Macular Edema Secondary to Inflammation study: KSI-101
Official 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
ClinicalTrials.gov ID: NCT06990399
What this study is testing
What is KSI-101?
This is an investigational medicine being studied as a potential treatment for macular edema caused by inflammation.
Also referred to as tabirafusp alfa.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the new eye injection called KSI-101 is safe and works well for treating macular edema.
- Who it's for
- People who have macular edema, which is swelling in the center of the retina, caused by inflammation.
- What's involved
- Participants will receive an injection of KSI-101 into the eye and undergo regular eye exams and tests to check for changes in vision and swelling.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD.
- Active or suspected ocular or periocular infection in either eye.
- Any history of or active occlusive retinal vasculitis in either eye.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Bakersfield, California, United States
- Glendale, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- Pasadena, California, United States
- Redlands, California, United States
- Sacramento, California, United States
- Denver, Colorado, United States
- Greenwich, Connecticut, United States
- Manchester, Connecticut, United States
- Waterford, Connecticut, United States
- Fort Lauderdale, Florida, United States
- St. Petersburg, Florida, United States
- Elmhurst, Illinois, United States
- Carmel, Indiana, United States
- Hagerstown, Maryland, United States
- Boston, Massachusetts, United States
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Bakersfield, California, United States; Glendale, California, United States; La Jolla, California, United States; Los Angeles, California, United States and 40 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.