Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005174-94 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the effect of IONIS-FB-LRx on the rate of change of the area of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) measured by fundus autofluorescence (FAF).
The study will assess the rate of change of the area of GA secondary to AMD by measuring FAF in up to 330 participants with GA due to AMD being treated with IONIS-FB-LRx. The study is a Phase 2, double-masked, randomized, stratified, placebo-controlled study conducted at multiple centers. It is an adaptive design in which three dose levels will be evaluated in a subset of participants (Stage 1) and, following an interim analysis, the number of participants in two of the dose cohorts will be expanded (Stage 2).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IONIS-FB-LRx | Experimental | Stage 1 participants will receive IONIS-FB-LRx randomized to 1 of 3 dose levels, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 will expand 2 of the dosing cohorts in a new randomized group of participants based on the Stage 1 interim analysis. Participants will be randomized to 1 of 2 of the expanded cohorts, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. |
|
| Placebo | Experimental | Stage 1 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IONIS-FB-LRx | Drug | IONIS-FB-LRx at multiple ascending doses, administered subcutaneously every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Change from Baseline in the Geographic Atrophy (GA) Area at Week 49, as Assessed by Retinal Imaging | Week 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in the GA area from Baseline as measured by Fundus Autofluorescence (FAF) | Baseline and up to Week 57 | |
| Percentage Change from Baseline in Levels of Factor B (FB) in Plasma | Baseline and up to Week 49 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IONIS Investigative Site | Phoenix | Arizona | 85020 | United States | ||
| IONIS Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37314061 | Derived | Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matching solution, administered subcutaneously every 4 weeks |
|
| Percentage Change from Baseline in Levels of Serum AH50 Activity | Baseline and up to Week 49 |
| Absolute Change from Baseline in Low Luminance Visual Acuity (LLVA) | Baseline and up to Week 49 |
| Phoenix |
| Arizona |
| 85021 |
| United States |
| IONIS Investigative Site | Phoenix | Arizona | 85053 | United States |
| IONIS Investigative Site | Sun City | Arizona | 85351 | United States |
| IONIS Investigative Site | Beverly Hills | California | 90211 | United States |
| IONIS Investigative Site | Huntington Beach | California | 92697 | United States |
| IONIS Investigative Site | La Jolla | California | 92093 | United States |
| IONIS Investigative Site | Long Beach | California | 90807 | United States |
| IONIS Investigative Site | Poway | California | 92064 | United States |
| IONIS Investigative Site | San Francisco | California | 94109 | United States |
| IONIS Investigative Site | Colorado Springs | Colorado | 80909 | United States |
| IONIS Investigative Site | Clearwater | Florida | 33761 | United States |
| IONIS Investigative Site | Fort Myers | Florida | 33907 | United States |
| IONIS Investigative Site | Lake Worth | Florida | 33461 | United States |
| IONIS Investigative Site | Lakeland | Florida | 33801 | United States |
| IONIS Investigative Site | Melbourne | Florida | 32901 | United States |
| IONIS Investigative Site | Stuart | Florida | 34994 | United States |
| IONIS Investigative Site | Tampa | Florida | 33612 | United States |
| IONIS Investigative Site | Winter Haven | Florida | 33880 | United States |
| IONIS Investigative Site | Augusta | Georgia | 30909 | United States |
| IONIS Investigative Site | Lemont | Illinois | 60439 | United States |
| IONIS Investigative Site | Springfield | Illinois | 62702 | United States |
| IONIS Investigative Site | Leawood | Kansas | 66211 | United States |
| IONIS Investigative Site | Baltimore | Maryland | 21204 | United States |
| IONIS Investigative Site | Baltimore | Maryland | 21209 | United States |
| IONIS Investigative Site | Hagerstown | Maryland | 21740 | United States |
| IONIS Investigative Site | Southaven | Mississippi | 38671 | United States |
