A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK

Study Status: Recruiting

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)

Sex: ALL
Minimum Age: 18 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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 20/40 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.

Exclusion Criteria

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.

Conditions

Macular Edema Secondary to Inflammation

Intervention/Treatment

DRUG : KSI-101
OTHER : Sham Comparator

Sponsor

Kodiak Sciences Inc

Principal Investigator(s)

Pablo Velazquez-Martin, MD, STUDY_DIRECTOR, Kodiak Sciences Inc

Phase

PHASE3