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A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tarcocimab tedromer 5 mg (KSI-301) | Experimental | Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks. |
|
| Tabirafusp tedromer 5 mg (KSI-501) | Experimental | Intravitreal injection of tabirafusp tedromer once every 4 weeks for 4 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing) |
|
| Aflibercept 2 mg | Active Comparator | Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarcocimab tedromer | Drug | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity (BCVA) | Mean change in BCVA from Day 1 to Year 1 | Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Velazquez-Martin, MD | Kodiak Sciences Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Gilbert | Arizona | 85297 | United States | ||
| Associated Retina Consultants |
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Participants will be randomized 1:1:1 into one of three treatment groups: tarcocimab-ted, tabirafusp-ted or aflibercept.
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| Tabirafusp tedromer | Drug | Intravitreal injection |
|
|
| Aflibercept | Drug | Intravitreal injection |
|
|
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Retina Macula Institute of Arizona | Scottsdale | Arizona | 85255 | United States |
| Retina Associates SW | Tucson | Arizona | 85704 | United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Global Research Management, Inc. - Lugene Eye Institute | Glendale | California | 91204 | United States |
| Retinal Consultants Medical Group, Inc. | Modesto | California | 95356 | United States |
| California Eye Specialists Medical Group, Inc. | Pasadena | California | 91107 | United States |
| California Eye Specialists Medical Group, Inc. | Redlands | California | 92373 | United States |
| Retinal Consultants Medical Group Inc | Sacramento | California | 95825 | United States |
| Retina Consultants of Southern Colorado | Colorado Springs | Colorado | 80909 | United States |
| Retina Group of New England, PC | Waterford | Connecticut | 06385 | United States |
| Blue Ocean Clinical Research | Clearwater | Florida | 33761 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Retina Group of Florida | Sarasota | Florida | 34232 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Retina Associates, Ltd | Elmhurst | Illinois | 60126 | United States |
| Illinois Retina Associates | Oak Park | Illinois | 60304 | United States |
| Associated Vitreoretinal and Uveitis Consultants LLC | Carmel | Indiana | 46032 | United States |
| Midwest Eye Institute | Carmel | Indiana | 46290 | United States |
| The Retina Care Center | Baltimore | Maryland | 21209 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Retina Consultants of Minnesota | Edina | Minnesota | 55435 | United States |
| Retina Consultants of Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Mississippi Retina Associates | Madison | Mississippi | 39110 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| Retina Consultants of Nevada | Henderson | Nevada | 89052 | United States |
| Long Island Vitreoretinal Consultants | Hauppauge | New York | 11788 | United States |
| Retina Vitreous Surgeons of CNY PC | Liverpool | New York | 13088 | United States |
| Retina Associates of Western NY | Rochester | New York | 14620 | United States |
| Asheville Eye Associates | Asheville | North Carolina | 28803 | United States |
| North Carolina Retina Associates | Cary | North Carolina | 27511 | United States |
| Piedmont Retina Specialist | Greensboro | North Carolina | 27401 | United States |
| Graystone Eye | Hickory | North Carolina | 28602 | United States |
| North Carolina Retina Associates | Wake Forest | North Carolina | 27587 | United States |
| Western Carolina Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Retina Northwest | Portland | Oregon | 97210 | United States |
| Cascade Medical Research Institute | Springfield | Oregon | 97477 | United States |
| Erie Retina Research | Erie | Pennsylvania | 16507 | United States |
| Vision Research Solutions PLLC | Philadelphia | Pennsylvania | 19141 | United States |
| Palmetto Retina Center | Aiken | South Carolina | 29802 | United States |
| Charleston Neuroscience Institute, LLC | Beaufort | South Carolina | 29902 | United States |
| Charleston Neuroscience Institute, LLC | Charleston | South Carolina | 29414 | United States |
| Charleston Neuroscience Institute, LLC | Ladson | South Carolina | 29456 | United States |
| Charleston Neuroscience Institute | Mt. Pleasant | South Carolina | 29464 | United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Ophthalmology Ltd | Sioux Falls | South Dakota | 57108 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Panhandle Eye Group, LLP. - Southwest Retina Specialists | Amarillo | Texas | 79106 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Austin Research Center for Retina | Austin | Texas | 78705 | United States |
| Austin Retina Associates, PLLC | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Star Vision Research | Burleson | Texas | 76028 | United States |
| Texas Retina Associates | Fort Worth | Texas | 76104 | United States |
| Texas Retina Center | Houston | Texas | 77030 | United States |
| Retina Consultants of Texas | Katy | Texas | 77494 | United States |
| Texas Retina Associates | Plano | Texas | 75075 | United States |
| Austin Retina Associates, PLLC | Round Rock | Texas | 78681 | United States |
| Retinal Consultants of Houston dba Retina Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | Schertz | Texas | 78154 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| Pacific Northwest Retina | Bellevue | Washington | 98004 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| Eye Clinic of Wisconsin | Wausau | Wisconsin | 54403 | United States |
| Emanuelli Research & Development Center, LLC | Arecibo | 00612 | Puerto Rico |
| ID | Term |
|---|---|
| C533178 | aflibercept |
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