A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
NCT ID: NCT06996080
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2025-07-16
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KSI-101 5 mg
Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
KSI-101
Intravitreal injection
KSI-101 10 mg
Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
KSI-101
Intravitreal injection
Sham
Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing
Sham Comparator
Sham injections
Interventions
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KSI-101
Intravitreal injection
Sham Comparator
Sham injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
Exclusion Criteria
* Active or suspected ocular or periocular infection in either eye
18 Years
ALL
No
Sponsors
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Kodiak Sciences Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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KSMP001-S2
Identifier Type: -
Identifier Source: org_study_id
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