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

Phase 3

Not yet recruiting

• Conditions: Macular Edema Secondary to Inflammation
• Interventions: Drug: KSI-101; Other: Sham Comparator

• Registration Number: NCT06996080
• Lead Sponsor: Kodiak Sciences Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Study Start: 2025-07
• Primary Completion: 2026-12
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with MESI, with a CST of ≥320 and <400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between ~20/25 and 20/320 Snellen equivalent) in the Study Eye at Day 1;
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KSI-101 5 mg	KSI-101	Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
KSI-101 10 mg	KSI-101	Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
Sham	Sham Comparator	Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing

Primary Outcome Measures

Name	Time	Method
Mean change in BCVA	Week 24	Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.