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Business objective change, no safety or efficacy concerns
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IONIS-FB-Lrx | Experimental |
| |
| Placebo (sterile saline 0.9%) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IONIS-FB-Lrx | Drug | Single Dose of IONIS-FB-Lrx administered once weekly for weeks 1-3, and every other week or less frequently until week 70 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of IONIS-FB-Lrx | The Efficacy of IONIS-FB-Lrx will be measured by the percent change in plasma complement factor B level | Up to 74 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx | 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 | Up to 86 weeks |
| Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IONIS Investigative Site | Phoenix | Arizona | 85014-2709 | United States | ||
| IONIS Investigational Site |
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Double Masked
| Placebo (sterline saline 0.9%) | Drug | Calculated volume to match active comparator. Administered subcutaneously weekly for weeks 1-3, and every other week or less frequently until week 70 |
|
Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B from Baseline to Post-Treatment |
| Up to 74 weeks |
| Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD | 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 | Up to 74 weeks |
| Effect of factor B reduction on other components of the complement pathways in AMD patients | 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 | Up to 74 weeks |
| Beverly Hills |
| California |
| 90211 |
| United States |
| IONIS Investigative Site | Encino | California | 91436 | United States |
| IONIS Investigative Site | Irvine | California | 92697 | United States |
| IONIS Investigational Site | Mountain View | California | 94040 | United States |
| IONIS Investigational Site | Santa Barbara | California | 93103 | United States |
| IONIS Investigative Site | Clearwater | Florida | 33761 | United States |
| IONIS Investigational Site | Tampa | Florida | 33612 | United States |
| IONIS Investigational Site | Augusta | Georgia | 30909 | United States |
| IONIS Investigational Site | Leawood | Kansas | 66211 | United States |
| IONIS Investigative Site | Chesterfield | Missouri | 63017 | United States |
| IONIS Investigative Site | New York | New York | 10021 | United States |
| IONIS Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| IONIS Investigative Site | Philadelphia | Pennsylvania | 19107-5109 | United States |
| IONIS Investigative Site | Pittsburgh | Pennsylvania | 15213 | United States |
| IONIS Investigational Site | Ladson | South Carolina | 29456 | United States |
| IONIS Investigative Site | Rapid City | South Dakota | 57701-7374 | United States |
| IONIS Investigative Site | Arlington | Texas | 76012-2505 | United States |
| IONIS Investigational Site | Austin | Texas | 78705 | United States |
| IONIS Investigative Site | Dallas | Texas | 75231-5078 | United States |
| IONIS Investigative Site | Houston | Texas | 77030-2727 | United States |
| IONIS Investigative Site | McAllen | Texas | 78503-1518 | United States |
| IONIS Investigative Site | San Antonio | Texas | 78240-1502 | United States |
| IONIS Investigative Site | The Woodlands | Texas | 77384-8018 | United States |
| Eye Clinic Albury Wodonga | Albury | New South Wales | 2640 | Australia |
| IONIS Investigational Site | Liverpool | New South Wales | 2170 | Australia |
| Marsden Eye Specialists | Parramatta | New South Wales | 2150 | Australia |
| Strathfield Retina Clinic | Strathfield | New South Wales | 2135 | Australia |
| Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia |
| Sydney Retina Clinic Day Surgery | Sydney | New South Wales | 2000 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| The Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria | 3002 | Australia |
| Retinology Institute | Glen Iris | Victoria | 3146 | Australia |
| Eye Surgery Associates | Malvern | Victoria | 3144 | Australia |
| Eye Surgery Associates | Parkville | Victoria | 3050 | Australia |
| Lions Eye Institute | Nedlands | Western Australia | 6009 | Australia |
| Auckland Eye | Auckland | 1050 | New Zealand |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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