawoodUnited StatesUnknown status
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LemontUnited StatesUnknown status
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Long BeachUnited StatesUnknown status
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LynchburgUnited StatesUnknown status
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McAllenUnited StatesUnknown status
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MelbourneUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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PowayUnited StatesUnknown status
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RichmondUnited StatesUnknown status
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Salt Lake CityUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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SilverdaleUnited StatesUnknown status
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SouthavenUnited StatesUnknown status
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SouthlakeUnited StatesUnknown status
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SpringfieldUnited StatesUnknown status
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StuartUnited StatesUnknown status
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Sun CityUnited StatesUnknown status
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TampaUnited StatesUnknown status
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The WoodlandsUnited StatesUnknown status
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TulsaUnited StatesUnknown status
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West MifflinUnited StatesUnknown status
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Willow ParkUnited StatesUnknown status
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Winston-SalemUnited StatesUnknown status
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Winter HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.