Actively Recruiting
A Randomized, Double-Masked, Sham-Controlled Phase 3 Study of Intravitreal KSI-101 Injections for Macular Edema Secondary to Inflammation (MESI)
Led by Kodiak Sciences Inc · Updated on 2026-05-18
600
Participants Needed
56
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of intravitreal KSI-101 injections in adults with macular edema caused by inflammation, called Macular Edema Secondary to Inflammation (MESI). This Phase 3 clinical trial aims to evaluate how well KSI-101 works compared to a sham injection in improving vision for people with this condition. Participants will receive one of three treatments: KSI-101 at 5 mg or 10 mg doses injected into the eye every 4 weeks for six months, followed by dosing tailored to individual needs, or a sham injection following the same schedule. The study is randomized, double-masked, and controlled to ensure unbiased results. During the trial, participants will undergo vision tests to measure changes in best-corrected visual acuity (BCVA) over 24 weeks. Researchers will monitor safety and treatment effects throughout the study. The trial is expected to run until November 2027, with participants receiving regular assessments and follow-ups to track their eye health and response to treatment.
CONDITIONS
Brief Title
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of Macular Edema Secondary to Inflammation (MESI) with central subfield thickness of 400 microns or more in the study eye
- Presence of intraretinal and/or subretinal fluid in the study eye
- Best-corrected visual acuity (BCVA) score between 25 and 70 letters (20/40 to 20/320 vision) in the study eye
- Diagnosis of active or inactive non-infectious intraocular inflammation in the study eye
You will not qualify if you...
- Macular edema in the study eye caused by diabetic retinopathy, retinal vein occlusion, or wet age-related macular degeneration
- Active or suspected infection in or around either eye
- History of or current occlusive retinal vasculitis in either eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 24 weeks or longer depending on individualized dosing
Participants receive intravitreal injections of KSI-101 or sham injections once every 4 weeks for 6 monthly doses followed by individualized dosing.
Monthly visits for the first 6 months, then visits as needed for individualized dosing
Trial Site Locations
Total: 56 locations
1
AZ Retina & Vitreous Consultants
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Research Network Arizona
Scottsdale, Arizona, United States, 85255
Actively Recruiting
3
California Retina Consultants (Bakersfield)
Bakersfield, California, United States, 93309
Actively Recruiting
4
Global Research Management, Inc.
Glendale, California, United States, 91204
Actively Recruiting
5
UCSD/Jacobs Retina Center
La Jolla, California, United States, 92093
Actively Recruiting
6
UCLA Stein Eye Institute
Los Angeles, California, United States, 90095
Actively Recruiting
7
California Retina Consultants (Oxnard)
Oxnard, California, United States, 93036
Actively Recruiting
8
Stanford Byers Eye Institute
Palo Alto, California, United States, 94303
Not Yet Recruiting
9
California Eye Specialists Medical Group, Inc.
Pasadena, California, United States, 91107
Actively Recruiting
10
California Eye Specialists Medical Group, Inc.
Redlands, California, United States, 92373
Actively Recruiting
11
Retina Consultants of Southern California
Redlands, California, United States, 92374
Actively Recruiting
12
Retinal Consultants Medical Group Inc
Sacramento, California, United States, 95841
Actively Recruiting
13
Retina Specialists of Colorado (RSC)
Denver, Colorado, United States, 80222
Withdrawn
14
Rocky Mountain Uveitis
Denver, Colorado, United States, 80246
Actively Recruiting
15
Coastal Eye Surgeons
Greenwich, Connecticut, United States, 06830
Actively Recruiting
16
Retina Consultants, PC
Manchester, Connecticut, United States, 06042
Actively Recruiting
17
Retina Group of New England, PC
Waterford, Connecticut, United States, 06385
Actively Recruiting
18
Florida Eye Clinic
Altamonte Springs, Florida, United States, 32701
Not Yet Recruiting
19
Retina Group of Florida (Ft. Lauderdale)
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
20
Retina Vitreous Associates of Florida (St. Petersburg)
St. Petersburg, Florida, United States, 33711
Actively Recruiting
21
Retina Associates, LTD
Elmhurst, Illinois, United States, 60126
Actively Recruiting
22
Associated Vitreoretinal and Uveitis Consultants LLC
Carmel, Indiana, United States, 46032
Actively Recruiting
23
Midwest Eye Institute
Carmel, Indiana, United States, 46032
Actively Recruiting
24
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
Actively Recruiting
25
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Actively Recruiting
26
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
27
The Retina Institute
St Louis, Missouri, United States, 63128
Actively Recruiting
28
St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute)
Palisades Park, New Jersey, United States, 07650
Actively Recruiting
29
Eye Associates of New Mexico, Vision Research Center
Albuquerque, New Mexico, United States, 87109
Not Yet Recruiting
30
Retina Associates of New York, P.C.
New York, New York, United States, 10075
Actively Recruiting
31
North Carolina Retina Associates (Cary)
Cary, North Carolina, United States, 27511
Actively Recruiting
32
North Carolina Retina Associates (Wake Forest)
Wake Forest, North Carolina, United States, 27587
Actively Recruiting
33
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
34
Ohio State University
Columbus, Ohio, United States, 43212
Actively Recruiting
35
Cascade Medical Research Institute
Springfield, Oregon, United States, 97477
Actively Recruiting
36
Erie Retina Research
Erie, Pennsylvania, United States, 16507
Actively Recruiting
37
Vision Research Solutions
Philadelphia, Pennsylvania, United States, 19141
Withdrawn
38
Charleston Neuroscience Institute, LLC (Charleston)
Charleston, South Carolina, United States, 29414
Actively Recruiting
39
Palmetto Retina Center (West Columbia)
West Columbia, South Carolina, United States, 29169
Actively Recruiting
40
Ophthalmology Ltd
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
41
Tennessee Retina PC
Nashville, Tennessee, United States, 37203
Actively Recruiting
42
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
Actively Recruiting
43
Retina Research Institute of Texas
Abilene, Texas, United States, 70606
Actively Recruiting
44
Austin Retina Associates, PLLC (Austin)
Austin, Texas, United States, 78705
Actively Recruiting
45
UT Austin
Austin, Texas, United States, 78712
Not Yet Recruiting
46
Retina Consultants of Texas (Bellaire)
Bellaire, Texas, United States, 77401
Actively Recruiting
47
Texas Retina Center
Houston, Texas, United States, 77030
Actively Recruiting
48
Retina Consultants of Texas (Katy)
Katy, Texas, United States, 77494
Actively Recruiting
49
Texas Retina Associates (Plano)
Plano, Texas, United States, 75075
Actively Recruiting
50
Austin Retina Associates, PLLC (Round Rock)
Round Rock, Texas, United States, 78681
Actively Recruiting
51
Retina Consultants of Texas (San Antonio)
San Antonio, Texas, United States, 78240
Actively Recruiting
52
Retina Consultants of Texas (Woodlands)
The Woodlands, Texas, United States, 77384
Actively Recruiting
53
Pacific Northwest Retina (Bellevue)
Bellevue, Washington, United States, 98004
Actively Recruiting
54
Pacific Northwest Retina (Silverdale)
Silverdale, Washington, United States, 98383
Actively Recruiting
55
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States, 54403
Actively Recruiting
56
Centro Oftalmologico Metropolitano
San Juan, Puerto Rico, 00921
Actively Recruiting
Research Team
K
Kodiak Sciences Inc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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