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A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSI-101 5 mg | Experimental | Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing |
|
| KSI-101 10 mg | Experimental | Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing |
|
| Sham | Sham Comparator | Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSI-101 | Drug | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in BCVA | Mean change in BCVA from Day 1 to the average of Week 20 and Week 24. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with BCVA improvement | The proportion of participants in whom BCVA had improved by ≥15 letters from baseline to 24 weeks. | Baseline to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kodiak Sciences Inc | Contact | (650) 281-0850 | ClinicalTrials@kodiak.com |
| Name | Affiliation | Role |
|---|---|---|
| Pablo Velazquez-Martin, MD | Kodiak Sciences Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Retina & Vitreous Consultants | Recruiting | Phoenix | Arizona | 85016 | United States | |
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| Sham Comparator | Other | Sham injections |
|
| Research Network Arizona |
| Recruiting |
| Scottsdale |
| Arizona |
| 85255 |
| United States |
| California Retina Consultants (Bakersfield) | Recruiting | Bakersfield | California | 93309 | United States |
| Global Research Management, Inc. | Recruiting | Glendale | California | 91204 | United States |
| UCSD/Jacobs Retina Center | Recruiting | La Jolla | California | 92093 | United States |
| UCLA Stein Eye Institute | Recruiting | Los Angeles | California | 90095 | United States |
| California Retina Consultants (Oxnard) | Recruiting | Oxnard | California | 93036 | United States |
| Stanford Byers Eye Institute | Not yet recruiting | Palo Alto | California | 94303 | United States |
| California Eye Specialists Medical Group, Inc. | Recruiting | Pasadena | California | 91107 | United States |
| California Eye Specialists Medical Group, Inc. | Recruiting | Redlands | California | 92373 | United States |
| Retina Consultants of Southern California | Recruiting | Redlands | California | 92374 | United States |
| Retinal Consultants Medical Group Inc | Recruiting | Sacramento | California | 95841 | United States |
| Retina Specialists of Colorado (RSC) | Withdrawn | Denver | Colorado | 80222 | United States |
| Rocky Mountain Uveitis | Recruiting | Denver | Colorado | 80246 | United States |
| Coastal Eye Surgeons | Recruiting | Greenwich | Connecticut | 06830 | United States |
| Retina Consultants, PC | Recruiting | Manchester | Connecticut | 06042 | United States |
| Retina Group of New England, PC | Recruiting | Waterford | Connecticut | 06385 | United States |
| Florida Eye Clinic | Not yet recruiting | Altamonte Springs | Florida | 32701 | United States |
| Retina Group of Florida (Ft. Lauderdale) | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
| Retina Vitreous Associates of Florida (St. Petersburg) | Recruiting | St. Petersburg | Florida | 33711 | United States |
| Retina Associates, LTD | Recruiting | Elmhurst | Illinois | 60126 | United States |
| Associated Vitreoretinal and Uveitis Consultants LLC | Recruiting | Carmel | Indiana | 46032 | United States |
| Midwest Eye Institute | Recruiting | Carmel | Indiana | 46032 | United States |
| Cumberland Valley Retina Consultants | Recruiting | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Recruiting | Boston | Massachusetts | 02114 | United States |
| Retina Consultants of Minnesota | Recruiting | Saint Louis Park | Minnesota | 55416 | United States |
| The Retina Institute | Recruiting | St Louis | Missouri | 63128 | United States |
| St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute) | Recruiting | Palisades Park | New Jersey | 07650 | United States |
| Eye Associates of New Mexico, Vision Research Center | Not yet recruiting | Albuquerque | New Mexico | 87109 | United States |
| Retina Associates of New York, P.C. | Recruiting | New York | New York | 10075 | United States |
| North Carolina Retina Associates (Cary) | Recruiting | Cary | North Carolina | 27511 | United States |
| North Carolina Retina Associates (Wake Forest) | Recruiting | Wake Forest | North Carolina | 27587 | United States |
| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Recruiting | Columbus | Ohio | 43212 | United States |
| Cascade Medical Research Institute | Recruiting | Springfield | Oregon | 97477 | United States |
| Erie Retina Research | Recruiting | Erie | Pennsylvania | 16507 | United States |
| Vision Research Solutions | Withdrawn | Philadelphia | Pennsylvania | 19141 | United States |
| Charleston Neuroscience Institute, LLC (Charleston) | Recruiting | Charleston | South Carolina | 29414 | United States |
| Palmetto Retina Center (West Columbia) | Recruiting | West Columbia | South Carolina | 29169 | United States |
| Ophthalmology Ltd | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
| Tennessee Retina PC | Recruiting | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Eye Institute | Recruiting | Nashville | Tennessee | 37232 | United States |
| Retina Research Institute of Texas | Recruiting | Abilene | Texas | 70606 | United States |
| Austin Retina Associates, PLLC (Austin) | Recruiting | Austin | Texas | 78705 | United States |
| UT Austin | Not yet recruiting | Austin | Texas | 78712 | United States |
| Retina Consultants of Texas (Bellaire) | Recruiting | Bellaire | Texas | 77401 | United States |
| Texas Retina Center | Recruiting | Houston | Texas | 77030 | United States |
| Retina Consultants of Texas (Katy) | Recruiting | Katy | Texas | 77494 | United States |
| Texas Retina Associates (Plano) | Recruiting | Plano | Texas | 75075 | United States |
| Austin Retina Associates, PLLC (Round Rock) | Recruiting | Round Rock | Texas | 78681 | United States |
| Retina Consultants of Texas (San Antonio) | Recruiting | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas (Woodlands) | Recruiting | The Woodlands | Texas | 77384 | United States |
| Pacific Northwest Retina (Bellevue) | Recruiting | Bellevue | Washington | 98004 | United States |
| Pacific Northwest Retina (Silverdale) | Recruiting | Silverdale | Washington | 98383 | United States |
| Eye Clinic of Wisconsin | Recruiting | Wausau | Wisconsin | 54403 | United States |
| Centro Oftalmologico Metropolitano | Recruiting | San Juan | 00921 | Puerto Rico |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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