RECRUITING

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

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Conditions

Macular Edema Secondary to InflammationMESImacular edemainflammatory macular edemamacular edema associated with inflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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) - PEAK

Quick Facts

Study Start:2025-07-30
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06990399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * MESI with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye.
  2. * BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye.
  3. * Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
  1. * ME in the Study Eye secondary to diabetes, RVO, or wAMD
  2. * Active or suspected ocular or periocular infection in either eye

Contacts and Locations

Study Contact

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

Principal Investigator

Pablo Velazquez-Martin, MD
STUDY_DIRECTOR
Kodiak Sciences Inc

Study Locations (Sites)

Research Network Arizona
Scottsdale, Arizona, 85255
United States
Global Research Management, Inc.
Glendale, California, 91204
United States
UCLA Stein Eye Institute
Los Angeles, California, 90095
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 Group of New England, PC
Waterford, Connecticut, 06385
United States
Retina Group of Florida (Ft. Lauderdale)
Fort Lauderdale, Florida, 33308
United States
Associated Vitreoretinal and Uveitis Consultants LLC
Carmel, Indiana, 46032
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, 55416
United States
The Retina Institute
St Louis, Missouri, 63128
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
Cascade Medical Research Institute
Springfield, Oregon, 97477
United States
Erie Retina Research
Erie, Pennsylvania, 16507
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
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
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

Collaborators and Investigators

Sponsor: Kodiak Sciences Inc

  • Pablo Velazquez-Martin, MD, STUDY_DIRECTOR, Kodiak Sciences Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • MESI
  • macular edema
  • inflammatory macular edema
  • macular edema associated with inflammation

Additional Relevant MeSH Terms

  • Macular Edema Secondary to Inflammation