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Status: | Withdrawn |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 |
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
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
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
sites
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