| IONIS Investigative Site | Albuquerque | New Mexico | 87109 | United States |
| IONIS Investigative Site | Asheville | North Carolina | 28803 | United States |
| IONIS Investigative Site | Hickory | North Carolina | 28602 | United States |
| IONIS Investigative Site | Winston-Salem | North Carolina | 27157 | United States |
| IONIS Investigative Site | Cleveland | Ohio | 44106 | United States |
| IONIS Investigative Site | Cleveland | Ohio | 44130 | United States |
| IONIS Investigative Site | Cleveland | Ohio | 44195 | United States |
| IONIS Investigative Site | Tulsa | Oklahoma | 74114 | United States |
| IONIS Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| IONIS Investigative Site | Pittsburgh | Pennsylvania | 15213 | United States |
| IONIS Investigative Site | West Mifflin | Pennsylvania | 15122 | United States |
| IONIS Investigative Site | Greenville | South Carolina | 29605 | United States |
| IONIS Investigative Site | Ladson | South Carolina | 29456 | United States |
| IONIS Investigative Site | Nashville | Tennessee | 37203 | United States |
| IONIS Investigative Site | Abilene | Texas | 79606 | United States |
| IONIS Investigative Site | Arlington | Texas | 76012 | United States |
| IONIS Investigative Site | Austin | Texas | 78705 | United States |
| IONIS Investigative Site | Bellaire | Texas | 77401 | United States |
| IONIS Investigative Site | Dallas | Texas | 75231 | United States |
| IONIS Investigative Site | McAllen | Texas | 78503 | United States |
| IONIS Investigative Site | San Antonio | Texas | 78240 | United States |
| IONIS Investigative Site | Southlake | Texas | 76051 | United States |
| IONIS Investigative Site | The Woodlands | Texas | 77384 | United States |
| IONIS Investigative Site | Willow Park | Texas | 76087 | United States |
| IONIS Investigative Site | Salt Lake City | Utah | 84107 | United States |
| IONIS Investigative Site | Lynchburg | Virginia | 24502 | United States |
| IONIS Investigative Site | Richmond | Virginia | 23235 | United States |
| IONIS Investigative Site | Silverdale | Washington | 98383 | United States |
| IONIS Investigative Site | Albury | New South Wales | 2640 | Australia |
| IONIS Investigative Site | Hurstville | New South Wales | 2228 | Australia |
| IONIS Investigative Site | Parramatta | New South Wales | 2150 | Australia |
| IONIS Investigative Site | Sydney | New South Wales | 2000 | Australia |
| IONIS Investigative Site | Adelaide | South Australia | 5000 | Australia |
| IONIS Investigative Site | East Melbourne | Victoria | 3002 | Australia |
| IONIS Investigative Site | Essendon | Victoria | 3040 | Australia |
| IONIS Investigative Site | Glen Iris | Victoria | 3146 | Australia |
| IONIS Investigative Site | Malvern | Victoria | 3144 | Australia |
| IONIS Investigative Site | Parkville | Victoria | 3050 | Australia |
| IONIS Investigative Site | Perth | Western Australia | 6009 | Australia |
| IONIS Investigative Site | Linz | Upper Austria | 4020 | Austria |
| IONIS Investigative Site | Klagenfurt | 9020 | Austria |
| IONIS Investigative Site | Vienna | 1090 | Austria |
| IONIS Investigative Site | Vienna | 1140 | Austria |
| IONIS Investigative Site | London | Ontario | N6A 4V2 | Canada |
| IONIS Investigative Site | Ottawa | Ontario | K1H 8L6 | Canada |
| IONIS Investigative Site | Ottawa | Ontario | K2B 7E9 | Canada |
| IONIS Investigative Site | Québec | Quebec | G1S 4L8 | Canada |
| IONIS Investigative Site | Prague | 15000 | Czechia |
| IONIS Investigative Site | Nijmegen | Gelderland | 6525EX | Netherlands |
| IONIS Investigative Site | Rotterdam | 3011 BH | Netherlands |
| IONIS Investigative Site | Christchurch | 8013 | New Zealand |
| IONIS Investigative Site | Katowice | Silesian | 40-514 | Poland |
| IONIS Investigative Site | Bydgoszcz | 85-631 | Poland |
| IONIS Investigative Site | Terrassa | Barcelona | 8227 | Spain |
| IONIS Investigative Site | Majadahonda | Madrid | 28222 | Spain |
| IONIS Investigative Site | Pamplona | Navarre | 31008 | Spain |
| IONIS Investigative Site | Burjassot | Valencia | 46100 | Spain |
| IONIS Investigative Site | Barcelona | 8022 | Spain |
| IONIS Investigative Site | Barcelona | 8034 | Spain |
| IONIS Investigative Site | Valladolid | 47012 | Spain |
| IONIS Investigative Site | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided