Back to Trials
NCT06990399PHASE3Recruiting

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK

Kodiak Sciences Inc

Start Date

7/30/2025

Completion Date

11/1/2027

Summary

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye. * Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye. * BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye. * Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye. Exclusion Criteria: * Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD. * Active or suspected ocular or periocular infection in either eye. * Any history of or active occlusive retinal vasculitis in either eye.

Interventions

DRUG

KSI-101

OTHER

Sham Comparator

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Macular Edema Secondary to Inflammation

Locations

AZ Retina & Vitreous Consultants

Phoenix, Arizona 85016

United States

Research Network Arizona

Scottsdale, Arizona 85255

United States

California Retina Consultants (Bakersfield)

Bakersfield, California 93309

United States

Global Research Management, Inc.

Glendale, California 91204

United States

UCSD/Jacobs Retina Center

La Jolla, California 92093

United States

UCLA Stein Eye Institute

Los Angeles, California 90095

United States

California Retina Consultants (Oxnard)

Oxnard, California 93036

United States

Stanford Byers Eye Institute

Palo Alto, California 94303

United States

California Eye Specialists Medical Group, Inc.

Pasadena, California 91107

United States

California Eye Specialists Medical Group, Inc.

Redlands, California 92373

United States

Retina Consultants of Southern California

Redlands, California 92374

United States

Retinal Consultants Medical Group Inc

Sacramento, California 95841

United States

Retina Specialists of Colorado (RSC)

Denver, Colorado 80222

United States

Rocky Mountain Uveitis

Denver, Colorado 80246

United States

Coastal Eye Surgeons

Greenwich, Connecticut 06830

United States

Retina Consultants, PC

Manchester, Connecticut 06042

United States

Retina Group of New England, PC

Waterford, Connecticut 06385

United States

Florida Eye Clinic

Altamonte Springs, Florida 32701

United States

Retina Group of Florida (Ft. Lauderdale)

Fort Lauderdale, Florida 33308

United States

Retina Vitreous Associates of Florida (St. Petersburg)

St. Petersburg, Florida 33711

United States

Retina Associates, LTD

Elmhurst, Illinois 60126

United States

Associated Vitreoretinal and Uveitis Consultants LLC

Carmel, Indiana 46032

United States

Midwest Eye Institute

Carmel, Indiana 46032

United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland 21740

United States

Ophthalmic Consultants of Boston

Boston, Massachusetts 02114

United States

Retina Consultants of Minnesota

Saint Louis Park, Minnesota 55416

United States

The Retina Institute

St Louis, Missouri 63128

United States

St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute)

Palisades Park, New Jersey 07650

United States

Eye Associates of New Mexico, Vision Research Center

Albuquerque, New Mexico 87109

United States

Retina Associates of New York, P.C.

New York, New York 10075

United States

North Carolina Retina Associates (Cary)

Cary, North Carolina 27511

United States

North Carolina Retina Associates (Wake Forest)

Wake Forest, North Carolina 27587

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Ohio State University

Columbus, Ohio 43212

United States

Cascade Medical Research Institute

Springfield, Oregon 97477

United States

Erie Retina Research

Erie, Pennsylvania 16507

United States

Vision Research Solutions

Philadelphia, Pennsylvania 19141

United States

Charleston Neuroscience Institute, LLC (Charleston)

Charleston, South Carolina 29414

United States

Palmetto Retina Center (West Columbia)

West Columbia, South Carolina 29169

United States

Ophthalmology Ltd

Sioux Falls, South Dakota 57108

United States

Tennessee Retina PC

Nashville, Tennessee 37203

United States

Vanderbilt Eye Institute

Nashville, Tennessee 37232

United States

Retina Research Institute of Texas

Abilene, Texas 70606

United States

Austin Retina Associates, PLLC (Austin)

Austin, Texas 78705

United States

UT Austin

Austin, Texas 78712

United States

Retina Consultants of Texas (Bellaire)

Bellaire, Texas 77401

United States

Texas Retina Center

Houston, Texas 77030

United States

Retina Consultants of Texas (Katy)

Katy, Texas 77494

United States

Texas Retina Associates (Plano)

Plano, Texas 75075

United States

Austin Retina Associates, PLLC (Round Rock)

Round Rock, Texas 78681

United States

Retina Consultants of Texas (San Antonio)

San Antonio, Texas 78240

United States

Retina Consultants of Texas (Woodlands)

The Woodlands, Texas 77384

United States

Pacific Northwest Retina (Bellevue)

Bellevue, Washington 98004

United States

Pacific Northwest Retina (Silverdale)

Silverdale, Washington 98383

United States

Eye Clinic of Wisconsin

Wausau, Wisconsin 54403

United States

Centro Oftalmologico Metropolitano

San Juan, 00921

Puerto Rico