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

Purpose

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

Condition

  • Macular Edema Secondary to Inflammation

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KSI-101 5 mg 		Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
  • Drug: KSI-101
    Intravitreal injection
    Other names:
    • tabirafusp alfa
Experimental
KSI-101 10 mg 		Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
  • Drug: KSI-101
    Intravitreal injection
    Other names:
    • tabirafusp alfa
Sham Comparator
Sham 		Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing
  • Other: Sham Comparator
    Sham injections

Recruiting Locations

AZ Retina & Vitreous Consultants
Phoenix, Arizona 85016

Research Network Arizona
Scottsdale, Arizona 85255

California Retina Consultants (Bakersfield)
Bakersfield, California 93309

Global Research Management, Inc.
Glendale, California 91204

UCSD/Jacobs Retina Center
La Jolla, California 92093

UCLA Stein Eye Institute
Los Angeles, California 90095

California Retina Consultants (Oxnard)
Oxnard, California 93036

California Eye Specialists Medical Group, Inc.
Pasadena, California 91107

California Eye Specialists Medical Group, Inc.
Redlands, California 92373

Retina Consultants of Southern California
Redlands, California 92374

Retinal Consultants Medical Group Inc
Sacramento, California 95841

Rocky Mountain Uveitis
Denver, Colorado 80246

Coastal Eye Surgeons
Greenwich, Connecticut 06830

Retina Consultants, PC
Manchester, Connecticut 06042

Retina Group of New England, PC
Waterford, Connecticut 06385

Retina Group of Florida (Ft. Lauderdale)
Fort Lauderdale, Florida 33308

Retina Vitreous Associates of Florida (St. Petersburg)
St. Petersburg, Florida 33711

Retina Associates, LTD
Elmhurst, Illinois 60126

Associated Vitreoretinal and Uveitis Consultants LLC
Carmel, Indiana 46032

Midwest Eye Institute
Carmel, Indiana 46032

Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740

Ophthalmic Consultants of Boston
Boston, Massachusetts 02114

Retina Consultants of Minnesota
Saint Louis Park, Minnesota 55416

The Retina Institute
St Louis, Missouri 63128

St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute)
Palisades Park, New Jersey 07650

Retina Associates of New York, P.C.
New York, New York 10075

North Carolina Retina Associates (Cary)
Cary, North Carolina 27511

North Carolina Retina Associates (Wake Forest)
Wake Forest, North Carolina 27587

Ohio State University
Columbus, Ohio 43212

Cascade Medical Research Institute
Springfield, Oregon 97477

Erie Retina Research
Erie, Pennsylvania 16507

Charleston Neuroscience Institute, LLC (Charleston)
Charleston, South Carolina 29414

Palmetto Retina Center (West Columbia)
West Columbia, South Carolina 29169

Ophthalmology Ltd
Sioux Falls, South Dakota 57108

Tennessee Retina PC
Nashville, Tennessee 37203

Vanderbilt Eye Institute
Nashville, Tennessee 37232

Retina Research Institute of Texas
Abilene, Texas 79606

Austin Retina Associates, PLLC (Austin)
Austin, Texas 78705

Retina Consultants of Texas (Bellaire)
Bellaire, Texas 77401

Texas Retina Center
Houston, Texas 77030

Retina Consultants of Texas (Katy)
Katy, Texas 77494

Texas Retina Associates (Plano)
Plano, Texas 75075

Austin Retina Associates, PLLC (Round Rock)
Round Rock, Texas 78681

Retina Consultants of Texas (San Antonio)
San Antonio, Texas 78240

Retina Consultants of Texas (Woodlands)
The Woodlands, Texas 77384

Pacific Northwest Retina (Bellevue)
Bellevue, Washington 98004

Pacific Northwest Retina (Silverdale)
Silverdale, Washington 98383

Eye Clinic of Wisconsin
Wausau, Wisconsin 54403

Centro Oftalmologico Metropolitano
San Juan, Puerto Rico 00921

More Details

Status
Recruiting
Sponsor
Kodiak Sciences Inc

Study Contact

Kodiak Sciences Inc
(650) 281-0850
ClinicalTrials@kodiak.com