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Tests treatment safety and results for Macular Edema Secondary to Inflammation
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) - PINNACLE
ClinicalTrials.gov ID: NCT06996080
What this study is testing
What is KSI-101?
KSI-101 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for macular edema secondary to 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
- A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
- 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 ≥320 and \<400 microns on SD-OCT and a BCVA score of ≥25...
- Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT 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
- ME in the Study Eye secondary to diabetes, 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's taking place
- 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
- Palo Alto, 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
- Altamonte Springs, Florida, United States
- Fort Lauderdale, Florida, United States
- St. Petersburg, Florida, United States
- Elmhurst, Illinois, United States
- Carmel, Indiana, United States
+ 31 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 - 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?
Study sites include 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 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.