NCT03446144WithdrawnPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Ionis Pharmaceuticals, Inc.
- Locations
- 13
- Primary Endpoint
- Efficacy of IONIS-FB-Lrx
Study Overview
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 Degeneration
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Double Masked
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
IONIS-FB-Lrx
Experimental
Intervention: IONIS-FB-Lrx (Drug)
Placebo (sterile saline 0.9%)
Placebo Comparator
Intervention: Placebo (sterline saline 0.9%) (Drug)
Outcomes
Primary Outcomes
Efficacy of IONIS-FB-Lrx
Time Frame: Up to 74 weeks
The Efficacy of IONIS-FB-Lrx will be measured by the percent change in plasma complement factor B level
Secondary Outcomes
- Incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx(Up to 86 weeks)
- Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B(Up to 74 weeks)
- Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD(Up to 74 weeks)
- Effect of factor B reduction on other components of the complement pathways in AMD patients(Up to 74 weeks)
Investigators
Study Sites (13)
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