Recruiting

Phase 3

KSI-101A 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

Code:

NCT06996080

Conditions

Macular Edema Secondary to Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KSI-101

Sham Comparator

Study Details

Brief summary:

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

Conditions

Macular Edema Secondary to Inflammation

Study ID

NCT06996080

Start date

Jul 16, 2025

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥320 and <400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between \~20/25 and 20/320 Snellen equivalent) in the Study Eye.
Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye.
Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.

Exclusion Criteria:

ME in the Study Eye secondary to diabetes, RVO, or wAMD.
Active or suspected ocular or periocular infection in either eye.
Any history of or active occlusive retinal vasculitis in either eye.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KSI-101 5 mg

Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing

experimental: KSI-101 10 mg

Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing

sham comparator: Sham

Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing

Interventions

KSI-101

Intravitreal injection

Sham Comparator

Sham injections

Primary outcome measure

Mean change in BCVA [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Kodiak Sciences Inc

(650) 281-0850 ClinicalTrials@kodiak.com

Locations

AZ Retina & Vitreous Consultants

Recruiting

Phoenix, Arizona, United States, 85016

Research Network Arizona

Recruiting

Scottsdale, Arizona, United States, 85255

California Retina Consultants (Bakersfield)

Recruiting

Bakersfield, California, United States, 93309

Global Research Management, Inc.

Recruiting

Glendale, California, United States, 91204

UCSD/Jacobs Retina Center

Recruiting

La Jolla, California, United States, 92093

UCLA Stein Eye Institute

Recruiting

Los Angeles, California, United States, 90095

California Retina Consultants (Oxnard)

Recruiting

Oxnard, California, United States, 93036

California Eye Specialists Medical Group, Inc.

Recruiting

Pasadena, California, United States, 91107

California Eye Specialists Medical Group, Inc.

Recruiting

Redlands, California, United States, 92373

Retina Consultants of Southern California

Recruiting

Redlands, California, United States, 92374

Retinal Consultants Medical Group Inc

Recruiting

Sacramento, California, United States, 95841

Rocky Mountain Uveitis

Recruiting

Denver, Colorado, United States, 80246

Coastal Eye Surgeons

Recruiting

Greenwich, Connecticut, United States, 06830

Retina Consultants, PC

Recruiting

Manchester, Connecticut, United States, 06042

Retina Group of New England, PC

Recruiting

Waterford, Connecticut, United States, 06385

Retina Group of Florida (Ft. Lauderdale)

Recruiting

Fort Lauderdale, Florida, United States, 33308

Retina Vitreous Associates of Florida (St. Petersburg)

Recruiting

St. Petersburg, Florida, United States, 33711

Retina Associates, LTD

Recruiting

Elmhurst, Illinois, United States, 60126

Associated Vitreoretinal and Uveitis Consultants LLC

Recruiting

Carmel, Indiana, United States, 46032

Midwest Eye Institute

Recruiting

Carmel, Indiana, United States, 46032

Cumberland Valley Retina Consultants

Recruiting

Hagerstown, Maryland, United States, 21740

Ophthalmic Consultants of Boston

Recruiting

Boston, Massachusetts, United States, 02114

Retina Consultants of Minnesota

Recruiting

Saint Louis Park, Minnesota, United States, 55416

The Retina Institute

Recruiting

St Louis, Missouri, United States, 63128

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

Recruiting

Palisades Park, New Jersey, United States, 07650

Retina Associates of New York, P.C.

Recruiting

New York, New York, United States, 10075

North Carolina Retina Associates (Cary)

Recruiting

Cary, North Carolina, United States, 27511

North Carolina Retina Associates (Wake Forest)

Recruiting

Wake Forest, North Carolina, United States, 27587

Ohio State University

Recruiting

Columbus, Ohio, United States, 43212

Cascade Medical Research Institute

Recruiting

Springfield, Oregon, United States, 97477

Erie Retina Research

Recruiting

Erie, Pennsylvania, United States, 16507

Charleston Neuroscience Institute, LLC (Charleston)

Recruiting

Charleston, South Carolina, United States, 29414

Palmetto Retina Center (West Columbia)

Recruiting

West Columbia, South Carolina, United States, 29169

Ophthalmology Ltd

Recruiting

Sioux Falls, South Dakota, United States, 57108

Tennessee Retina PC

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt Eye Institute

Recruiting

Nashville, Tennessee, United States, 37232

Retina Research Institute of Texas

Recruiting

Abilene, Texas, United States, 79606

Austin Retina Associates, PLLC (Austin)

Recruiting

Austin, Texas, United States, 78705

Retina Consultants of Texas (Bellaire)

Recruiting

Bellaire, Texas, United States, 77401

Texas Retina Center

Recruiting

Houston, Texas, United States, 77030

Retina Consultants of Texas (Katy)

Recruiting

Katy, Texas, United States, 77494

Texas Retina Associates (Plano)

Recruiting

Plano, Texas, United States, 75075

Austin Retina Associates, PLLC (Round Rock)

Recruiting

Round Rock, Texas, United States, 78681

Retina Consultants of Texas (San Antonio)

Recruiting

San Antonio, Texas, United States, 78240

Retina Consultants of Texas (Woodlands)

Recruiting

The Woodlands, Texas, United States, 77384

Pacific Northwest Retina (Bellevue)

Recruiting

Bellevue, Washington, United States, 98004

Pacific Northwest Retina (Silverdale)

Recruiting

Silverdale, Washington, United States, 98383

Eye Clinic of Wisconsin

Recruiting

Wausau, Wisconsin, United States, 54403

More Information

Sponsor

Kodiak Sciences Inc

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

MESI
macular edema
inflammatory macular edema
macular edema associated with inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kodiak Sciences Inc on 2026-05-18.