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

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

• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-30
• Study Start: 2025-07-16
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-06
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-12
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: 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.

Trial Locations

Locations (32)

Research Network Arizona; 🇺🇸 Scottsdale, Arizona, United States

Global Research Management, Inc.; 🇺🇸 Glendale, California, United States

UCLA Stein Eye Institute; 🇺🇸 Los Angeles, California, United States

Stanford Byers Eye Institute; 🇺🇸 Palo Alto, California, United States

California Eye Specialists Medical Group, Inc.; 🇺🇸 Redlands, California, United States

Retina Consultants of Southern California; 🇺🇸 Redlands, California, United States

Retinal Consultants Medical Group Inc; 🇺🇸 Sacramento, California, United States

Retina Group of New England, PC; 🇺🇸 Waterford, Connecticut, United States

Retina Group of Florida (Ft. Lauderdale); 🇺🇸 Fort Lauderdale, Florida, United States

Associated Vitreoretinal and Uveitis Consultants LLC; 🇺🇸 Carmel, Indiana, United States

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