Status:
WITHDRAWN
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)
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Geographic Atrophy
Age Related Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
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
Detailed Description
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 Dege...
Eligibility Criteria
Inclusion
- Key
- Must have given written informed consent and be able to comply with study requirements
- 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)
- Well-demarcated Geographic Atrophy due to Age Related Macular Degeneration
- Key
Exclusion
- Clinically-significant abnormalities in medical history
- Diagnosis of primary or secondary immunodeficiencies of B lymphocyte function, splenectomy, glomerulonephritis or history of recurrent meningococcal disease
- Diabetes mellitus or thyroid disease unless well controlled for a period of at least 3 months
- Clinically-significant abnormalities in screening laboratory values
- Unwillingness to be administered, or history of a serious reaction to protocol required vaccines
- Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- History or presence of a disease other than AMD in study eye
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03446144
Start Date
March 16 2018
End Date
October 10 2018
Last Update
August 13 2019
Active Locations (37)
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1
IONIS Investigative Site
Phoenix, Arizona, United States, 85014-2709
2
IONIS Investigational Site
Beverly Hills, California, United States, 90211
3
IONIS Investigative Site
Encino, California, United States, 91436
4
IONIS Investigative Site
Irvine, California, United States, 92697