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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) - PINNACLE
Sponsor: Kodiak Sciences Inc
Summary
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
Official title: A Randomized, Double-masked, Sham-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Alfa (KSI-101) in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-07-16
Completion Date
2027-07
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
KSI-101
Intravitreal injection
Sham Comparator
Sham injections
Locations (33)
Research Network Arizona
Scottsdale, Arizona, United States
Global Research Management, Inc.
Glendale, California, United States
UCLA Stein Eye Institute
Los Angeles, California, United States
Stanford Byers Eye Institute
Palo Alto, California, United States
California Eye Specialists Medical Group, Inc.
Pasadena, California, United States
California Eye Specialists Medical Group, Inc.
Redlands, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
Retina Group of New England, PC
Waterford, Connecticut, United States
Retina Group of Florida (Ft. Lauderdale)
Fort Lauderdale, Florida, United States
Associated Vitreoretinal and Uveitis Consultants LLC
Carmel, Indiana, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, United States
The Retina Institute
St Louis, Missouri, United States
Retina Associates of New York, P.C.
New York, New York, United States
North Carolina Retina Associates (Cary)
Cary, North Carolina, United States
North Carolina Retina Associates (Wake Forest)
Wake Forest, North Carolina, United States
Cascade Medical Research Institute
Springfield, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
Charleston Neuroscience Institute, LLC (Charleston)
Charleston, South Carolina, United States
Palmetto Retina Center (West Columbia)
West Columbia, South Carolina, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Austin Retina Associates, PLLC (Austin)
Austin, Texas, United States
UT Austin
Austin, Texas, United States
Retina Consultants of Texas (Bellaire)
Bellaire, Texas, United States
Texas Retina Center
Houston, Texas, United States
Retina Consultants of Texas (Katy)
Katy, Texas, United States
Texas Retina Associates (Plano)
Plano, Texas, United States
Austin Retina Associates, PLLC (Round Rock)
Round Rock, Texas, United States
Retina Consultants of Texas (San Antonio)
San Antonio, Texas, United States
Retina Consultants of Texas (Woodlands)
The Woodlands, Texas, United States
Pacific Northwest Retina (Bellevue)
Bellevue, Washington, United States
Pacific Northwest Retina (Silverdale)
Silverdale, Washington, United States