RECRUITINGPhase 3INTERVENTIONAL
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - 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
About This Trial
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- ME in the Study Eye secondary to diabetes, RVO, or wAMD
- Active or suspected ocular or periocular infection in either eye
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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.
Exclusion Criteria:
* ME in the Study Eye secondary to diabetes, RVO, or wAMD
* Active or suspected ocular or periocular infection in either eye
Treatments Being Tested
DRUG
KSI-101
Intravitreal injection
OTHER
Sham Comparator
Sham injections
Locations (20)
Research Network Arizona
Scottsdale, Arizona, United States
Global Research Management, Inc.
Glendale, California, United States
UCLA Stein Eye Institute
Los Angeles, California, United States
Stanford Byers Eye Institute
Palo Alto, California, United States
California Eye Specialists Medical Group, Inc.
Pasadena, California, United States
California Eye Specialists Medical Group, Inc.
Redlands, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
Retina Group of New England, PC
Waterford, Connecticut, United States
Retina Group of Florida (Ft. Lauderdale)
Fort Lauderdale, Florida, United States
Associated Vitreoretinal and Uveitis Consultants LLC
Carmel, Indiana, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, United States
The Retina Institute
St Louis, Missouri, United States
Retina Associates of New York, P.C.
New York, New York, United States
North Carolina Retina Associates (Cary)
Cary, North Carolina, United States
North Carolina Retina Associates (Wake Forest)
Wake Forest, North Carolina, United States
Cascade Medical Research Institute
Springfield, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
Charleston Neuroscience Institute, LLC (Charleston)
Charleston, South Carolina, United States