Safety and Efficacy of IONIS-FB-Lrx in up to 120 Patients 55 and Older With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
NCT ID: NCT03446144
Last Updated: 2019-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2018-03-16
2018-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IONIS-FB-Lrx
IONIS-FB-Lrx
Single Dose of IONIS-FB-Lrx administered once weekly for weeks 1-3, and every other week or less frequently until week 70
Placebo (sterile saline 0.9%)
Placebo (sterline saline 0.9%)
Calculated volume to match active comparator. Administered subcutaneously weekly for weeks 1-3, and every other week or less frequently until week 70
Interventions
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IONIS-FB-Lrx
Single Dose of IONIS-FB-Lrx administered once weekly for weeks 1-3, and every other week or less frequently until week 70
Placebo (sterline saline 0.9%)
Calculated volume to match active comparator. Administered subcutaneously weekly for weeks 1-3, and every other week or less frequently until week 70
Eligibility Criteria
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Inclusion Criteria
2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile or, if engaged in sexual relations with a female of child bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least a period of 13 weeks after the last dose of Study Drug (ISIS 696844 or placebo)
3. Well-demarcated Geographic Atrophy due to Age Related Macular Degeneration
Exclusion Criteria
2. Diagnosis of primary or secondary immunodeficiencies of B lymphocyte function, splenectomy, glomerulonephritis or history of recurrent meningococcal disease
3. Diabetes mellitus or thyroid disease unless well controlled for a period of at least 3 months
4. Clinically-significant abnormalities in screening laboratory values
5. Unwillingness to be administered, or history of a serious reaction to protocol required vaccines
6. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
7. History or presence of a disease other than AMD in study eye
55 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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IONIS Investigative Site
Phoenix, Arizona, United States
IONIS Investigational Site
Beverly Hills, California, United States
IONIS Investigative Site
Encino, California, United States
IONIS Investigative Site
Irvine, California, United States
IONIS Investigational Site
Mountain View, California, United States
IONIS Investigational Site
Santa Barbara, California, United States
IONIS Investigative Site
Clearwater, Florida, United States
IONIS Investigational Site
Tampa, Florida, United States
IONIS Investigational Site
Augusta, Georgia, United States
IONIS Investigational Site
Leawood, Kansas, United States
IONIS Investigative Site
Chesterfield, Missouri, United States
IONIS Investigative Site
New York, New York, United States
IONIS Investigative Site
Philadelphia, Pennsylvania, United States
IONIS Investigative Site
Philadelphia, Pennsylvania, United States
IONIS Investigative Site
Pittsburgh, Pennsylvania, United States
IONIS Investigational Site
Ladson, South Carolina, United States
IONIS Investigative Site
Rapid City, South Dakota, United States
IONIS Investigative Site
Arlington, Texas, United States
IONIS Investigational Site
Austin, Texas, United States
IONIS Investigative Site
Dallas, Texas, United States
IONIS Investigative Site
Houston, Texas, United States
IONIS Investigative Site
McAllen, Texas, United States
IONIS Investigative Site
San Antonio, Texas, United States
IONIS Investigative Site
The Woodlands, Texas, United States
Eye Clinic Albury Wodonga
Albury, New South Wales, Australia
IONIS Investigational Site
Liverpool, New South Wales, Australia
Marsden Eye Specialists
Paramatta, New South Wales, Australia
Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic Day Surgery
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia
Retinology Institute
Glen Iris, Victoria, Australia
Eye Surgery Associates
Malvern, Victoria, Australia
Eye Surgery Associates
Parkville, Victoria, Australia
Lions Eye Institute
Nedlands, Western Australia, Australia
Auckland Eye
Auckland, , New Zealand
Countries
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Other Identifiers
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ISIS 696844-CS3
Identifier Type: -
Identifier Source: org_study_id
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