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)



Status:Withdrawn
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - Any
Updated:10/27/2018
Start Date:March 16, 2018
End Date:October 10, 2018

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A Phase 2, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of ISIS 696844, an Antisense Inhibitor of Complement Factor B, in Patients With Geographic Atrophy Secondary (GA) to Age-Related Macular Degeneration (AMD)

The purpose of this study is to assess the Safety and Efficacy of IONIS-FB-Lrx for up to 120
patients with Geographic Atrophy secondary to Age Related Macular Degeneration

This study will assess changes in complement factor B over a 69-week treatment period in a
patient population 55 and older with well-demarcated Geographic Atrophy secondary to Age
Related Macular Degeneration

Key Inclusion Criteria:

1. Must have given written informed consent and be able to comply with study requirements

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

Key Exclusion Criteria:

1. Clinically-significant abnormalities in medical history

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
We found this trial at
24
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New York, New York 10016
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669 Dean Street
Albury, New South Wales 2640
Phone: 02 7022 4824
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Arlington, Texas 76012
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Augusta, Georgia 30909
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Austin, Texas 78705
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Beverly Hills, California 90211
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Chesterfield, Missouri 63017
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Clearwater, Florida 33761
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Dallas, Texas 75390
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Encino, California 91436
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Houston, Texas 77030
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Irvine, California 92697
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Ladson, South Carolina 29456
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Leawood, Kansas 66211
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McAllen, Texas 78503
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Mountain View, California 94040
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85013
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Pittsburgh, Pennsylvania 15213
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Rapid City, South Dakota 57701
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San Antonio, Texas 78240
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Santa Barbara, California 93103
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Tampa, Florida 33612
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The Woodlands, Texas 77384
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