A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
Recruiting
Phase 3
Interventional Study
Macular Edema Secondary to Inflammation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 600 (estimated)
- Sponsor
- Kodiak Sciences Inc · Industry
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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)
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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/…
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