A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
PINNACLE
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) - PINNACLE
1 other identifier
interventional
150
1 country
33
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2025
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedStudy Start
First participant enrolled
July 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
September 12, 2025
September 1, 2025
1.4 years
May 21, 2025
September 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in BCVA
Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
Week 24
Study Arms (3)
KSI-101 5 mg
EXPERIMENTALIntravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
KSI-101 10 mg
EXPERIMENTALIntravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
Sham
SHAM COMPARATORSham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing
Interventions
Eligibility Criteria
You may qualify if:
- Patients with MESI, with a 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 at Day 1;
- Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
You may not qualify if:
- ME in the Study Eye secondary to diabetes, RVO, or wAMD
- Active or suspected ocular or periocular infection in either eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2025
First Posted
May 30, 2025
Study Start
July 16, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share