NCT06990399RecruitingPhase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
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
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 17 May 2025
- Start date
- Jul 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Kodiak Sciences Inc
- NCT number
- NCT06990399
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From Jul 2025 to the primary completion date, Apr 2027
- 56 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active or suspected ocular or periocular infection in either eye.
- Any history of or active occlusive retinal vasculitis in either eye.
Other
- Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD.
Who the study is looking for
- Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye.
- Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye.
- BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye.
- Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Oftalmologico Metropolitano Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Retina Research Institute of Texas Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| Eye Associates of New Mexico Vision Research Center Coordinator of this site? Confirm its status | Albuquerque | United States | Not yet recruiting |
| Florida Eye Clinic Coordinator of this site? Confirm its status | Altamonte Springs | United States | Not yet recruiting |
| Austin Retina Associates, PLLC (Austin) Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| UT-Austin Coordinator of this site? Confirm its status | Austin | United States | Not yet recruiting |
| California Retina Consultants (Bakersfield) Coordinator of this site? Confirm its status | Bakersfield | United States | Recruiting |
| Retina Consultants of Texas (Bellaire) Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Pacific Northwest Retina (Bellevue) Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Ophthalmic Consultants of Boston Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Associated Vitreoretinal and Uveitis Consultants LLC Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| Midwest Eye Institute Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| North Carolina Retina Associates (Cary) Coordinator of this site? Confirm its status | Cary | United States | Recruiting |
| Charleston Neuroscience Institute LLC - Charleston Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Retina Specialists of Colorado (RSC) Coordinator of this site? Confirm its status | Denver | United States | Withdrawn |
| Rocky Mountain Uveitis Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Retina Associates, Ltd. Coordinator of this site? Confirm its status | Elmhurst | United States | Recruiting |
| Erie Retina Research Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| Retina Group of Florida (Ft. Lauderdale) Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Recruiting |
| Global Research Management, Inc Coordinator of this site? Confirm its status | Glendale | United States | Recruiting |
| Coastal Eye Surgeons Coordinator of this site? Confirm its status | Greenwich | United States | Recruiting |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Recruiting |
| Texas Retina Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Retina Consultants of Texas - Katy Coordinator of this site? Confirm its status | Katy | United States | Recruiting |
| UCSD/Jacobs Retina Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| UCLA Stein Eye Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Retina Consultants PC Coordinator of this site? Confirm its status | Manchester | United States | Recruiting |
| Tennessee Retina, PC Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Vanderbilt Eye Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Retina Associates of New York, P.C. Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| California Retina Consultants (Oxnard) Coordinator of this site? Confirm its status | Oxnard | United States | Recruiting |
| St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute) Coordinator of this site? Confirm its status | Palisades Park | United States | Recruiting |
| Stanford Byers Eye Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Not yet recruiting |
| California Eye Specialists Medical Group, Inc. Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
| Vision Research Solutions Coordinator of this site? Confirm its status | Philadelphia | United States | Withdrawn |
| AZ Retina & Vitreous Consultants Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Texas Retina Associates (Plano) Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Retina Consultants of Southern California Coordinator of this site? Confirm its status | Redlands | United States | Recruiting |
| California Eye Specialists Medical Group, Inc. Coordinator of this site? Confirm its status | Redlands | United States | Recruiting |
| Austin Retina Associates, PLLC (Round Rock) Coordinator of this site? Confirm its status | Round Rock | United States | Recruiting |
| Retinal Consultants Medical Group, Inc. Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Retina Consultants of Minnesota Coordinator of this site? Confirm its status | Saint Louis Park | United States | Recruiting |
| Retina Consultants of Texas: San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Research Network Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Pacific Northwest Retina (Silverdale) Coordinator of this site? Confirm its status | Silverdale | United States | Recruiting |
| Ophthalmology Ltd. Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Cascade Medical Research Institute Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| The Retina Institute Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Retina Vitreous Associates of Florida (St. Petersburg) Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Retina Consultants of Texas (Woodlands) Coordinator of this site? Confirm its status | The Woodlands | United States | Recruiting |
| North Carolina Retina Associates (Wake Forest) Coordinator of this site? Confirm its status | Wake Forest | United States | Recruiting |
| Retina Group of New England, PC Coordinator of this site? Confirm its status | Waterford | United States | Recruiting |
| Eye Clinic of Wisconsin Coordinator of this site? Confirm its status | Wausau | United States | Recruiting |
| Palmetto Retina Center (West Columbia) Coordinator of this site? Confirm its status | West Columbia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.