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

Kodiak Sciences

Status and phase: Not yet enrolling; Phase 3

Conditions: Macular Edema Secondary to Inflammation

Treatments: Other: Sham Comparator; Drug: KSI-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06990399

KSMP001-S1

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• MESI with a central subfield thickness (CST) of ≥400 microns on SD-OCT in 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

• ME in the Study Eye secondary to diabetes, RVO, or wAMD
• Active or suspected ocular or periocular infection in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

KSI-101 5 mg

Experimental group

Description:

Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing

Treatment:

Drug: KSI-101

KSI-101 10 mg

Experimental group

Description:

Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing

Treatment:

Drug: KSI-101

Sham

Sham Comparator group

Description:

Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing

Treatment:

Other: Sham Comparator