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)
- Conditions
- Geographic AtrophyAge Related Macular Degeneration
- Interventions
- Drug: Placebo (sterline saline 0.9%)
- Registration Number
- NCT03446144
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IONIS-FB-Lrx IONIS-FB-Lrx - Placebo (sterile saline 0.9%) Placebo (sterline saline 0.9%) -
- Primary Outcome Measures
Name Time Method Efficacy of IONIS-FB-Lrx Up to 74 weeks The Efficacy of IONIS-FB-Lrx will be measured by the percent change in plasma complement factor B level
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx Up to 86 weeks The safety and tolerability of IONIS-FB-Lrx will be assessed by determining the incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx
Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B Up to 74 weeks Proportion of patients in each treatment group achieving a \>50% reduction of plasma complement factor B from Baseline to Post-Treatment
Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD Up to 74 weeks Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD as measured by Fundus Autofluorescence from Baseline to Post-Treatment
Effect of factor B reduction on other components of the complement pathways in AMD patients Up to 74 weeks Effect of factor B reduction on other components of the complement pathways such as AH50, CH50 and Bb in AMD patients from Baseline to Post-Treatment
Trial Locations
- Locations (13)
Sydney Retina Clinic Day Surgery
🇦🇺Sydney, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia
Eye Surgery Associates
🇦🇺Parkville, Victoria, Australia
Retinology Institute
🇦🇺Glen Iris, Victoria, Australia
The Royal Victorian Eye and Ear Hospital
🇦🇺East Melbourne, Victoria, Australia
Strathfield Retina Clinic
🇦🇺Strathfield, New South Wales, Australia
Sydney Eye Hospital
🇦🇺Sydney, New South Wales, Australia
Eye Clinic Albury Wodonga
🇦🇺Albury, New South Wales, Australia
IONIS Investigative Site
🇺🇸The Woodlands, Texas, United States
IONIS Investigational Site
🇦🇺Liverpool, New South Wales, Australia
Marsden Eye Specialists
🇦🇺Paramatta, New South Wales, Australia
Auckland Eye
🇳🇿Auckland, New Zealand